https://orcid.org/0009-0005-2510-2999
ABSTRACT
Objectives
Cognitive-behavioral stress management (CBSM) is an effective psychological intervention to relieve psychological and symptomatic distress. This study aimed to investigate the effect of CBSM in anxiety, depression, and post-traumatic stress disorder (PTSD) in parents of pediatric acute myeloid leukemia (AML) patients.
Methods
Totally, 56 pediatric AML patients and 100 parents were randomized into the CBSM group (28 patients and 49 parents) and the normal control (NC) group (28 patients and 51 parents) to receive corresponding interventions for 10 weeks. The questionnaire scores were assessed at month M0, M1, M3, and M6.
Results
In parents of pediatric AML patients, self-rating anxiety scale score at M1 (p = 0.034), M3 (p = 0.010), and M6 (p = 0.003), as well as anxiety at M3 (p = 0.036) and M6 (p = 0.012) were decreased in the CBSM group versus the NC group. Self-rating depression scale score at M3 (p = 0.022) and M6 (p = 0.002), as well as depression at M6 (p = 0.019) were declined in the CBSM group versus the NC group. Symptom checklist-90 (a psychotic status questionnaire) score at M3 (p = 0.031) and M6 (p = 0.019) were declined in the CBSM group versus the NC group. Regarding PTSD, the impact of the events scale-revised score at M3 (p = 0.044) and M6 (p = 0.010) were decreased in the CBSM group versus the NC group. By subgroup analyses CBSM (versus NC) improved all outcomes in parents with anxiety at M0 and depression at M0 (all p < 0.050), but could not affect the outcomes in parents without anxiety or depression at M0 (all p > 0.050).
Conclusion
CBSM reduces anxiety, depression, and PTSD in parents of pediatric AML patients.
Introduction
Acute myeloid leukemia (AML), accounting for one-third of diagnosed leukemias cases, represents a malignancy affecting the stem cell precursors of the myeloid lineage, including red blood cells, platelets, and white blood cells [Citation1]. Pediatric AML is the fifth most common malignancy in children, with treatment options encompassing conventional myelosuppressive chemotherapy with cytarabine and anthracyclines, molecularly targeted therapies, and hematopoietic stem cell transplant (HSCT) [Citation2,Citation3]. The high intense therapy, long duration of treatment, and the unsatisfactory clinical outcomes not only affect pediatric AML patients themselves, but also bring a burden to their caregivers, especially parents [Citation3–5]. Furthermore, several literatures have reported that parents of pediatric AML patients suffer from comparatively risks of psychological disorders, such as anxiety, depression, and post-traumatic stress disorder (PTSD), which may be induced by the physical pain of their children, the economic strain of treatments, the challenge of social isolation, concerns about their own health, responsibilities of providing supportive care, and etc. [Citation6–11]. Thus, it is necessary to address these psychological disorders in parents of pediatric AML patients.
Nowadays, many psychological interventions are utilized for addressing mental disorders of parents, such as narrative writing, emotion-elicited conversations, and cognitive-behavioral therapy (CBT) [Citation12–14]. Narrative writing of emotional and distressing experiences promotes self-reflection and emotional regulation, and reduces emotional sensitivity and inhibition, ameliorating mental problems in parents of children undergoing stem cell transplantation [Citation14]. Conversations with parents of leukemia children, aiming to elicit their adaptive emotions, will alleviate their stress [Citation13]. Additionally, CBT, focusing on cognitive restructuring through cognitive and behavioral interventions, and some interventions modified from CBT also show distress alleviation in parents of pediatric patients [Citation12,Citation15–17]. For instance, one study indicates that CBT improves psychosocial outcomes in parents of pediatric leukemia patients [Citation15]. It is shown that an intervention based on CBT (namely, psycho-education, paced respiration, and relaxation) mitigates distress in family caregivers of allogeneic HSCT patients [Citation16]. Another intervention based on CBT (namely, promoting resilience in stress management for parents) improves resilience and relieves psychological distress in parents of leukemia children [Citation17].
Cognitive-behavioral stress management (CBSM) is also a psychological approach based on CBT to reduce stress by directly enhancing individuals’ psychological coping abilities [Citation18,Citation19]. In addition to regular CBT interventions, CBSM adds other interventions focusing on stress management skills, such as stressors and stress awareness, anger management, relaxation training, and coping skills training [Citation19,Citation20]. One study indicates that CBSM reduces anxiety, depression, and stress in parents of children with chronic diseases [Citation21]. However, the influence of CBSM in parents of pediatric AML patients, who suffer from mental health challenges [Citation22], has not been explored.
Hence, this randomized, controlled study aimed to investigate the effect of CBSM on anxiety, depression, and PTSD in parents of pediatric AML patients.
Materials and methods
Participants
A total of 56 pediatric AML patients who were treated at our hospital from April 2018 to March 2022 and their 100 parents (12 single-parent families) were enrolled in this randomized controlled study. The inclusion criteria for pediatric AML patients were: (a) were diagnosed as AML; (b) were aged <16 years; (c) expected survival ≥6 months; and (d) parents with no documented mental illness and could complete the evaluation scales normally. The exclusion criteria were: (a) parents did not want to participate in this study or complete the evaluation scales; (b) French-American-British (FAB) classification of M3; (c) had other malignant diseases; and (d) concurrent participation in other clinical studies. This study was approved by the Ethics Committee of Affiliated Hospital of Hebei Engineering University (No. 2023[K]027). All families signed an informed consent form.
Random groupings
Each patient and his/her corresponding parents were randomized in a 1:1 ratio. The block randomization method was used and the block size was 4. Each patient and his/her corresponding parents received a serial number together. Their random message was placed in an opaque sealed envelope by two nurses who were completely unaware of it. At discharge, patients and their parents got their grouping information (the patients and their parents were included in the same group). The normal care (NC) group consisted of 28 patients and 51 parents, and the CBSM group also consisted of 28 patients and 49 parents.
Intervention
Parents who were assigned to the NC group received a one-hour education session at the time of discharge. The main contents involved two parts: (1) distribution and explanation of the professional education booklets were conducted, which included disease-related education, healthy diet, home exercise, and psychological health. It took about half an hour. (2) The nurse gave parents basic instructions on how to manage their emotions, for example, exercise regularly, listen to music, increase social activities, etc. It took approximately half an hour or so. Besides, at the time of discharge, the parents left their contact information. The nurse gave the necessary support by telephone for 10 weeks.
Parents who were assigned to the CBSM group were given the same one-hour education at discharge as the NC group and left their contact information for the nurses to communicate with them regularly after discharge. In addition, parents were divided into teams for the CBSM course based on the discharge time, with approximately 10 families in each team, and assigned 2–3 nurses. Parents came to the hospital once a week for about two hours per class. The CBSM intervention was conducted for a total of 10 weeks. The learning content of each class was: (1) psycho-educational learning. Parents learned different dimensions of stress management, such as emotional, behavioral, cognitive, physical, and social stress responses. (2) Correction of faulty cognitive and emotional regulation methods. The nurse taught them how to engage in cognitive reframing, anger management, stress release, etc. (3) Anxiety and stress release training. The nurse showed the parents how to do breathing exercises, meditation, massage, etc. (4) Emotional confessions. Parents could have one-on-one communication with the nurse about their anxiety and depression, and the nurse would help parents to manage their emotions according to their situation. (5) Post-class communication and sharing. Parents could share their own learning experiences, express difficulties to ask for help from other parents, and share their daily life, which enhanced parents’ social connection and helped them relieve their anxiety and depression.
Evaluation of anxiety and depression
Self-rating anxiety scale (SAS score), anxiety, self-rating depression scale (SDS score), and depression were evaluated at the time of discharge (M0), the first month (M1), the third month (M3), and the sixth month (M6) after discharge. The SAS and SDS scores were used to evaluate parents’ anxiety and depression levels. In comparison with the commonly used clinical scales (such as HADS-A and HADS-D scores), the SAS and SDS scores had a more comprehensive evaluation system, which reflected more comprehensive issues and provided more accurate and objective results. SAS and SDS scores covered 20 subjective feeling items related to anxiety and depression, with four grades for each item, from 1 (none or a little time) to 4 (most or all of the time). The total score was 100, with higher scores indicating higher levels of parental anxiety or depression [Citation23]. SAS scores ≥50 were regarded as anxiety, and SDS scores ≥50 were regarded as depression. The SAS score at M6 was considered the primary outcome.
Evaluation of symptom checklist-90 (SCL-90) score
The SCL-90 score was evaluated at M0, M1, M3, and M6, which was used to evaluate parents for psychotic status. The SCL-90 score included 90 items, each of which was divided into 5 grades ranging from 0 (never) to 4 (severe). The total score was 360, with higher scores indicating a more severe psychotic status [Citation24].
Evaluation of the impact of the events scale-revised (IES-R) score
The IES-R score was evaluated at M0, M1, M3, and M6. The IES-R score was used to evaluate parents for PTSD. The scale had 22 items, each of which was divided into 5 grades ranging from 0 (not at all) to 4 (very severe). The total score was 88, with higher scores indicating more severe parental PTSD [Citation25].
Statistics
The minimum sample size for this study was calculated according to clinical experience. The mean SAS score at M6 was presumed to be 50 for the NC group and 40 for the CBSM group. The standard deviation (SD) was presumed to be 15. The significance (α) level was 0.05, and the power was 85%. The minimum sample size was 42. The study accounted for the possibility that 15% of participants would be unwilling to participate or would be lost in the follow-up, which resulted in 49 participants in each group. The software used for data analysis was SPSS 22.0 (IBM Corp., USA). For data presentation, continuous variables with normal distribution were presented with mean ± SD, continuous variables with skewed distribution were presented with median and inter-quartile range (IQR), and categorical variables were presented with numbers (percentages). Comparative analyses were conducted using a t-test, Mann–Whitney U-test, Kruskal Wallis H-test, chi-square test, and Fisher exact test. p-values less than 0.050 were considered significant differences.
Results
Study flow
This study screened 71 pediatric AML patients and 125 of their parents, of which 15 pediatric AML patients and 25 parents were excluded due to unwillingness to participate, not meeting the inclusion criteria, or meeting the exclusion criteria. Finally, 56 pediatric AML patients and 100 parents were enrolled. Each patient and his/her corresponding parents were randomized into two groups at a 1:1 ratio. There were 28 patients and 49 parents in the CBSM group, and parents in this group received CBSM intervention for 10 weeks. There were 28 patients and 51 parents in the NC group, and parents in this group received NC intervention for 10 weeks. SAS score and anxiety, SDS score and depression, SCL-90 score, and IES-R score at M0, M1, M3, and M6 were evaluated and the date analyses followed the intention-to-treat principle ().
Figure 1. Chart illustrating the study flow. A total of 56 pediatric AML patients and 100 parents were enrolled and randomized into the CBSM group and the NC group to receive 10-week CBSM and NC, respectively. The questionnaire scores were evaluated at M0, M1, M3, and M6.
Clinical information of pediatric AML patients and their parents
The mean age of pediatric AML patients was 7.1 ± 3.0 years in the CBSM group and 6.9 ± 2.6 years in the NC group. There were 19 (67.9%) and 16 (57.1%) male patients in the CBSM group and the NC group, respectively. No difference was found in demographics or clinical characteristics in pediatric AML patients between the two groups (all p > 0.050, ).
Table 1. Clinical characteristics of pediatric AML patients.
There were 27 (55.1%) mothers and 22 (44.9%) fathers in the CBSM group, as well as 26 (51.0%) mothers and 25 (49.0%) fathers in the NC group. The mean age of parents was 35.2 ± 3.8 years in the CBSM group and 35.6 ± 4.1 years in the NC group. The demographics and clinical characteristics of parents were of no difference between the two groups (all p > 0.050, ).
Table 2. Clinical characteristics of parents.
Comparison of SAS score and anxiety in parents between the CBSM group and the NC group
SAS score at M1 (p = 0.034), M3 (p = 0.010), and M6 (p = 0.003) were decreased in parents of the CBSM group compared to those of the NC group, while SAS score at M0 (p = 0.739) was not varied. Anxiety at M3 (p = 0.036) and M6 (p = 0.012), but not at M0 (p = 0.848) or M1 (p = 0.142), were decreased in parents of the CBSM group compared to those of the NC group ().
Table 3. Comparison of SAS score and anxiety in parents.
Comparison of SDS score and depression in parents between the CBSM group and the NC group
SDS score at M3 (p = 0.022) and M6 (p = 0.002), but not at M0 (p = 0.602) or M1 (p = 0.115), were declined in parents of the CBSM group compared to those of the NC group. Depression at M6 (p = 0.019) was also decreased in parents of the CBSM group compared to those of the NC group, while depression at M0 (p = 0.562), M1 (p = 0.280), and M3 (p = 0.060) were of no difference in parents between the two groups ().
Table 4. Comparison of SDS score and depression in parents.
Comparison of SCL-90 score in parents between the CBSM group and the NC group
SCL-90 score at M3 (p = 0.031) and M6 (p = 0.019) were declined in parents of the CBSM group compared to those of the NC group. There was of no difference in SCL-90 score at M0 (p = 0.766) or M1 (p = 0.150) in parents between the CBSM group and the NC group ().
Table 5. Comparison of SCL-90 score in parents.
Comparison of IES-R score in parents between the CBSM group and the NC group
IES-R score at M3 (p = 0.044) and M6 (p = 0.010) were decreased in parents of the CBSM group compared to those of the NC group. No difference was found in IES-R score at M0 (p = 0.815) or M1 (p = 0.178) in parents between the CBSM group and the NC group ().
Table 6. Comparison of IES-R score in parents.
Subgroup analyses
In parents of pediatric AML patients without anxiety at M0, none of the outcomes at M6 was different between the CBSM group and the NC group (all p > 0.050). While in parents with anxiety at M0, SAS score (p = 0.011), anxiety (p = 0.009), SDS score (p = 0.007), depression (p = 0.020), SCL-90 score (p = 0.003), and IES-R score (p = 0.034) at M6 were decreased in the CBSM group compared to the NC group. In parents without depression at M0, all outcomes at M6 were not different between the CBSM group and the NC group (all p > 0.050). Differently, in parents with depression at M0, SAS score (p = 0.018), anxiety (p = 0.036), SDS score (p = 0.014), depression (p = 0.016), SCL-90 score (p = 0.013), and IES-R score (p = 0.032) at M6 were reduced in the CBSM group compared to the NC group ().
Table 7. Subgroup analysis of outcomes at M6 in parents.
In parents aged ≤35 years, SAS score at M1 (p = 0.001) and M6 (p = 0.016), anxiety at M1 (p = 0.009) and M6 (p = 0.026) were declined in the CBSM group compared to the NC group. While in parent aged >35 years, SDS score at M6 (p = 0.011) and IES-R score at M3 (p = 0.021) and M6 (p = 0.030) were reduced in the CBSM group than the NC group (Supplementary Table 1).
In fathers of pediatric AML patients, SDS score at M3 (p = 0.033) and M6 (p = 0.037), IES-R score at M3 (p = 0.033) and M6 (p = 0.005) were reduced, but SCL-90 score at M0 (p = 0.047) was increased in the CBSM group compared to the NC group. Regarding mothers of these patients, SAS score at M1 (p = 0.014), M3 (p = 0.029), and M6 (p = 0.003), anxiety at M6 (p = 0.019), SDS score at M6 (p = 0.023), depression at M6 (p = 0.019), and SCL-90 score at M1 (p = 0.003), M3 (p = 0.001), and M6 (p < 0.001) were decreased in the CBSM group than the NC group (Supplementary Table 2).
Discussion
CBSM is applicated for cancer patients and is proved to reduce their anxiety and depression in several studies [Citation19,Citation26]. As a core in family cohesion and spiritual connections, parents would encounter anxiety and depression when their children have health concerns, but this issue is overlooked [Citation27,Citation28]. This study enrolled parents (including single parents) of pediatric AML patients and found that CBSM realized decreased anxiety compared to NC in them. The possible explanation could be: (1) CBSM alleviated mental tension through relaxation training [Citation29]. (2) CBSM provided one-on-one communication with professional support to reduce parents’ fear of disease conditions, treatment side effects, and potential complications, and to instill their confidence [Citation30]. (3) CBSM encouraged parents to ask for help from others, which enhanced parents’ social connection [Citation31]. Thereby, CBSM reduced anxiety in parents of pediatric AML patients.
Besides, this study found that CBSM reduced depression in parents of pediatric AML patients compared to NC. The possible explanations could be: (1) CBSM provided parents multiple methods, such as psycho-education and relaxation, to break repetitive negative thoughts [Citation32]. (2) CBSM could reduce parents’ neuroendocrine stress response to an acute stressor, consequently helping them avoid engaging in negative actions [Citation33]. (3) CBSM helped parents strengthen their beliefs through pouring out the negative emotions and learning experiences from others [Citation34]. Consequently, CBSM ameliorated depression in parents of pediatric AML patients.
Additionally, this study adopted the SCL-90 score, which contained more comprehensive aspects of psychological and symptomatic distress [Citation24]. In this study, the SCL-90 score at M0 was 138.8 ± 24.7 and 140.3 ± 26.2 in the two groups, which was higher than the average data in parents of healthy children (117.2 ± 27.3, 128.9 ± 36.4, or 131.05 ± 39.75) [Citation35,Citation36], reflecting severe psychosomatic symptomatology in parents of pediatric AML patients. Moreover, the SCL-90 score at M6 was 119.6 ± 26.5 in parents of pediatric AML patients treated by CBSM, which was similar to the average data in parents of healthy children [Citation35,Citation36], suggesting the amelioration of CBSM for psychotic status. The possible explanation could be CBSM reduced anxiety, depression, and psychological stress in parents of pediatric AML patients, alleviating their psychotic status [Citation21]. Importantly, CBSM realized a decreased SCL-90 score at M3 and M6 compared to NC in parents of pediatric AML patients. The possible reason could be CBSM provided multiple interventions and social support for parents to alleviate their psycho-psychiatric problems, while interventions of NC were simpler and more limited, consisting mainly of educational sessions at discharge and telephone support [Citation20]. As a result, CBSM shown better effect for alleviating psychotic status compared to NC in parents of pediatric AML patients.
Due to the concerns of disease progression and poor survival of pediatric AML patients, their parents tend to have PTSD [Citation37–39]. Meanwhile, this study found that IES-R scores at M3 and M6 were declined in parents receiving CBSM compared to those receiving NC, reflecting the better effect of CBSM to reduce PTSD in parents. The possible explanation could be CBSM not only offered comprehensive and various interventions in alleviating PTSD, but also provided parents opportunities to train and develop the skill for dealing with PTSD over time [Citation19]. Accordingly, CBSM was more effective for PTSD relief compared to NC in parents of pediatric AML patients.
Subgroup analyses were performed and indicated that parents of pediatric AML patients with anxiety at M0 or depression at M0 benefited more from CBSM. The possible explanation could be: (1) the psychological status of parents with depression or anxiety at M0 was worse than those without anxiety or depression at M0; thus, CBSM helped these patients release more stress and negative emotions and achieve a better treatment efficacy [Citation40]. (2) CBSM facilitated the awareness of their mental status in parents with anxiety or depression at M0; thereby, these parents might have a higher willingness to engage in the intervention [Citation41]. In conclusion, the effect of CBSM was more obvious in parents with anxiety or depression at baseline.
Some limitations still existed in this study. To begin with, the follow-up duration in this study was relatively short, therefore, the effect of CBSM in a long run needed further investigation. Besides, although a minimum sample calculation was performed in this study, the statistical power of subgroup analyses was weakened under the relatively small sample size. Moreover, as the SAS/SDS/SCL-90/IES-R scores were all completed by parents of pediatric AML patients themselves, these scale scores potentially existed for self-assessment bias. Thus, other psychological scales completed by professional doctors (such as Hamilton Anxiety/Depression Scale) could be added to enhance credibility. Finally, according to previous studies [Citation42–45], psychological improvement of parents is associated with reduced child internalizing and externalizing symptoms, elevated child medication adherence, alleviated children’s disease symptoms, and promoted the quality of life in pediatric patients. Thereby, the specific influence of CBSM-induced improvements in parents’ well-being on their children required further exploration.
In summary, CBSM alleviates anxiety, depression, and PTSD in parents of pediatric AML patients, empowering these parents to achieve a healthy psychological status and offer care for their children with a positive mindset. This implies the importance for clinical physicians to pay attention to the mental health of parents of pediatric AML patients. Meanwhile, the findings suggest the potential utility of CBSM as a beneficial psychological intervention for AML caregivers.
Compliance with ethical standards
This study was approved by the Ethics Committee. All families signed an informed consent form.
Supplemental Material
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Download MS Word (43.9 KB)Acknowledgements
Authors’ contributions: LW and HD contributed to the study conception and design. Material preparation and data collection were performed by LW, HD and HZ. ZW, SJ, YL, HL, JC contributed to the data analysis. The first draft of the manuscript was written by LW and HD. All authors revised the manuscript. All authors read and approved the final manuscript.
Disclosure statement
No potential conflict of interest was reported by the author(s).
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