Trial Outcomes & Findings for One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change (NCT NCT04143243)
NCT ID: NCT04143243
Last Updated: 2025-10-08
Results Overview
The Depression Anxiety and Stress Scale (DASS-21) measure consists of 21 items that measure current symptoms of depression, anxiety, and stress with a total score. It has been used extensively in clinical trials, including those with military populations. Participants are asked to rate the extent to which they have experienced each state over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very much). For total score, scores are summed and range from 0 to 63. Higher total scores indicate more severe symptoms of depression, anxiety and stress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
Through study completion, an average of 6 months following workshop/intervention attendance.
Results posted on
2025-10-08
Participant Flow
OIF/OEF/OND Veterans with deployment-related mTBI, stress-based psychopathology, and pain (polytrauma clinical triad) were recruited from VAMC, outpatient clinics and Veteran Community Organizations.
Eligible participants were randomized at their enrollment following phone screening. They were excluded if imminent risk of suicide.
Participant milestones
| Measure |
ACT on Life
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
|
Education, Resources, and Support
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
86
|
|
Overall Study
COMPLETED
|
83
|
77
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change
Baseline characteristics by cohort
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Depression, Anxiety, and Stress Symptoms (DASS-21) -TOTAL Score
|
33.6 units on a scale
STANDARD_DEVIATION 10.5 • n=5 Participants
|
34.9 units on a scale
STANDARD_DEVIATION 12.0 • n=7 Participants
|
34.3 units on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Military to Civilian Questionnaire (M2C-Q)
|
2.55 units on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
2.53 units on a scale
STANDARD_DEVIATION 0.78 • n=7 Participants
|
2.54 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
|
The PTSD Checklist for DSM-5 (PCL-5)
|
49.7 units on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
|
51.9 units on a scale
STANDARD_DEVIATION 15.4 • n=7 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Defense and Veterans Pain Rating Scale (DVPRS)-Severity
|
6.1 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Acceptance and Action Questionnaire-II (AAQ-II)
|
33.8 units on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 9.5 • n=7 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Valued Living Questionnaire (VLQ)-Success
|
50.0 units on a scale
STANDARD_DEVIATION 21.7 • n=5 Participants
|
52.1 units on a scale
STANDARD_DEVIATION 20.9 • n=7 Participants
|
51.0 units on a scale
STANDARD_DEVIATION 21.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.The Depression Anxiety and Stress Scale (DASS-21) measure consists of 21 items that measure current symptoms of depression, anxiety, and stress with a total score. It has been used extensively in clinical trials, including those with military populations. Participants are asked to rate the extent to which they have experienced each state over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very much). For total score, scores are summed and range from 0 to 63. Higher total scores indicate more severe symptoms of depression, anxiety and stress.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score
|
28.97 units on a scale
Standard Error 1.34
|
30.77 units on a scale
Standard Error 1.38
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report measure used to assess the difficulty veterans experience during the post-deployment reintegration process. A total score is calculated by dividing the sum of the item scores by the number of items the veteran completed (excluding those marked "Does not apply").The Minimum possible score is 0 (if all items are answered as "no difficulty" or "does not apply"). Maximum possible score is 4 (if all items are answered as "extreme difficulty"). Higher scores on the M2CQ indicate greater difficulty with reintegration into civilian life.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
Military to Civilian Questionnaire (M2C-Q)
|
2.296 units on a scale
Standard Error 0.096
|
2.395 units on a scale
Standard Error 0.099
|
SECONDARY outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.The PCL-5 is a 20-item self-report questionnaire to assess post-traumatic stress disorder (PTSD) based on criteria of the Diagnostic and Statistical Manual for Mental Disorders - Version 5 (DSM-5). This scale is available from the National Center for PTSD and is extensively used in Veteran populations. Each item is rated on a 5-point scale with anchors from "not at all" to "extremely" indicating how much the participant has been bothered by the PTSD symptoms in the past month. A total symptom severity score can be obtained by summing the scores for a range of scores from 0 to 80. A higher total score demonstrates more severe PTSD symptoms.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
The PTSD Checklist for DSM-5 (PCL-5)
|
42.38 units on a scale
Standard Error 1.94
|
47.36 units on a scale
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool that assesses severity of pain. It uses a numerical scale ranging from 0 to 10 to assess pain intensity. Minimum Score: 0, representing "No pain". Maximum Score: 10, representing "As bad as pain can be, nothing else matters". It is a reliable and valid instrument developed for use in military populations.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
Defense and Veterans Pain Rating Scale (Pain Severity)
|
5.77 units on a scale
Standard Error 0.20
|
5.87 units on a scale
Standard Error 0.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.The Acceptance and Action Questionnaire-II (AAQ-II) is an ACT-specific self-report measure of psychological inflexibility. The AAQ was designed to measure mechanisms hypothesized to be at work in ACT treatments and has been found to mediate behavioral outcomes in ACT interventions. Seven items are rated on a 7-point scale, ranging from 1 ("never true") to 7 ("always true"), with higher scores reflecting greater levels of psychological inflexibility. The total score is calculated by summing the ratings for each of the seven items. The minimum possible score is 7 (7 items x 1 point each).The maximum possible score is 49 (7 items x 7 points each). Higher total scores indicate greater levels of psychological inflexibility and experiential avoidance.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
Acceptance and Action Questionnaire-II
|
30.10 units on a scale
Standard Error 1.18
|
30.78 units on a scale
Standard Error 1.23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.Valued Living Questionnaire (VLQ) is a self-report measure that assesses engagement in valued areas of life. Participants first rate the importance of 10 life domains (e.g., family, work, friends etc.) on a 10-point Likert scale (1 = not at all important to 10 = extremely important). They then rate the degree to which their actions over the past week were consistent with each value, from 1 (not at all consistent) to 10 (extremely consistent). The "success" score is the VLQ Composite Score and refers to the composite score that measures how consistently a person is living in accordance with their stated personal values. The Valued Living composite is calculated by multiplying the Importance and Consistency responses for each domain and then calculating the mean of those scores. The resulting Valued Living Composite scores can range from 10-100. A higher score indicates greater alignment between actions and values, which is associated with positive psychological outcomes.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
Valued Living Questionnaire (VLQ) - Success
|
48.80 units on a scale
Standard Error 2.38
|
51.54 units on a scale
Standard Error 2.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 6 months following workshop/intervention attendance.The outcome measure is either Yes or No and then we computed the percentage of study participants that responded 'yes' on having utilized services for emotional problems from any of the following, medical provider, spiritual provider(priest/minister), psychiatric help or had hospital admission(in or outpatient) or ER admission.
Outcome measures
| Measure |
ACT on Life
n=90 Participants
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 Participants
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
Self-reported Service Utilization (Emotional Problems)
|
54 Participants
|
44 Participants
|
Adverse Events
ACT on Life
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Education, Resources, and Support
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACT on Life
n=90 participants at risk
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life').
The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
ACT on Life: 1 day group workshop of ACT plus ERS
|
Education, Resources, and Support
n=86 participants at risk
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered
Education, Resources, and Support: 1 day group workshop of Education, Resources, and Support
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
2.2%
2/90 • Through study completion, up to 6 months following workshop attendance.
This is a low-risk study. The investigators are simply providing a workshop to Veterans to teach them more about their difficulties and new ways they may cope. However, if at any time during the study we obtained information about significant and imminent suicidality, we would follow-up by doing a suicide risk assessment and making immediate referrals.
|
2.3%
2/86 • Through study completion, up to 6 months following workshop attendance.
This is a low-risk study. The investigators are simply providing a workshop to Veterans to teach them more about their difficulties and new ways they may cope. However, if at any time during the study we obtained information about significant and imminent suicidality, we would follow-up by doing a suicide risk assessment and making immediate referrals.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place