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ACTIVE: Activity Therapy to Increase Veteran Engagement

A Feasibility Study of Behavioral Activation in the Rehabilitation of Veterans With Post-TBI Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04976621
Acronym
ACTIVE
Enrollment
46
Registered
2021-07-26
Start date
2022-02-15
Completion date
2024-06-03
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

rehabilitation, depression, veterans

Brief summary

Depression is common after traumatic brain injury (TBI) and may have wide-ranging consequences. Post-TBI depression may impede reintegration into the family and community and lead to lower quality of life and heightened suicide risk. It may also interfere with rehabilitation. Yet, current treatments for post-TBI depression are based largely on expert opinion rather than evidence from rigorous studies. Behavioral activation (BA) is a promising intervention for post-TBI depression. It is a brief behavioral treatment that helps people define goals, create and execute plans to reach them, and engage in meaningful activities. BA has been tested in clinical trials since the 1970s and has been shown to reduce or prevent depression in populations with diverse medical conditions. However, BA has rarely been used or studied for treatment of depression in a TBI population. The investigators will conduct a study of BA with at least 40 Veterans with TBI and depressive symptoms in VA outpatient rehabilitation care. One group of Veterans will be randomly assigned to receive BA plus usual care. The BA program consists of six sessions delivered over three months at the VA (or Veterans' homes, if preferred) by an occupational therapist (OT). A second group of Veterans will be randomly assigned to receive usual care. The investigators will assess the feasibility of delivering the BA intervention in the rehabilitation setting and its acceptability to Veterans and staff. The research team will also assess participant responses to BA in the outcomes of depressive symptoms, community reintegration, and quality of life. Study findings will be used to guide the development of a future study of BA in a larger sample of Veterans with post-TBI depression. This study and future research may add a powerful clinical tool to rehabilitation services to lessen or prevent depression in Veterans with TBI. Reducing depression may in turn facilitate rehabilitation and enhance community reintegration, allowing Veterans to engage more fully in their families and communities.

Detailed description

Objectives: Nearly 400,000 Veterans have been diagnosed with traumatic brain injury (TBI) since 2000, representing up to 22% of combat casualties. Depression is one of the most prevalent and serious of TBI sequelae. Post-TBI depression adversely affects rehabilitation, treatment adherence, community reintegration (CR), quality of life (QOL), social relationships, and caregiver burden. Yet, post-TBI depression remains under-assessed, undertreated, and under-studied. No clinical guidelines for post-TBI depression treatment exist, and current treatment is largely based on expert opinion rather than evidence from controlled clinical trials. A promising therapeutic approach to post-TBI depression is Behavioral Activation (BA), a brief and pragmatic treatment rigorously tested since the 1970s in clinical trials for depression in diverse clinical populations. BA helps individuals set goals, create plans, and engage in activities that improve mood and maintain social connectedness - making it well-suited to treating depression in a TBI population that struggles to set goals and is prone to social isolation. BA can accommodate hallmark deficits of TBI such as deficits in memory, organization, planning, initiation, emotion regulation, and interpersonal functioning. It can be delivered by professionals routinely available in VA outpatient rehabilitation services (e.g., occupational therapists, nurses, psychologists, social workers) and, therefore, can be deployed in rehabilitation settings. The proposed research will assess the feasibility of a BA protocol adapted for post-TBI depression in an outpatient VA rehabilitation setting. Specific study objectives are to: (1) assess BA's acceptability to Veterans and staff and other feasibility indices, (2) provide preliminary evidence of participant response in the outcomes of depressive symptoms, CR, and QOL at the 3-month follow-up interview, (3) develop the BA protocol and manual to be tested in a larger randomized controlled trial (RCT) in the future, and (4) explore engagement in activity as the mechanism that underlies BA intervention effects on outcomes. Research Design: This feasibility study includes a pilot randomized controlled trail to examine participant response. Methodology: This feasibility study will enroll at least 40 male and female Veterans receiving care at a VAMC Rehabilitation Medicine Service and meeting study criteria for TBI and depression. Veterans will be randomly assigned to BA plus treatment as usual (TAU) or control (TAU). The BA program consists of six sessions delivered over 3 months at the VA (or the Veteran's home, as preferred by Veteran) by an occupational therapist (OT). All Veterans are interviewed at baseline before randomization and 3 months later by a blinded interviewer. Both interviews assess Veterans' depressive symptoms, CR, and QOL, using standardized instruments. Feasibility will be assessed in six domains: acceptability to Veterans and clinic staff; process (recruitment, refusal, and retention rates; study completion; eligibility criteria; and number of sessions attended); practicality (resources and constraints imposed by the setting); safety; participant comprehension of interviews and the intervention; and research burden (length of interviews, participant fatigue, and emotional distress). After the follow-up interview, phone interviews with BA participants and with clinic staff will be conducted to capture acceptability and their experience with BA. These qualitative and quantitative methods are designed to test the feasibility of a future RCT, identify the barriers and facilitators to implementation of BA in the rehabilitation setting, and describe Veterans' experiences with BA. Impact/Significance: This study and line of research has the potential to advance knowledge by identifying a feasible and efficacious approach to preventing and/or mitigating depression among Veterans with TBI, a clinical population at high risk for depression and its sequelae. Findings will be used to inform the development of a future RCT powered to test BA's efficacy in a larger sample of Veterans with post-TBI depression.

Interventions

BEHAVIORALBehavioral Activation

BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. BA protocol components include: goal setting (especially for activities that promote social connectedness), creation of a plan (broken down into steps), strategies for implementation of steps, identification of potential barriers, tactics to overcome them, activity monitoring and scheduling, and emotion regulation strategies. The BA intervention will be delivered in 6 sessions over 3 months by Occupational Therapists trained in BA for post-TBI depression. BA sessions will be conducted in person in an office at the VA rehabilitation clinic, virtually by VA Video Connect, or in person in the home, depending on the veteran's preference.

OTHERTreatment as Usual

Treatment as Usual refers to usual care provided by the VA medical center.

Sponsors

Thomas Jefferson University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Care providers at the medical center will not have knowledge of the intervention or control condition assigned to individual participants. The research interviewer at the follow-up interview (the outcome assessor) also has no knowledge of the intervention or control condition assigned to individual participants.

Intervention model description

At the baseline interview, the interviewer will review the study, answer questions, obtain Informed Consent, conduct screening for eligibility, and conduct the baseline interview. The interview will be conducted in the rehabilitation clinic office, by VA Video Connect, or in the home. Veterans who do not wish to continue with the study after the baseline interview will not be randomized. Within 48 hours of the baseline interview, eligible veterans will be randomized using the method of random permuted blocks and concealed allocation. Those randomized to BA will be contacted within 5 days by the interventionist and scheduled for the first session. They will receive the 6-session BA intervention (as well as treatment as usual \[TAU\]). Control participants will receive TAU only (which may include current medical and mental health treatments.) Three months after Baseline, a blinded interviewer will conduct the follow-up interview in person or on the phone with all veterans.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veteran enrolled in the outpatient Rehabilitation Medicine Service at the Corporal Michael J. Crescenz VA Medical Center * Age of 21 years or older * Meet professional criteria for mild or moderate TBI * Confirmation of TBI diagnosis * Have a CES-D score at or above 16 at both the Telephone Screen and Baseline * Those taking antidepressants or other medications affecting mood or behavior must have been using these for at least three months, to allow for stabilization. * Those in psychotherapy can participate if therapy has been ongoing for three months or longer. * Veterans report current TBI-related symptoms on the Telephone Screen. * Speak English

Exclusion criteria

* A diagnosis of severe TBI * Psychosis * Aphasia * History of bipolar disorder * Presence of suicidal ideation with affirmative response on item 9 of the PHQ-9 * History of severe physical aggressiveness, judged by the clinical team * Currently receiving Cognitive Behavioral Therapy for depression * Dementia (determined on case-by-case basis based on physician diagnosis and participant's difficulty understanding interview questions)

Design outcomes

Primary

MeasureTime frameDescription
Depressive Symptom Scores on CES-D3 - 4 monthsDepressive symptoms will be measured by The Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a well-established 20-item screening instrument that shows good psychometric properties in TBI populations. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a Likert-type scale from 0 to 3. The total score is the sum across all 20 items. Total scores may range from 0 to 60, with higher scores indicating greater depressive symptoms.

Secondary

MeasureTime frameDescription
Community Reintegration Scores on PART-O-173 - 4 monthsThe Participation Assessment with Recombined Tools-Objective scale (PART-O-17) measures participation in the community in three domains: Productivity, Out and About, and Social Relations. In our study, scores were converted to z scores because more than one response format was used across items. When data are converted to Z scores, the sample mean is always 0. Scores (i.e., Z scores, not standard deviations) above 0 indicate better than average community participation, those below 0 indicate worse participation. Thus, higher scores of this scale indicate better participation.
Quality of Life in TBI Scores on QoL-TBI Instrument3 - 4 monthsQuality of life in TBI will be measured by The QoL-TBI instrument. This is a 37-item patient-centered measure that captures the individual's perception of his/her health-related quality-of-life (HRQoL) in cognition, self-care, daily life and autonomy, social relationships, emotions, and physical problems. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a 5-point scale from 0 - Not at all to 4- Very. Although the published description of this tool designates sums across all items as a summary score, we computed the mean of all items. The reason is that the use of a sum poses a problem whenever there are missing data, which produces a spuriously lower score for individuals with some missing responses. Higher scores indicate better quality of life.

Other

MeasureTime frameDescription
Retention3 - 4 months for the number in each group that completed the Time 2 follow-up interview and up to 4 months for number in treatment group who completed at least four treatment sessions.Retention is considered part of the process domain of feasibility and will be measured in two ways. Retention will be measured by the number of treatment sessions completed over the total number of sessions (6) for only those in the treatment group. The percentage who completed at least four treatment sessions will be the criterion for this. Among those who are enrolled in both groups, retention is measured by the percentage in each group who completed the Time 2 follow-up interview (which occurred 3 - 4 months after the baseline interview).
Acceptability of the Intervention Rated by the Interventionist3 - 4 monthsAcceptability is measured by the Acceptance/Receipt Scale and is completed by the interventionist at the last intervention session. This is an 18-item tool with Likert scale response formats from 0 to 4. A mean score will be obtained and ranges from 0 to 4. Higher scores indicate increased acceptability.
Treatment Fidelity18 monthsTreatment fidelity is considered part of the process domain of feasibility. This will be measured by the Treatment Fidelity Checklist, a 15-item tool with a 3-point scale with responses from 1 (poor) to 3 (excellent). The mean will be computed for the 15 items for each recorded interview. The percentage of the interviews that had a mean less than 2.0 will be computed and will be the measure of treatment fidelity. Our criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.
Veteran Acceptability/Satisfaction With the Intervention3 - 4 monthsAcceptability/Satisfaction with the intervention will be measured with the Acceptability/Satisfaction Scale and is completed by the participants who received Behavioral Activation after the last intervention session when the qualitative interview is also conducted. This is a 12 item tool with a Likert scale response format from 0 to 4. A mean score will be obtained and ranges from 0 to 4. A higher score indicates increased acceptability/satisfaction.
Recruitment16 monthsRecruitment is considered part of the process domain of feasibility. Recruitment will be measured by the percentage of veterans eligible for the study among those screened and the percentage willing to participate among those screened. Among those screened, our criteria for recruitment is that 50% or more will be eligible for the study and that at least 30% will be willing to participate.

Countries

United States

Participant flow

Pre-assignment details

46 participants were consented and enrolled, but 5 were deemed ineligible after the baseline interview (1 with CES-D score \< 16; 3 with suicidal ideation on item 9 of the PHQ-9; and 1 with inability to take part in the interview).

Participants by arm

ArmCount
Behavioral Activation (BA) Intervention Group
Participants in the BA group will receive BA treatment and treatment as usual. BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. The BA intervention will be delivered in 6 sessions over 3 months by Occupational Therapists trained in BA for post-TBI depression. BA sessions will be conducted in person in an office at the VA rehabilitation clinic, virtually by VA Video Connect, or in person in the home, depending on the veteran's preference. Behavioral Activation: BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. BA protocol components include: goal setting (especially for activities that promote social connectedness), creation of a plan (broken down into steps), strategies for implementation of steps, identification of potential barriers, tactics to overcome them, activity monitoring and scheduling, and emotion regulation strategies. The BA intervention will be delivered in 6 sessions over 3 months by Occupational Therapists trained in BA for post-TBI depression. BA sessions will be conducted in person in an office at the VA rehabilitation clinic, virtually by VA Video Connect, or in person in the home, depending on the veteran's preference. Treatment as Usual: Treatment as Usual refers to usual care provided by the VA medical center.
19
Treatment as Usual Control Group
Participants in the Control group receive treatment as usual (TAU), which is usual care provided by the VA medical center. Treatment as Usual: Treatment as Usual refers to usual care provided by the VA medical center.
22
Total41

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicTreatment as Usual Control GroupTotalBehavioral Activation (BA) Intervention Group
Age, Continuous47.32 years
STANDARD_DEVIATION 11.11
47.24 years
STANDARD_DEVIATION 12.68
47.16 years
STANDARD_DEVIATION 14.61
Community Reintegration Scores on PART-O-17-.03 Z score
STANDARD_DEVIATION 0.3
-0.00 Z score
STANDARD_DEVIATION 0.33
.07 Z score
STANDARD_DEVIATION 0.34
Depressive Symptom Scores on CES-D31.58 units on a scale
STANDARD_DEVIATION 6.3
33.78 units on a scale
STANDARD_DEVIATION 6.6
35.56 units on a scale
STANDARD_DEVIATION 6.45
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants4 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants37 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Quality of Life in TBI Scores on QoL-TBI Instrument2.00 units on a scale
STANDARD_DEVIATION 0.4
1.94 units on a scale
STANDARD_DEVIATION 0.36
1.90 units on a scale
STANDARD_DEVIATION 0.31
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants15 Participants5 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants23 Participants13 Participants
Region of Enrollment
United States
22 Participants41 Participants19 Participants
Sex: Female, Male
Female
4 Participants6 Participants2 Participants
Sex: Female, Male
Male
18 Participants35 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 22
other
Total, other adverse events
7 / 195 / 22
serious
Total, serious adverse events
1 / 191 / 22

Outcome results

Primary

Depressive Symptom Scores on CES-D

Depressive symptoms will be measured by The Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a well-established 20-item screening instrument that shows good psychometric properties in TBI populations. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a Likert-type scale from 0 to 3. The total score is the sum across all 20 items. Total scores may range from 0 to 60, with higher scores indicating greater depressive symptoms.

Time frame: 3 - 4 months

Population: Forty-six Veterans were enrolled. After consenting and the baseline interview, 5 were deemed ineligible for the study. Therefore, 41 Veterans were randomized.

ArmMeasureValue (MEAN)Dispersion
Behavioral Activation (BA) Intervention GroupDepressive Symptom Scores on CES-D30.06 units on a scaleStandard Deviation 9.3
Treatment as Usual Control GroupDepressive Symptom Scores on CES-D29.68 units on a scaleStandard Deviation 11.7
Comparison: This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.
Secondary

Community Reintegration Scores on PART-O-17

The Participation Assessment with Recombined Tools-Objective scale (PART-O-17) measures participation in the community in three domains: Productivity, Out and About, and Social Relations. In our study, scores were converted to z scores because more than one response format was used across items. When data are converted to Z scores, the sample mean is always 0. Scores (i.e., Z scores, not standard deviations) above 0 indicate better than average community participation, those below 0 indicate worse participation. Thus, higher scores of this scale indicate better participation.

Time frame: 3 - 4 months

Population: Forty-six Veterans were enrolled. After consenting and the baseline interview, 5 were deemed ineligible for the study. Therefore, 41 Veterans were randomized.

ArmMeasureValue (MEAN)Dispersion
Behavioral Activation (BA) Intervention GroupCommunity Reintegration Scores on PART-O-17.13 Z scoreStandard Deviation 0.38
Treatment as Usual Control GroupCommunity Reintegration Scores on PART-O-17-.11 Z scoreStandard Deviation 0.23
Comparison: This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.
Secondary

Quality of Life in TBI Scores on QoL-TBI Instrument

Quality of life in TBI will be measured by The QoL-TBI instrument. This is a 37-item patient-centered measure that captures the individual's perception of his/her health-related quality-of-life (HRQoL) in cognition, self-care, daily life and autonomy, social relationships, emotions, and physical problems. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a 5-point scale from 0 - Not at all to 4- Very. Although the published description of this tool designates sums across all items as a summary score, we computed the mean of all items. The reason is that the use of a sum poses a problem whenever there are missing data, which produces a spuriously lower score for individuals with some missing responses. Higher scores indicate better quality of life.

Time frame: 3 - 4 months

Population: Forty-six Veterans were enrolled. After consenting and the baseline interview, 5 were deemed ineligible for the study. Therefore, 41 Veterans were randomized.

ArmMeasureValue (MEAN)Dispersion
Behavioral Activation (BA) Intervention GroupQuality of Life in TBI Scores on QoL-TBI Instrument2.05 units on a scaleStandard Deviation 0.47
Treatment as Usual Control GroupQuality of Life in TBI Scores on QoL-TBI Instrument1.92 units on a scaleStandard Deviation 0.4
Comparison: This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.
Other Pre-specified

Acceptability of the Intervention Rated by the Interventionist

Acceptability is measured by the Acceptance/Receipt Scale and is completed by the interventionist at the last intervention session. This is an 18-item tool with Likert scale response formats from 0 to 4. A mean score will be obtained and ranges from 0 to 4. Higher scores indicate increased acceptability.

Time frame: 3 - 4 months

ArmMeasureValue (MEAN)Dispersion
Behavioral Activation (BA) Intervention GroupAcceptability of the Intervention Rated by the Interventionist2.75 units on a scaleStandard Deviation 0.36
Other Pre-specified

Recruitment

Recruitment is considered part of the process domain of feasibility. Recruitment will be measured by the percentage of veterans eligible for the study among those screened and the percentage willing to participate among those screened. Among those screened, our criteria for recruitment is that 50% or more will be eligible for the study and that at least 30% will be willing to participate.

Time frame: 16 months

Population: This is the total number who completed the initial telephone screen. This involved screening for all potential participants prior to randomization.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Behavioral Activation (BA) Intervention GroupRecruitmentNot eligible6 Participants
Behavioral Activation (BA) Intervention GroupRecruitmentConsented46 Participants
Behavioral Activation (BA) Intervention GroupRecruitmentRefused to participate20 Participants
Other Pre-specified

Retention

Retention is considered part of the process domain of feasibility and will be measured in two ways. Retention will be measured by the number of treatment sessions completed over the total number of sessions (6) for only those in the treatment group. The percentage who completed at least four treatment sessions will be the criterion for this. Among those who are enrolled in both groups, retention is measured by the percentage in each group who completed the Time 2 follow-up interview (which occurred 3 - 4 months after the baseline interview).

Time frame: 3 - 4 months for the number in each group that completed the Time 2 follow-up interview and up to 4 months for number in treatment group who completed at least four treatment sessions.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Behavioral Activation (BA) Intervention GroupRetentionRetention - Number in each group that completed the Time 2 follow-up interview16 Participants
Behavioral Activation (BA) Intervention GroupRetentionRetention - Number in treatment group who completed at least four treatment sessions16 Participants
Treatment as Usual Control GroupRetentionRetention - Number in each group that completed the Time 2 follow-up interview19 Participants
Treatment as Usual Control GroupRetentionRetention - Number in treatment group who completed at least four treatment sessions0 Participants
Other Pre-specified

Treatment Fidelity

Treatment fidelity is considered part of the process domain of feasibility. This will be measured by the Treatment Fidelity Checklist, a 15-item tool with a 3-point scale with responses from 1 (poor) to 3 (excellent). The mean will be computed for the 15 items for each recorded interview. The percentage of the interviews that had a mean less than 2.0 will be computed and will be the measure of treatment fidelity. Our criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.

Time frame: 18 months

Population: One transcript of a treatment session for each of 5 participants who received treatment was analyzed. Thus, 5 transcripts were analyzed.

ArmMeasureValue (NUMBER)
Behavioral Activation (BA) Intervention GroupTreatment Fidelity5 number of transcripts with mean < 2.0
Other Pre-specified

Veteran Acceptability/Satisfaction With the Intervention

Acceptability/Satisfaction with the intervention will be measured with the Acceptability/Satisfaction Scale and is completed by the participants who received Behavioral Activation after the last intervention session when the qualitative interview is also conducted. This is a 12 item tool with a Likert scale response format from 0 to 4. A mean score will be obtained and ranges from 0 to 4. A higher score indicates increased acceptability/satisfaction.

Time frame: 3 - 4 months

ArmMeasureValue (MEAN)Dispersion
Behavioral Activation (BA) Intervention GroupVeteran Acceptability/Satisfaction With the Intervention3.34 units on a scaleStandard Deviation 1.59
Comparison: Descriptive statistics are used to describe acceptability/satisfaction for those who received the BA intervention. This tool is completed after the last intervention session when the qualitative interview is also conducted.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026