The feasibility and acceptability of a single-session Acceptance and Commitment Therapy (ACT) intervention to support women self-reporting fear of childbirth in a first pregnancy

Abstract

Objective

To assess the feasibility and acceptability of a single-session Acceptance and Commitment Therapy intervention to help women manage fear of childbirth during a first pregnancy.

Design

A mixed-methods approach including qualitative feedback and pre/post-intervention self-report measures. Pregnant women (14-37 weeks gestation) were recruited via the UK National Health Service and attended a single-session (<3 hours) Acceptance and Commitment Therapy intervention alongside routine antenatal care. Data were analysed using content and statistical analyses.

Main outcome measures

Fear of childbirth, anxiety and wellbeing were the main outcome measures. Secondary to these, intolerance of uncertainty and valued life domains (e.g. relationships, recreation) as hypothesised mechanisms of change, were also assessed.

Results

33 expressions of interest were received, 21 women signed up, 15 participated, and 11 completed follow-up measures (participation rate: 33%). Findings demonstrated clinical and statistical reductions in fear of childbirth and anxiety alongside positive feedback on the intervention. Intolerance of uncertainty and wellbeing were low at baseline and remained unchanged.

Conclusion

A single-session Acceptance and Commitment Therapy intervention to manage fear of childbirth is potentially feasible and acceptable. A pilot randomised controlled trial is warranted. Further research should explore efficacy and how Acceptance and Commitment Therapy may reduce perinatal distress.

Keywords:

• Pregnancy
• fear of childbirth
• intolerance of uncertainty
• psychological intervention

Introduction

Fear of childbirth (FOC)

Some worries about childbirth, particularly among women having their first baby, can be considered normal; however, a recent meta-analysis estimated 14% of women worldwide experience significant fear of childbirth (O’Connell et al., 2017). FOC can have wide reaching implications for women, babies, and healthcare services, including increased healthcare usage (Andersson et al., 2004), elective caesarean sections (Waldenström et al., 2006) and a priori requests of epidural analgesia (Van den Bussche et al., 2007), as well as negative experiences of childbirth, birth trauma, lower rates of breastfeeding, and greater risk of postnatal depression and post-traumatic stress disorder (Ayers & Ford, 2016; Veringa et al., 2016).

Research also suggests that women with FOC receive significantly more psychotropic medication (Nordeng et al., 2012), experience greater difficulties with attachment to their baby (NHS London Clinical Networks, National Health Service (NHS) London Clinical Networks, 2018), and are more likely to delay or not become pregnant again (Sydsjö et al., 2013). Exposure to maternal distress both in utero and post-birth can also negatively affect babies’ development (Schetter & Tanner, 2012). Both antenatal depression and anxiety are associated with an increased risk of emotion regulation difficulties (Glasheen et al., 2010; Leis et al., 2014) and social behaviour problems among children (Field, 2010). Evidence also suggests that adverse perinatal mental health outcomes impact children’s cognitive development (Evans et al., 2012) and may contribute to poor growth (Lampard et al., 2014).

To measure FOC effectively, Sheen and Slade (2018) carried out a meta-synthesis to identify the key constructs underpinning women’s fears. Women described fears of the unknown, potential for injury, pain, concerns about their body’s capacity to give birth, losing control and limited support from care providers (Sheen & Slade, 2018). The single overarching theme linking these six elements was ‘the unpredictability of childbirth’, with the mechanism best understood to drive FOC being intolerance of uncertainty (IOU). Using a quantitative approach, Rondung et al. (2019) also found that IOU was a significant predictor of FOC alongside pain catastrophizing. IOU is best described as a type of cognitive bias which affects how a person perceives and interprets uncertain situations. It can affect how a person responds to uncertainty at a cognitive, emotional, and behavioural level (Robichaud & Dugas, 2012). Subsequently, IOU can lead to control seeking and/or avoiding difficult emotions, thoughts, and sensations (Birrell et al., 2011).

Currently, maternity care pathways in the United Kingdom do not require assessment of childbirth fears (Richens et al., 2015). Guidelines only recommend enquiring about anxiety and depression (National Institute for Health and Care Excellence [NICE], 2014). A survey carried out by O’Brien et al. (2017) found that women with FOC received varying levels of antenatal care within England. The provision of support differed as some Trusts offered collaborative perinatal mental health team input whereas others referred to external providers. Similarly, some Trusts offered midwifery and/or obstetric support only and not all these practitioners were in receipt of mental health training for FOC. Several contributing factors for this variation in care were recognised, including a lack of integration between Maternity and Psychiatric/Psychology disciplines and limited funds being allocated to perinatal mental health.

Psychological interventions for FOC

Given the wide-ranging negative implications of FOC, effective interventions are needed but evidence for their effectiveness is limited. In Finland, a psychologist-led randomised control trial (RCT) of six group-based psychoeducation and relaxation sessions, found the intervention group reported more vaginal births, less fear, and fewer medical interventions. Cost savings of reduced medical interventions counterbalanced the group’s expense (Rouhe et al., 2015) and thus no additional expense was incurred.

In a small study, Nieminen et al. (2016) investigated the effects of internet-based cognitive behavioural therapy (I-CBT) for FOC (cohort study; n = 24). Their individual programme offered eight-weekly modules of guided self-help and therapy from a CBT practitioner, alongside 2-3 hours of homework per week. A significant decrease in women’s levels of FOC was reported during treatment (week 3 onwards) which remained at three-month follow-up.

In another study, Larsson et al. (2015) investigated the effect of counselling on FOC. Despite counselling sessions in Sweden being offered as standard care for women with FOC, guidelines for delivery were limited, with the main recommendation being that sessions should be led by maternity staff. Although not systematically evaluated, the study findings suggested that most women reported a degree of satisfaction following the counselling intervention (n = 56/70); however, counselling may be ineffective in reducing FOC in the long-term, as at one-year follow-up some women (n = 24/59) still experienced a ‘great deal’ of FOC.

Byrne et al. (2014) suggested that Mindfulness-Based Childbirth Education (MBCE) is acceptable and helpful for pregnant women as it provides skills-based education and mindfulness practices to improve emotional functioning and wellbeing in pregnancy, during birth, and early parenting. Additional studies have also suggested that pregnant women have benefited from ‘mind-body’ interventions such as yoga and hypnotherapy (Ryan, 2013).

A review by Striebich et al. (2018) highlights relatively limited evidence for psychological interventions and calls for the evaluation of theory-based interventions based on cognitive factors for overcoming fear. In addition, the resource constraints of providing multiple sessions emphasises the need for the evaluation of less intensive, and therefore less costly, interventions that may be easier to implement in the healthcare system. A recent expert consensus statement concerning FOC also called for research into psychological interventions as a priority (Jomeen et al., 2021).

Acceptance and commitment therapy (ACT)

ACT is a third-wave cognitive behavioural therapy that focuses on an individual’s relationship to their thoughts and emotions rather than content and thinking styles (Hayes & Hofmann, 2017). It aims to foster ‘psychological flexibility’ which can be understood as one’s ability to be in contact with the present moment, as a conscious human being, to be open to experiences and to change or continue in value-driven behaviour (Hayes et al., 2011). ACT offers techniques such as mindfulness skills with the practice of self-acceptance to help individuals relate to difficult thoughts and emotions in more helpful ways. This is further facilitated by committing to actions that help to facilitate experience and embrace challenges (rather than to avoid). Due to its trans-diagnostic approach, ACT has been highlighted to be well placed to meet the needs of women with physical and/or mental health difficulties during the perinatal period (Bonacquisti et al., 2017); however, to our knowledge, there are no published studies exploring the use of ACT for FOC during first pregnancy.

ACT also provides an alternative approach for addressing IOU. ACT proposes a courageous willingness (also referred to as acceptance) to be present with feelings of uncertainty during pregnancy, combined with committed actions aimed at living a rich and meaningful life via valued activity (Hayes & Smith, 2005). Greater levels of acceptance have been found to be related to improved adjustment and quality of life (Pakenham & Fleming, 2011). Furthermore, a meta-analysis indicates potential effectiveness of ACT for a range of difficulties, including anxiety, depression, addiction, and somatic health difficulties (A-Tjak et al., 2015).

Single-session therapy (SST)

Given the imperative for a brief effective intervention and the potential relevance of ACT in the context of FOC, a key question is whether a single-session group version could be developed and whether this would be feasible and acceptable to women in the maternity setting. Talmon (1990) suggests that the modal number of sessions (across a range of psychological therapies and settings) most patients attend is one, with 70–80% of individuals reporting satisfaction with outcomes. The goal of SST is not to ‘cure’ in a single-session but to offer solutions to harness clients’ strengths and autonomy in implementing immediate change. Brief interventions to prevent or reduce perinatal mental distress are in keeping with the Long-Term Plan (NHS England, 2019) which emphasises empowering people to manage their own health and wellbeing.

Aim and objectives

The main aim of this study was to assess the acceptability of a single-session ACT intervention to reduce FOC and worry reported by women coping with the uncertainties of childbirth in a first pregnancy. Elements of feasibility were also examined by reviewing recruitment and retention data, as well as the assessment of outcomes to detect preliminary treatment signals.

Feasibility and acceptability objectives (Table 1) were developed using the PICO framework (Richardson et al., 1995) and recommendations from Eldridge et al. (2016). This approach is consistent with the scope of other feasibility studies (National Institute of Health Research [NIHR], 2015). Indicators of acceptability were guided by elements of Sekhon et al. (2017) Theoretical Framework of Acceptability (TFA), specifically affective attitude, burden, ethicality, intervention coherence and perceived effectiveness.

Table 1. Feasibility and acceptability objectives as per the PICO framework (Richardson et al., 1995).

Criteria	Determinants	Ascertainment
Population	Could a group of eligible women (N = 36) wanting psychological input to manage their uncertainties around childbirth during first pregnancy be recruited and retained.	a) Whether women expecting their first baby were recruited; b) whether women consented to participate; c) whether midwives referred.
Intervention	Whether a single ACT session is acceptable to this population.	a) Acceptability refers to how well this approach was received and how well it met the needs of the sample; b) attendance rates; c) evaluation form feedback
Control	Study not controlled. It was intended to determine the viability of conducting a future pilot-RCT.
Outcomes	Could suitable measures be identified to explore reductions in FOC, worry and psychological distress as well as any potential increases in IOU and value driven behaviour.	a) Utility of outcome measure standard deviations; b) estimation of sample size; c) identification of any preliminary treatment signals between pre-post follow up scores

Method

Ethics and study design

University of Liverpool Sponsorship (UoL001437), NHS ethics (19/LO0269) and Health Research Authority (HRA) approval were granted prior to data collection. A mixed-methods approach was used, including simple process evaluation via qualitative feedback and quantitative information via standardised outcome measures.

Development of ACT session materials

Bespoke ACT session materials were based on a guide to ACT delivery for professionals (Harris, 2009) with input from Association of Contextual Behavioural Science (ACBS) ACT Peer-Reviewed Trainer (RW) and perinatal Consultant Clinical Psychologist (PS). Materials included a ‘coping with the uncertainties of childbirth’ presentation and a self-help tool kit modelled on the ‘be present, be open and do what matters’ approach (Hayes et al., 2011). The materials were developed in partnership with experts by experience, recruited through the Hospital’s Maternity Voices Partnership¹. The finalised content met the key elements of ACT whilst being shaped for the pregnancy context.

The materials provided women with ACT-informed psychoeducation, mindfulness practice, observing-self exercises, and opportunities to identify and commit to value-driven behaviour as well as creating space for self-reflection. Women were invited to hold in mind what prompted them to attend the session and to reflect upon the information presented using their own experiences. A facilitator session plan was also developed which detailed out the practical arrangements for delivery.

Participants

Inclusion Criteria: Women were eligible if they were in receipt of care from the hospital with their first baby, had a single pregnancy, were between 11-38 weeks pregnant, aged 18 years and over, and had a good understanding of English. Exclusion criteria: known medical complications affecting pregnancy/birth status, or women who were being supported by the perinatal mental health team.

The study aimed to recruit 36 women, with an anticipated loss to follow-up rate of 25%. Other FOC and ACT feasibility and/or pilot studies have included participant samples ranging from 12 (Saracutu et al., 2018) to 28 (Nieminen et al., 2016).

Setting and recruitment

Expression of interest forms (EOI) were distributed to 79 community midwives within a tertiary care maternity hospital, in the North-West of England. Women who self-reported FOC, were to be identified by their midwife. No formal screening of FOC was required. Women who were eligible, completed the ‘EOI and consent to contact’ slip and returned this to their midwife, who passed this onto the researcher. The EOI form was also advertised on the hospital’s social media accounts every fortnight between July and December 2019. Women could self-refer by contacting the researcher; with their eligibility being confirmed by the midwives. The researcher then invited eligible women to attend an ACT session convenient for their schedule.

Procedure

Women attended a single-session ACT intervention lasting up to 3 hours. The single-session was delivered in-person, on seven separate occasions, on weekday evenings at the maternity hospital, between July and December 2019. The session was made available to a maximum of 12 women per session (accompanied by a guest if they wished). If only one woman signed up, the session still went ahead.

After introductions and formal consent, women completed questionnaires covering both emotional aspects (FOC, anxiety and wellbeing) and potential mechanisms of change (IOU and values). The researcher then guided women through the ACT presentation, with support from the Consultant Midwife. Throughout, time was provided for embedded experiential learning exercises, opportunities for questions and for women to share reflections (as wished). Time was also offered to discuss the application of ACT skills into women’s daily lives. To finish, women were debriefed and evaluation forms were completed. Women were provided with a copy of the presentation and self-help tool kit. If requested, the Consultant Midwife offered women further support. Two weeks post-session, women were contacted to repeat the outcome measures.

Main outcome measures

Demographic and obstetric information

Information concerning age, ethnicity, marital status, education level and pre-pregnancy employment status and gestational stage was gathered.

Fear of birth scale (FOBS; Haines et al., 2011)

Women rated how they felt about birth using a two-item visual analogue scale, regarding the constructs of worry and fear. Women rated ‘‘how do you feel right now about the approaching birth,’’ using a range of ‘calm/worried’ and ‘no fear/strong fear’ on two 100 mm scales. The two values are averaged to form one score. The cut-off to identify fear of childbirth is 50. The FOBS has proven to be a valid measure for assessing FOC in antenatal contexts with 89% sensitivity and 79% specificity. This scale has demonstrated high internal consistency (α= .91; Haines et al., 2011). Internal consistency was high in the current study (α= .93).

The world health organization well-being index (WHO-5, 1998)

Women rated their current (previous two weeks) subjective psychological wellbeing on a five-item scale. The scale ranges from 0 (at no time) to 5 (all the time). Total scores range from ‘0-25′. Higher scores indicate greater wellbeing and quality of life. Topp et al. (2015) evidenced the WHO-5 having sufficient validity as a screen for depression and as an outcome measure, with a cut-off score of ≤50. A 10% difference in scores indicates a significant change to wellbeing (Ware & Davies, 1995). The scale has demonstrated good internal consistency for the assessment of maternal wellbeing (α= .85; Mortazavi et al., 2015). In the current study internal consistency was poor (α= .50).

Generalized anxiety disorder scale (GAD-7; Spitzer et al., 2006)

The GAD-7 is a seven-item questionnaire, which measures anxiety levels during the past two weeks. The scale ranges from 0 (not at all) to 3 (nearly every day). Total scores range from ‘0-21′. Higher scores indicate increased symptom severity. A score of >10 represents clinical levels of anxiety. Sensitivity is 89% and specificity 82% (Spitzer et al., 2006). The scale has demonstrated good internal consistency among pregnant women (α= .89; Zhong et al., 2015). Internal consistency was good in the current study (α= .81).

Intolerance of uncertainty scale (IUS-12; Carleton et al., 2007)

The IUS-12 is a 12 item self-report tool which measures responses to uncertainty, ambiguous situations and the future using a five-point Likert scale. The scale ranges from 1 (not characteristic of me) to 5 (entirely characteristic). Total scores range from 12-60, with higher scores indicating greater difficulty tolerating uncertainty. Scores ≥35 represent significant IOU. IUS-12 has demonstrated good convergent and discriminant validity, as well as internal consistency (α = .85; Carleton et al., 2007). In the current study internal consistency was good (α= .85).

Valued living questionnaire (VLQ: Wilson & Groom, 2002)

The VLQ is a two-part questionnaire that measures valued living, which is a core process of ACT (Wilson et al., 2010). Firstly, women were required to rate their levels of importance of 10 life domains using a 1-10 scale. Secondly, using the same scale they were asked to rate the extent to which they had been living consistently with these values. Higher scores indicate higher levels of importance and value driven behaviour. Life domains include; Family, Marriage/Couples/Intimate relations, Parenting, Friendship, Work, Education, Recreation, Spirituality, Citizenship and Physical Self-Care. A total score is calculated for both importance and consistency (10-100). The measure has demonstrated adequate internal consistency (α= .74; Wilson et al., 2010). In the current study, the internal consistency was adequate on the importance subscale (α= .67) and good on the consistency subscale (α = .83).

ACT-session evaluation form

A bespoke feedback form was developed. Feedback was sought regarding clarity, organisation, interest, and usefulness of the single-session ACT intervention via a Likert scale ranging from 0 (not at all) to 10 (extremely). The Likert scale was also used to ascertain how clearly the ACT elements (‘be present, be open, do what matters’) were explained. Women were asked to tick which strategies appealed and to rate how confident they felt about using the skills and self-help tool kit. Qualitative feedback sought suggestions for improvement and other comments.

Data analysis

As this was a feasibility study no formal power calculation was completed. Data analysis was performed using SPSS v.25. Datasets from four women were omitted from the main inferential analyses due to non-completion of follow-up measures. Due to the small sample size and normality assumptions not being met, non-parametric tests were used. Descriptive statistics and the Wilcoxon Signed-Rank test were conducted to perform within-group analyses between pre-session and post-two-week outcomes. Hedges’ g was performed to measure effect size; a large effect is determined by a score ≥ 0.8.

Individual’s pre- and post-intervention data were also considered using the Reliable Change Index and Clinically Significant Change analysis. These analyses were both reported using Jacobson and Truax’s (1991) methodology using cut-off b (following the ACT session women’s levels of functioning should fall within the range of the normal population; the range beginning at two SD below the normal population mean).

Descriptive statistics were performed to analyse the evaluation form data. Latent content analysis was performed by hand using Microsoft Word (due to the small amount of data), to discover and interpret underlying meanings in women’s qualitative feedback (Hsieh & Shannon, 2005). The researcher immersed themselves in the data, conducting several readings of the text. Sentences were then progressively divided into smaller units, phrases and fragments. The initial coding scheme (defined by the research question) emerged from the data (Hsieh & Shannon, 2005). Codes were verified, consolidated and quantified during supervision (PS). Table 2 shows the extracted codes alongside descriptions and quotes.

Table 2. Content analysis of Acceptance and Commitment Therapy (ACT) evaluation form (N = 15).

Recommendations
Content (code)	Description	Quotes	Frequency
No suggested improvements	No changes required	‘I don’t think anything needs to be improved’	1
Birth plans	Include more information aboutthe contextual factors affectingbirth	‘More emphasis on birth and birthing worries rather than being general sessions would be great’.	1
Other Comments
Techniques/Skills	The learning of new techniques	‘Pleased to learn some new skills’’The mindfulness and observing parts were really helpful’	9
Helpful	The session/information being helpful	‘It was very helpful’’…I feel like I can take away a lot …’	7
Accessible	The session/information being user friendly	‘Clear and well explained’’The right amount of information made it comfortable to process’	6
Intention	An intention to use the information	‘I will definitely use these to cope’’… I will use the methods discussed to help this’	5
Pregnancy/Childbirth	The information being helpful for pregnancy/childbirth worries	‘Useful tools for people with pregnancy fears and uncertainties’’…Hopefully [I will] use the techniques during labour’	4
Gratitude	Thankfulness	‘Thank you very much’	2
Enjoyment	Pleasure and satisfaction	‘I really enjoyed the session and it’s delivery’	2
Generalisability	The information being generalisable	‘Pleased to learn some new skills to apply to life in general as well as during childbirth’	2
Relaxing	Reduced arousal	‘I found the session very relaxing …’	1

Results

Recruitment and attendance

In response to the study advertisement 33 expressions of interest were received with 21 women signing up to attend. Fifteen women participated, and 11 completed follow-up assessments (study participation rate: 33%). Thirteen out of 22 women (59%) referred by their midwife did not attend in comparison to five women (45%) who self-referred. Reasons for not attending included; ‘not stated’ (10), work (4), gave birth (1), miscarriage (1), family bereavement (1) and feeling okay about birth (1). There was no significant difference between the different referral groups in non-attendance rates (p = .49; Fisher’s Exact Test).

Participants

As shown in Table 3, the mean age of the attenders was 30.3 (SD = 6.03) years, and the mean pre-session gestation was 30.3 (SD = 4.99) weeks. The age of women and the proportion of women who were of White-British ethnicity, were comparable to English antenatal data (The Office of National Statistics, 2011, 2017).

Table 3. Womens’ characteristics (N = 15).

	Range		Mean (SD)		Normative mean
Age of first pregnancy (years)^b	20-40		30.3 (6.03)		28.8
			Total, n (%)		%
Marital Status^c
Married			5 (33.3)		50.5
In a relationship			7 (46.7)		10.4
Single			3 (20.0)		35.0
Educational attainment^e
Low education (no qualifications/GCSEs)			0 (0)		51.3
Mid education (A Levels / Vocational)			2 (13.3)		21.6
High education (graduate/post-graduate)			13 (86.6)		27.2
Pre-pregnancy employment^d
Employed (full time/part time)			14 (93.3)		72.3
Unemployed (out of work/student/ voluntary)			1 (6.7)		27.7
Ethnic Origin^f
White British			13 (86.7)		85.4
White Other			1 (6.7)		4.6
Mixed Other			1 (6.7)		0.8
	Range		Mean (SD)		–
	Pre-session	Follow-up (>2weeks)	Pre-session	Follow up- (>2weeks)^g
Gestation (weeks)	17-36	19-39	30.3 (4.99)	32.5 (5.32)

^bThe Office of National Statistics (2017).

^cThe Office of National Statistics (2018).

^d,fThe Office of National Statistics (2011).

^eThe Office of National Statistics (2020).

^gn = 10 (1-woman completion date unknown).

ACT session feedback

Feedback was very positive with women rating the objectives of the session as extremely clear (Mdn = 10, IQR =0.5), they considered it to be extremely well organised (Mdn = 10, IQR= 0.5) and they found it both extremely interesting (Mdn = 10, IQR = 0.5) and useful (Mdn = 10, IQR = 1). As shown in Table 4, all 15 women reported an interest in at least one of the ACT strategy domains (mindfulness/being present, observing self/being open, value driven behaviour/do what matters). A third of the women (n = 5) reported an interest in all three. Women also rated high levels of confidence regarding how applying the ACT techniques into their daily lives (Mdn = 9, IQR = 1.5) and about their proposed use of the self-help tool kit (Mdn = 10, IQR = 2).

Table 4. Acceptance & Commitment Therapy (ACT) strategies which appealed to women (N = 15).

Which ACT Strategies appealed the most?	Number of Women	%
Value driven behaviours	1	6.70
Mindfulness & Value driven behaviours	1	6.70
Mindfulness & Observing self	4	26.7
Observing self & Value driven behaviours	4	26.7
Mindfulness, Observing self & Value driven behaviours	5	33.3

Eleven themes were coded following content analysis: ‘No Suggested Improvements’, ‘Birth Plans’, ‘Techniques and Skills’, ‘Helpful’, ‘Accessible’, ‘Intention’, ‘Pregnancy and Childbirth’, ‘Gratitude’, ‘Enjoyment’, ‘Generalisability’ and ‘Relaxing’. Table 2 shows the analysis of the evaluation form feedback (n = 15). Additional feedback was voluntarily offered from six women, during post-follow-up contact. This was also very positive, with women referencing gratitude for being able to attend as well as the ACT techniques being helpful for coping with birth related worries pre and during labour.

Preliminary treatment signals

Eight (73%) out of 11 women reported clinical levels of FOC at baseline with four (36%) women still reporting clinical levels at follow-up. Six (55%) of 11 women reported at least ‘moderate’ (>10) levels of anxiety at baseline, with three (27%) still reporting such levels at follow-up. Nine (82%) of 11 women had wellbeing scores ≤50. Three (27%) women had IOU scores of ≥35 before the session, with no reported change at follow-up. Table 5 provides descriptive data for both 15 and 11 women at baseline and 11 women only at follow-up.

Table 5. Pre- and post-session descriptive statistics.

	Pre-session scores of women who attended (n = 15)			Pre-session scores of women who attended and completed follow-up (n = 11)			Post-session scores of women who attended and completed >2-week follow-up (n = 11)
Variable	Mean (SD)	Median	IQR	Mean (SD)	Median	IQR	Mean (SD)	Median	IQR	Possible Range
Fear of Birth (FOBS)
Calm-Worried	61.1 (21.5)	67	38	61.7 (18.5)	66	38	40.0 (22.5)	30	38	0-100
No Fear - Fear	64.3 (23.6)	70	32	68.2 (21.2)	70	35	47.4 (23.9)	43	38	0-100
Average score	62.9 (22.0)	70	37	65.2 (19.4)	69	37	44.0 (22.2)	34	38	0-100
Anxiety Symptoms (GAD-7)	11.1 (4.85)	11	9	11.6 (5.07)	11	10	8.18 (3.49)	8	5	0-21
How difficult have symptoms made daily life	1.07 (0.80)	1	0	1 (0.63)	1	0	0.82 (0.87)	1	1	0-3
Wellbeing (WHO-5)	43.5 (11.9)	40	20	43.6 (9.17)	40	12	44.2 (12.8)	44	10	0-100
Intolerance of Uncertainty (IUS-12)
Prospective uncertainty	20.2 (6.80)	22	9	20.0 (6.65)	19	8	19.2 (6.88)	17	12	7-35
Inhibitory uncertainty	11.3 (4.85)	10	8	11.1 (3.96)	10	6	9.45 (3.56)	9	6	5-25
Total Score	32.2 (10.7)	31	16	32.0 (9.63)	31	10	28.6 (10.2)	25	10	12-60
Values Importance (VLQ)
Family	9.07 (1.44)	10	2	8.73 (1.56)	10	3	8.91 (1.51)	9	2	1-10
Marriage/Intimate relations	9.20 (1.74)	10	1	8.91 (1.97)	10	1	8.64 (2.34)	10	3	1-10
Parenting	9.47 (0.74)	10	1	9.36 (.81)	10	1	9.36 (1.57)	10	0	1-10
Friends/Social life	8.27 (1.44)	9	2	8.73 (1.19)	9	2	8.91 (1.38)	9	2	1-10
Work	7.67 (1.45)	8	3	7.82 (1.17)	8	2	7.36 (1.43)	7	2	1-10
Education	7.87 (1.96)	8	2	8.36 (1.50)	8	2	7.73 (2.10)	8	2	1-10

Table 5. Continued.

	Pre-session scores of women who attended (n = 15)			Pre-session scores of women who attended and completed follow-up (n = 11)			Post-session scores of women who attended and completed >2-week follow-up (n = 11)
Variable	Mean (SD)	Median	IQR	Mean (SD)	Median	IQR	Mean (SD)	Median	IQR	Possible Range
Recreation/Fun	7.93 (1.71)	8	2	8.18 (1.60)	8	3	8.09 (1.81)	8	2	1-10
Spirituality	5.53 (2.90)	5	5	5.91 (3.27)	6	7	6.00 (3.19)	6	6	1-10
Citizenship	5.53 (2.88)	5	5	6.45 (2.73)	6	4	6.45 (1.75)	7	3	1-10
Physical self-care	7.87 (2.23)	8	3	8.36 (1.80)	8	2	8.27 (1.27)	8	2	1-10
Importance Total	78.1 (9.99)	77	17	80.8 (10.1)	79	15	79.7 (9.01)	78	20	10-100
Work	5.00 (3.14)	6	7	4.64 (3.33)	6	6	4.91 (3.02)	6	6	1-10
Education	4.64 (3.61)	5	7	4.73 (3.66)	6	7	5.27 (2.80)	6	4	1-10
Recreation/Fun	5.57 (2.44)	6	4	5.64 (2.11)	6	3	6.09 (2.17)	7	3	1-10
Spirituality	4.43 (2.98)	4	5	4.36 (2.66)	4	4	5.91 (3.33)	6	7	1-10
Citizenship	4.29 (2.87)	4	5	4.18 (2.48)	5	4	4.82 (2.36)	5	4	1-10
Physical self-care	4.57 (2.93)	4	4	4.91 (3.05)	5	6	6.09 (2.43)	6	4	1-10
Consistency Total	56.9 (18.2)	58	23	55.7 (18.2)	61	26	63.3 (14.0)	63	21	10-100

Note: FOBS; Fear of Birth Scale; GAD-7; Generalized Anxiety Disorder-7; WHO-5; World Health Organisation five wellbeing index; IUS-12; Intolerance of Uncertainty Scale-12; VLQ; Valued Living Questionnaire.

The Wilcoxon Matched-Pairs Signed-Ranks test; Pre-Post session (n = 11)

Women’s pre-session and two-week follow-up fear of birth scores were compared. Median levels of FOC were lower at follow-up (Mdn = 34, IQR = 38) than baseline (Mdn = 69, IQR = 37) (Wilcoxon signed-rank test, Z= −2.49, p= .01). Median anxiety scores were also significantly lower at follow-up (Mdn = 8, IQR = 5) than baseline (Mdn = 11, IQR = 10) (Wilcoxon signed-rank test, Z= −2.41, p= .02.). No other significant differences were found (Table 6). Hedges’ g suggests large effect sizes for FOC and anxiety (FOBS: 1.02 and GAD-7: .79).

Table 6. Results of within-group analysis comparing women’s pre & post session outcomes.

Measures	Z-score	p-value	Effect Size (g)	95% Confidence Interval
FOBS	−2.49	.01*	1.02	−38.0, − 5.00
GAD-7	−2.41	.02*	.	−7.00, −.50
WHO-5	.15	.88	.05	−4.00, 6.00
IUS-12	−1.56	.12	.34	−7.50, 1.00
VLQ importance	.15	.88	.10	−8.50, 4.50
VLQ consistency	1.20	.23	.47	−5.00, 19.0

n = 11; p ≤ 0.05.

Non-parametric test; medians analysed.

Note: FOBS; Fear of Birth Scale; GAD-7; Generalized Anxiety Disorder-7; WHO-5;.

World Health Organisation five wellbeing index; IUS-12; Intolerance of Uncertainty Scale-12; VLQ; Valued Living Questionnaire.

Sample size calculation for a future trial

To detect a statistically significant difference in mean scores using the FOBS (Haines et al., 2011) in a future RCT, assuming a large effect size, a minimum of 10 women are needed in each of the control and experimental groups (p=.05, power 90%); however, it must be noted this is based on within-group analysis and therefore non-controlled comparisons only.

Reliable change index (RCI) and clinically significant change (CSC)

To identify individual impact, Table 7 illustrates the degree of reliable and clinically significant change for each of the pre-post measures for the 11 women. Overall, there were reliable and clinical improvements for six women regarding their levels of childbirth fear (FOBS; Haines et al., 2011) and anxiety (GAD-7; Spitzer et al., 2006). Along with two women having a reliable increase in their value driven behaviour (VLQ; Wilson & Groom, 2002). This was clinically significant for one of them.

Table 7. Reliable Change Index (RCI) and Clinically Significant Change (CSC) for pre-post outcome measures (N = 11).

Variable	Pre-session mean (SD)	Post-session mean (SD)	Reliability Co-efficient (α)	Normative Mean (SD)	RCI	No change, n, (%)	Improved, n, (%)	Deteriorated, n, (%)	CSC, n, (%)
FOBS	65.2 (19.4)	44.0 (22.2)	.91^h	41.0^i (21.0)	16.6	5 (45.5)	6 (54.5)	–	6 (54.5)
GAD-7	11.06 (5.07)	8.15 (3.49)	.89^j	3.20^k (3.50)	6.12	9 (81.8)	2 (18.1)	–	2 (18.1)
WHO-5	43.6 (9.17)	44.2 (12.8)	.85^l	59.8^m (20.2)	10.4	8 (72.7)	2 (18.1)	1 (9.09)	0 (0)
IUS-12	32.0 (9.63)	28.6 (10.2)	.85^n	49.9^o (17.2)	10.4	11 (100)	–	–	0 (0)
VLQ-imp	80.8 (10.1)	79.7 (9.01)	.74^p	87.2^q (8.69)	14.3	10 (90.9)	–	1 (9.09)	0 (0)
VLQ-cons	55.7 (18.2)	63.3 (14.0)	.74^l	87.2^m (8.69)	25.7	9 (81.8)	2 (18.1)	–	1 (9.09)

^h,cHaines et al. (2011).

^jZhong et al. (2015).

^kLöwe et al. (2008).

^lMortazavi et al. (2015).

^mEllervik et al. (2014).

^n,iCarleton et al. (2007).

^l,mWilson and Groom (2002).

Discussion

Acceptability and feasibility of the single-session ACT intervention for supporting women with FOC during a first pregnancy, were explored via the analysis of quantitative outcomes (NIHR, 2015) alongside qualitative information regarding women’s views, experiences and recommendations (Sekhon et al., 2017). Preliminary information about treatment signals and possible mechanisms of change were also explored through analysis of quantitative measures at two time points. While the results should be interpreted with caution, given the lack of control group and small sample size, our quantitative findings indicate significant reductions in women’s levels of FOC and anxiety alongside increased value-driven behaviour after participation in a single-session ACT intervention delivered during pregnancy. The qualitative data highlights that women’s attitudes towards the ACT session were very positive, with techniques and concepts being described as ‘extremely helpful’. Women also reported a high likelihood of continued engagement with the intervention in their daily lives.

Recruitment was facilitated by women being able to self-refer as well as being signposted by their midwives. The sample size is smaller than anticipated but it is similar to that of Saracutu et al. (2018) feasibility study which used a brief ACT intervention for pain. Around half of the women expressing an interest in the ACT session attended and for the majority of non-attenders, a reason was not reported. Although non-significant, a greater drop-out of women occurred following a midwifery referral in comparison to women who self-referred.

Few studies have reported what might be considered ‘good’ uptake levels within the perinatal context. However, it is well recognised that there are barriers or perceived burden associated with engaging with support for mental health difficulties in the perinatal phase, not least stigmatization and fears of being labelled as a ‘bad mother’ (Viveiros & Darling, 2019). It is of interest that the current study’s attendance rate is consistent with a retrospective review by Albaugh et al. (2018), which demonstrated only 50% of women who were pregnant or had given birth in the last year who were referred for mental-health related support, attended their initial appointment.

Lacy et al. (2004) explored no-show rates and the possible reasons why adult clients with a range of presenting difficulties, failed to attend 1:1 outpatient psychotherapy appointments. Their findings suggest that negative emotions about the appointment can override any perceived benefits. A delay between scheduling and attendance also contributed to this dynamic. Subsequently, fear and worry presented as emotional barriers to attendance. This may be particularly pertinent for women who may already be experiencing high levels of worry and fear about birth.

The Theory of Planned Behaviour (TPB) is a useful framework for understanding motivation to attend appointments (Sheeran et al., 2007). According to the TPB, an important predictor of behaviour is one’s intention to perform it. Intentions are thought to represent the motivational factors that influence behaviour, and thus direct how much effort is invested into performing the action (Ajzen, 1991). Sheeran et al. (2007) showed that by implementing an intention formation (‘if-then plan’ based on normalising anticipated negative affect) participants in a non-perinatal sample were able to self-regulate, which subsequently helped them to attend their initial psychotherapy appointments.

In terms of women’s affective attitudes, perceived effectiveness and ethicality, the ACT session was experienced very positively in terms of it being helpful and it was consensually deemed to be user-friendly. Women engaged with the content and they reported high levels of self-efficacy as they felt equipped to take at least one of the strategies forward in their daily lives. Women also expressed gratitude for being offered help to manage their birthing worries. Additional feedback post-follow-up also highlighted women’s gratitude. One lady shared that she had even benefited from applying the ACT techniques during her labour. Intervention coherence was therefore demonstrated as it had face validity for women.

The results show statistically significant reductions in FOC and anxiety with large effect sizes and positive patterns of clinically significant change. Despite the large effect size demonstrated from within-group comparisons here, it is more typical to assume a moderate effect size and to utilise between-group (intervention versus control) effect sizes. In order to provide this information, a pilot randomised controlled study is required. The internal consistency for the WHO-5 (1998) in this study was poor. This may be due to the small sample and/or inadequate correlation of items. The WHO-5 has previously shown good internal consistency in antenatal samples (Mortazavi et al., 2015).

A proportion of the changes to FOC, anxiety and valued living were also deemed reliable and clinically meaningful. Importantly there were no indications of the intervention leading to adverse outcomes. Also ‘no change’ does not mean the support offered was ineffective. The intervention may have prevented an escalation of distress, as the literature highlights FOC to typically increase over time (Hofberg & Ward, 2007), which was not demonstrated at follow-up for this sample.

Despite these findings, there were no changes to IOU. At baseline, only three women reported clinical levels of IOU and these remained. This is important theoretically as it suggests that either the IUS-12 (Carleton et al., 2007) ineffectively captured women’s levels of IOU, or other processes underpin FOC. However, findings demonstrate increased levels of value-driven behaviour, which is a key process of ACT. Although, no significant changes were shown regarding the level of importance placed by women on valued life domains. This may be due to inadequate internal consistency or that this ACT process may not be sensitive to change during a small (> 2-week) time-frame.

ACT aims to increase psychological flexibility through process of change captured within the ‘be present, be open, do what matters’ approach. Avoidant coping was not directly tested, but future studies should examine whether ACT helps women minimise avoidant coping styles, through the development of a courageous willingness to be present with feelings of childbirth related worry and fear alongside a commitment to value-driven behaviour. With the development of greater levels of courageous willingness, women may be more open to the uncertainties of childbirth. Future studies could therefore explore the role of psychological flexibility and include the Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011) as a measuring tool.

An important consideration is that participants were on average already 30.3 weeks gestation. This may be a function of service provision in that there is currently no systematic way of identifying high levels of FOC in antenatal provisions in England. The guidelines only recommend enquiring about anxiety and depression (NICE, 2014). Implementing health related behaviour change also takes time and with any skill, practice is important (Gardner et al., 2012). This has implications for interventions offered in pregnancy, as there may well be unknown opportunity costs (the extent to which benefits, profits, or values must be given up to engage in an intervention).

Whilst accessing support later on in pregnancy is consistent with previous research, studies suggest that fear increases during the third trimester (Hofberg & Ward, 2007) and developmentally for the foetus, this is potentially too late in terms of offering interventions. The prenatal period is a critical and vulnerable time for foetal neurodevelopment. During this time, a range of exposures (including maternal distress) have been shown to contribute towards long-term changes to foetal development, with adverse longer-term implications for physical and mental health of the child (Kinsella & Monk, 2009). Subsequently for expectant mothers and their unborn babies, accessing support earlier on in the prenatal period is vital.

In summary, it appears that a single-session of ACT has the potential to be both feasible and acceptable for women with FOC in a first pregnancy and it warrants further testing. The next stage would be a pilot-RCT study. The prevalence of FOC may be increasing (O’Connell et al., 2017) which further enhances the salience of the current study. FOC has also been shown to be correlated with women’s positive attitudes towards obstetric interventions, as pain relief and caesarean sections on maternal request have increased globally (Mascarello et al., 2017).

Strengths and limitations

This study had several strengths including the ACT session being described as ‘coping with the uncertainties of childbirth’ on midwifery advice to reduce any potential stigma or being labelled as ‘not coping’ in pregnancy. The ACT intervention has shown to be potentially acceptable and feasible, with preliminary positive treatment signals. This is important considering the need for briefer, cheaper interventions within the healthcare system (Striebich et al., 2018). The findings also provide a useful benchmark as they indicate trends and themes that could be explored in a future trial. The mixed-methodological approach is also a strength. Alongside the materials being developed in liaison with RW, to ensure high-fidelity to the ACT model.

Limitations of the study included a specified level of FOC on a validated measure not being required for participation. Nevertheless all women self-identified as having FOC and had perceived difficulties with coping. Additionally, information about women’s usage and experience of the self-help toolkit was not sought. Future studies may benefit from seeking this information. The two-week follow-up period was also brief. Despite regular reminders to the community midwives and on social media, we do not know audience data and the reach of the EOI’s and advertisements. It is likely that engagement varied and not all women for whom this could be of benefit, were made aware. Women from diverse backgrounds were under-represented which limits generalisability. Bias may also have been introduced during data gathering, due to the researcher joint facilitating the session. This may have reduced women’s willingness to provide critical feedback. The internal consistency of the WHO-5 for this study was also poor (α= .50). The GAD-7 (Spitzer et al., 2006) was chosen as it relates to the GAD-2 (Kroenke et al., 2007) which is recommended by NICE (2014) for use routine antenatal care and is a reduction of the GAD-7. However, it could also have been informative to assess pregnancy specific anxiety.

Future research and clinical implications

Future research via a pilot-RCT could incorporate a FOC screen and explore whether changes in psychological flexibility (AAQ-II; Bond et al., 2011) via the ACT processes ‘be present, be open, do what matters’, reduce perinatal distress. The role and use of the self-help tool kit also merits evaluation alongside increasing the follow-up period to four weeks. A formal measure of ACT fidelity using the ACT-FM (O’Neil et al., 2019) should also be included. An economic evaluation of the intervention is similarly warranted as it has the potential to be cost-effective. Increased screening and more ecologically valid assessment of FOC and anxiety (Slade et al., 2019, 2021) during pregnancy may also help women and the professionals to become more aware of their needs and provide adequate support (Evans et al., 2017).

Conclusion

A single-session ACT intervention was shown to be potentially acceptable and feasible in supporting women cope with the uncertainties of childbirth in a first pregnancy. This study has demonstrated preliminary positive treatment signals, with reductions in FOC and anxiety alongside increased value-driven behaviour. It also raises an important theoretical question regarding whether IOU is the underlying mechanism. A pilot-RCT is warranted.

Reporting checklists

Not Applicable.

Acknowledgments

Thank you to all the women who participated and the midwives who facilitated this work.

Disclosure statement

No potential conflict of interest was reported by the authors.

Data availability statement

The data that support the findings of this study are available from the primary supervisor (PS), upon reasonable request, under University of Liverpool data management arrangements.

Additional information

Funding

This work was supported by the Doctorate of Clinical Psychology Training at the University of Liverpool (UoL001437).

Notes

1 A forum for maternity service users, providers, and commissioners to collaboratively design and input into maternity services, so they meet the needs of local women and families in the catchment area.