Trial Outcomes & Findings for ACTIVE: Activity Therapy to Increase Veteran Engagement (NCT NCT04976621)

Last Updated: 2025-12-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

3 - 4 months

Results posted on

2025-12-12

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	22
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

ACTIVE: Activity Therapy to Increase Veteran Engagement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Activation (BA) Intervention Group n=19 Participants 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.	Treatment as Usual Control Group n=22 Participants 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.	Total n=41 Participants Total of all reporting groups
Age, Continuous	47.16 years STANDARD_DEVIATION 14.61 • n=26 Participants	47.32 years STANDARD_DEVIATION 11.11 • n=24 Participants	47.24 years STANDARD_DEVIATION 12.68 • n=50 Participants
Sex: Female, Male Female	2 Participants n=26 Participants	4 Participants n=24 Participants	6 Participants n=50 Participants
Sex: Female, Male Male	17 Participants n=26 Participants	18 Participants n=24 Participants	35 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=26 Participants	1 Participants n=24 Participants	4 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=26 Participants	21 Participants n=24 Participants	37 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	5 Participants n=26 Participants	10 Participants n=24 Participants	15 Participants n=50 Participants
Race (NIH/OMB) White	13 Participants n=26 Participants	10 Participants n=24 Participants	23 Participants n=50 Participants
Race (NIH/OMB) More than one race	1 Participants n=26 Participants	2 Participants n=24 Participants	3 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Region of Enrollment United States	19 Participants n=26 Participants	22 Participants n=24 Participants	41 Participants n=50 Participants
Depressive Symptom Scores on CES-D	35.56 units on a scale STANDARD_DEVIATION 6.45 • n=26 Participants	31.58 units on a scale STANDARD_DEVIATION 6.30 • n=24 Participants	33.78 units on a scale STANDARD_DEVIATION 6.60 • n=50 Participants
Community Reintegration Scores on PART-O-17	.07 Z score STANDARD_DEVIATION .34 • n=26 Participants	-.03 Z score STANDARD_DEVIATION .30 • n=24 Participants	-0.00 Z score STANDARD_DEVIATION .33 • n=50 Participants
Quality of Life in TBI Scores on QoL-TBI Instrument	1.90 units on a scale STANDARD_DEVIATION .31 • n=26 Participants	2.00 units on a scale STANDARD_DEVIATION .40 • n=24 Participants	1.94 units on a scale STANDARD_DEVIATION .36 • n=50 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=16 Participants 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.	Treatment as Usual Control Group n=19 Participants 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.
Depressive Symptom Scores on CES-D	30.06 units on a scale Standard Deviation 9.30	29.68 units on a scale Standard Deviation 11.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=16 Participants 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.	Treatment as Usual Control Group n=19 Participants 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.
Community Reintegration Scores on PART-O-17	.13 Z score Standard Deviation .38	-.11 Z score Standard Deviation .23

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=16 Participants 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.	Treatment as Usual Control Group n=19 Participants 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.
Quality of Life in TBI Scores on QoL-TBI Instrument	2.05 units on a scale Standard Deviation .47	1.92 units on a scale Standard Deviation .40

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 - 4 months

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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=14 Participants 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.	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.
Acceptability of the Intervention Rated by the Interventionist	2.75 units on a scale Standard Deviation .36	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 - 4 months

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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=5 Participants 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.	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.
Veteran Acceptability/Satisfaction With the Intervention	3.34 units on a scale Standard Deviation 1.59	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 months

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

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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=72 Participants 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.	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.
Recruitment Consented	46 Participants	—
Recruitment Refused to participate	20 Participants	—
Recruitment Not eligible	6 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=19 Participants 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.	Treatment as Usual Control Group n=22 Participants 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.
Retention Retention - Number in each group that completed the Time 2 follow-up interview	16 Participants	19 Participants
Retention Retention - Number in treatment group who completed at least four treatment sessions	16 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

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

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.

Outcome measures

Outcome measures
Measure	Behavioral Activation (BA) Intervention Group n=5 5 transcripts of treatment sessions 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.	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.
Treatment Fidelity	5 number of transcripts with mean < 2.0	—

Adverse Events

Behavioral Activation (BA) Intervention Group

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Treatment as Usual Control Group

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Behavioral Activation (BA) Intervention Group n=19 participants at risk 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.	Treatment as Usual Control Group n=22 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Breathing difficulty, diagnosis of acute COPD exacerbation, hospitalized	0.00% 0/19 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
General disorders Injuries from fall (fractured ribs, concussion, and difficulty with hip and ambulation)	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.

Other adverse events

Other adverse events
Measure	Behavioral Activation (BA) Intervention Group n=19 participants at risk 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.	Treatment as Usual Control Group n=22 participants at risk 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.
General disorders non-specific cold symptoms	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Reproductive system and breast disorders abnormal uterine bleeding	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Musculoskeletal and connective tissue disorders back pain	0.00% 0/19 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Injury, poisoning and procedural complications puncture wound of foot (stepped on nail)	0.00% 0/19 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Infections and infestations COVID 19	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Musculoskeletal and connective tissue disorders strained back	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Ear and labyrinth disorders vertigo flare	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Respiratory, thoracic and mediastinal disorders acute cough	0.00% 0/19 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Injury, poisoning and procedural complications cut hand requiring 3 stitches	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Musculoskeletal and connective tissue disorders neck and shoulder pain	0.00% 0/19 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Nervous system disorders migraine	5.3% 1/19 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	0.00% 0/22 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.
Respiratory, thoracic and mediastinal disorders deviated septum	0.00% 0/19 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.	4.5% 1/22 • Number of events 1 • Adverse event data were collected from the time of consent until the final study contact, up to 21 months.

Additional Information

Helene Moriarty, PhD, RN

Corporal Michael J. Crescenz VA Medical Center

Phone: 610-519-5735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place