ACTIVE: Activity Therapy to Increase Veteran Engagement

Browse trials for

• Brain Injuries, Traumatic 1,775
• Depression 8,057

Keywords

• rehabilitation
• depression
• veterans

Brain Injuries, Traumatic

1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.

This study's enrollment of 46 is below the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Study arms

• Experimental
  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: Behavioral Activation · Other: Treatment as Usual

• Other
  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.

  Other: Treatment as Usual

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.

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. 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

Other outcomes

1. 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

2. 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

3. 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

4. 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.

5. 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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Mar 6, 2023
• Informed consent form · Dec 27, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Final data sets underlying all publications resulting from the research will be shared outside VA. A de-identified, anonymized dataset will be created and shared. A final dataset will be made available to the public upon receipt of a study-specific Data Use Agreement made in writing and following IRB and VA R\&D regulations. Data will be provided electronically and per VA regulations for transferring data.

Supporting information: Analytic code