Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT)

Figures & data

Table 1. Cognitive Behavioral Therapy (CBT) session content and between-session homework.

Session	CBT Session Content	Between-Session Homework
1	Assess participant’s concerns Create problem list Discuss treatment plan Collaboratively set treatment goals Identify potential barriers	Reflect on the session and consider feedback for the therapist Consider revisions to the problem list and treatment plan created during session
2	Orient participant to CBT, principles of treatment, and the CBT model Introduce behavioral activation (BA)	Complete activity planning and mood monitoring worksheet
3	Discuss challenges, barriers, and successes to engaging in BA Increase activity scheduling	Complete activity planning and mood monitoring worksheet
4	Introduce cognitive side of triangle Explain difference between thoughts and feelings Discuss becoming more aware of automatic thoughts and feelings Begin tracking degree of belief in a thought and intensity of emotion	Complete a total of seven 3-column thought records (one per day) prior to the next session Continue engaging in activity planning and mood monitoring
5	Cognitive distortions Challenge maladaptive thoughts and beliefs	Complete a total of seven 7-column thought records (one per day) prior to next session Continue engaging in activity planning and mood monitoring
6	Complete a 7-column thought record Check-in on goals and treatment Plan Discuss maintenance of BA. Address stuck points and integrate problem-solving techniques as needed	Complete a total of seven 7-column thought record worksheets (one per day) prior to next session Continue engaging in activity planning and mood monitoring
7	Continue to work through 7-column thought records Revisit maintenance of BA Discuss any concerns with participant regarding treatment termination next session	Complete a total of seven 7-column thought record worksheets (one per day) prior to next session Continue engaging in activity planning and mood monitoring Prepare any questions, concerns, or reflections for next (termination) session
8	Review participant’s progress Discuss strategies to maintain improvements Create a relapse prevention plan	None

Figure 1. Participant flow through study.

Table 2. Participant characteristics.

Characteristic	N = 16
Age, years, M (SD)	41.9 (12.6)
Sex assigned at birth, N (%)
Male	7 (43.8%)
Female	9 (56.3%)
Gender N (%)
Man	3 (18.8%)
Woman	4 (25.0%)
Genderqueer	5 (31.3%)
Agender	4 (25.0%)
Race and Ethnicity N (%)
African American/Black	0 (0.0%)
Asian	3 (18.8%)
Latino/Hispanic	1 (6.3%)
Native American	0 (0.0%)
Pacific Islander	0 (0.0%)
White/Caucasian	9 (56.3%)
More Than One Race [1]	3 (18.8%)
Education N (%)
High School Diploma or GED	0 (0.0%)
Some college	0 (0.0%)
Bachelor’s Degree (e.g. BA, BBA, BS)	7 (43.8%)
Master’s Degree (e.g. MA, MS, Meng)	4 (25.0%)
Doctoral Degree (e.g. PhD, EdD)	5 (31.3%)
BMI, kg/m2, M (SD)	24.7 (4.1)
Blood pressure, mm Hg, M (SD)	123.1/82.9 (18.4/12.6)
Beck Depression Inventory II (BDI-II), M (SD)	29.44 (5.56)

¹Among 3 participants who reported more than one race or ethnicity, n = 2 participants reported both Asian and White or Caucasian race, and n = 1 participant reported both African American or Black, and White or Caucasian race.

Table 3. Adverse events (AEs).

AE	# AEs	# of participants reporting AE	Related to Study Intervention / Expected? / # AEs	N (%) AEs resolved by end of WBH visit	N (%) AEs resolved by end of WBH day
Lightheadedness	19	8	Definitely / Yes	13 (68.4%)	6 (31.6%)
Headache	8	4	Definitely / Yes	3 (37.5%)	5 (62.5%)*
Nausea	8	4	Definitely / Yes	8 (100%)	0 (0%)
Jitteriness	4	1	Definitely / Yes	3 (75%)	1 (25%)
Migraine	3	2	Definitely / Yes / 2 Possibly / Yes / 1	0 (0%)	3 (100%)
Heat Rash	2	1	Definitely / Yes	0 (0%)	2 (100%)
Heart Palpitations	2	2	Definitely / Yes	2 (100%)	0 (0%)
Shin pain	1	1	Definitely / Yes	1 (100%)	0 (0%)
Tingling in arms and legs	1	1	Definitely / Yes	1 (100%)	0 (0%)
Nighttime overheating and body pain	1	1	Definitely / Yes	0 (0%)	0 (0%)**
Tinnitus	1	1	Possibly / No	0 (0%)	1 (100%)
Vomiting****	1	1	Definitely / Yes	1 (100%)	0 (0%)
Loose bowels****	1	1	Possibly / No	0 (0%)	0 (0%)***

*1 case of this symptom resolved by the end of the day after the WBH session.

** This symptom resolved by the end of the day after the WBH session.

*** This symptom resolved 3 days after the WBH session.

**** All AEs were coded as mild, except for vomiting and loose bowels.

Table 4. Changes in self-report measures of mood and affect.

N = 12 Measure	M (SE) Baseline Visit	M (SE) Final Visit	M Diff (Final – Baseline)	95% CI (LB, UB)	P
BDI-II	28.75 (1.01)	12.92 (2.88)	–15.83	(–21.97, −9.70)	0.0001
PROMIS-29
Depression 4 A	64.15 (1.18)	57.92 (2.26)	–6.23	(–11.49, −0.98)	0.024
Anxiety 4 A	65.01 (1.76)	55.54 (2.87)	–9.47	(–15.81, −3.12)	0.0073
Fatigue 4 A	61.71 (1.70)	49.92 (2.87)	–11.79	(–18.95, −4.63)	0.0040
Sleep Disturbance 4 A	59.37 (1.68)	53.26 (1.83)	–6.11	(–9.33, −2.89)	0.0015
Social Role Abilities 4 A	40.67 (0.99)	50.99 (2.62)	10.32	(4.52, 16.12)	0.0024
Pain Interference 4 A	51.43 (2.64)	46.29 (2.09)	–5.14	(–10.29, 0.00)	0.050
Pain Intensity 1 A	2.33 (0.56)	1.00 (0.35)	–1.33	(–2.46, −0.21)	0.025
PROMIS-8a Depression*	62.42 (2.06)	54.33 (2.26)	–8.08	(–12.19, −3.98)	0.0012
ATQ-R	87.17 (4.39)	66.58 (7.99)	–20.58	(–32.68, −8.48)	0.0032
CFI	89.33 (5.69)	96.92 (4.72)	7.58	(–2.60, 17.76)	0.13
N = 12 Measure	M (SE) Pre-Session	M (SE) Post-Session	M Diff (Post – Pre Session)	95% CI (LB, UB)	P
BMIS: Score: Single Mood Item
First WBH Session	0.50 (1.36)	3.42 (1.35)	2.92	(2.08, 3.75)	<0.0001
First CBT Session	0.50 (1.35)	1.83 (1.25)	1.33	(0.14, 2.52)	0.031
All WBH Sessions	2.57 (1.08)	4.39 (1.08)	1.82	(1.18, 2.46)	<0.0001
All CBT Sessions	2.56 (1.04)	3.54 (1.04)	0.98	(0.38, 1.58)	0.0014
BMIS Score: Total Score (16 Items)
First WBH Session	38.50 (1.96)	47.00 (2.19)	8.50	(4.79,12.21)	0.0004
First CBT Session	37.67 (1.90)	42.58 (2.07)	4.92	(2.10, 7.74)	0.0028
All WBH Sessions	41.37 (1.83)	47.43 (1.83)	6.06	(4.81,7.30)	<0.0001
All CBT Sessions	41.72 (1.48)	44.26 (1.48)	2.54	(1.28,3.80)	0.0001

Note. BDI-II = Beck Depression Inventory II; PROMIS = Patient-Reported Outcomes Measures; ATQ-R = Automatic Thoughts Questionnaire-Revised; CFI = Cognitive Flexibility Inventory. *PROMIS-8a Depression scores computed as the averages between (1) up to 7 days between the baseline visit and the first intervention visit (CBT or WBH), and (2) up to 7 days between the last intervention visit (CBT or WBH) and the final assessment visit. BMIS = Brief Mood Introspection Scale, see Methods for BMIS variable descriptions.

Table

	Measure	M (SE) Baseline Visit	M (SE) Final Visit	M Diff (SE) (Final – Baseline)	95% CI (LB, UB)	P
Offered 8 WBH sessions (n = 5)	BDI-II	28.8 (0.86)	12.00 (3.41)	–16.80	(–27.20, −6.40)	0.011
	PROMIS-29
	Depression 4 A	64.66 (1.19)	58.58 (1.68)	–6.08	(–12.63, 0.47)	0.062
	Anxiety 4 A	65.80 (2.91)	54.82 (5.01)	–10.98	(–23.65, 1.69)	0.074
	Fatigue 4 A	62.26 (3.84)	53.66 (3.52)	–8.60	(–18.75, 1.55)	0.078
	Sleep Disturbance 4 A	60.22 (3.99)	55.64 (3.20)	–4.58	(–9.37, 0.21)	0.057
	Social Role Abilities 4 A	40.96 (1.14)	47.26 (2.31)	6.30	(0.43, 12.17)	0.041
	Pain Interference 4 A	55.82 (3.83)	47.60 (3.95)	–8.22	(–18.65, 2.21)	0.094
	Pain Intensity 1 A	2.80 (1.20)	1.20 (0.58)	–1.60	(–4.72, 1.52)	0.23
	PROMIS Depression 8 A*	63.98 (2.40)	57.07 (2.30)	–6.91	(–12.84, −0.98)	0.032
	ATQ–R	89.20 (4.58)	62.60 (8.36)	–26.60	(–44.46, −8.74)	0.014
	CFI	86.40 (10.25)	90.80 (7.03)	4.40	(–15.54, 24.34)	0.57
Offered 4 WBH sessions (n = 7)	BDI-II	28.71 (1.69)	13.57 (4.52)	–15.14	(–25.39, −4.89)	0.011
	PROMIS-29
	Depression 4 A	63.79 (1.91)	57.44 (3.82)	–6.34	(–15.91, 3.22)	0.16
	Anxiety 4 A	64.44 (2.36)	56.06 (3.72)	–8.39	(–18.09, 1.32)	0.079
	Fatigue 4 A	61.31 (1.43)	47.24 (4.14)	–14.07	(–26.26, −1.88)	0.030
	Sleep Disturbance 4 A	58.76 (1.06)	51.56 (2.11)	–7.20	(–12.58, −1.82)	0.017
	Social Role Abilities 4 A	40.47 (1.57)	53.66 (4.02)	13.19	(3.28, 23.09)	0.017
	Pain Interference 4 A	48.30 (3.32)	45.36 (2.43)	–2.94	(–10.08, 4.20)	0.35
	Pain Intensity 1 A	2.00 (0.49)	0.86 (0.46)	–1.14	(–2.27, −0.02)	0.047
	PROMIS Depression 8 A*	61.30 (3.17)	52.38 (3.47)	–8.92	(–16.05, −1.80)	0.022
	ATQ-R	85.71 (7.06)	69.43 (12.82)	–16.29	(–36.45, 3.88)	0.095
	CFI	91.43 (7.06)	101.29 (6.23)	9.86	(–5.73, 25.45)	0.17

Note. See Table 4 note.

Data availability statement

The data that support the findings will be available at OSF (https://osf.io/), together with a data dictionary, upon publication.