Trial Outcomes & Findings for One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology (NCT NCT02844946)
NCT ID: NCT02844946
Last Updated: 2021-12-02
Results Overview
Quality of Life. The general Quality of Life scale includes 2 items that measure overall QOL and general health. Items scored are scored from 1-5 so the range for the this scale is 2-10 with higher scores representing higher quality of life.
COMPLETED
NA
39 participants
Through study completion, an average of 3 months following workshop attendance
2021-12-02
Participant Flow
Participant milestones
| Measure |
ACT on Life
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
Veterans will continue receiving care as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
12
|
|
Overall Study
COMPLETED
|
20
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
ACT on Life
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
Veterans will continue receiving care as usual.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
0
|
Baseline Characteristics
One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
Baseline characteristics by cohort
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
World Health Organization-Quality of Life (WHO-QOL)
|
6.11 units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
5.17 units on a scale
STANDARD_DEVIATION 1.90 • n=7 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
The Depression Anxiety and Stress Scale (DASS-21)
|
53.4 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
59.7 units on a scale
STANDARD_DEVIATION 8.0 • n=7 Participants
|
55.1 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
The Brief Pain Inventory (BPI) Severity
|
5.5 units on a scale
STANDARD_DEVIATION .4 • n=5 Participants
|
4.5 units on a scale
STANDARD_DEVIATION .5 • n=7 Participants
|
5.0 units on a scale
STANDARD_DEVIATION .4 • n=5 Participants
|
|
World Health Organization Disability Assessment Schedule II (WHODAS-II)
|
40.9 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
40.8 units on a scale
STANDARD_DEVIATION 7.1 • n=7 Participants
|
40.9 units on a scale
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Military to Civilian Questionnaire (M2C-Q)
|
2.0 units on a scale
STANDARD_DEVIATION .21 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION .27 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION .23 • n=5 Participants
|
|
PTSD Checklist-Civilian Version (PCL-C)
|
56.3 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
56.2 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
56.2 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Acceptance and Action Questionnaire-II (AAQ-II)
|
27.3 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
28.4 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
Quality of Life. The general Quality of Life scale includes 2 items that measure overall QOL and general health. Items scored are scored from 1-5 so the range for the this scale is 2-10 with higher scores representing higher quality of life.
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
World Health Organization-Quality of Life (WHO-QOL)
|
6.11 units on a scale
Standard Error 1.94
|
5.20 units on a scale
Standard Error 1.55
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
Consists of three self-report scales that measure current depression, anxiety, and stress. This 21-item measure consists of three self-report scales that measure current symptoms of depression, anxiety, and stress and a total score. It has been used extensively in clinical trials, including those with military populations. Higher scores represent greater distress and scores range from 0-126.
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS-21)
|
42.7 units on a scale
Standard Error 6.3
|
65.6 units on a scale
Standard Error 8.3
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
Assesses the severity of pain and the impact of pain on daily functions. The BPI severity scale assesses pain at its "worst," "least," "average," and "now" (current pain). A composite of the four pain items (a mean severity score) is used here as recommended for assessing pain in clinical trials. Higher scores represent greater severity (0-10).
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
Brief Pain Inventory (BPI)
|
5.3 units on a scale
Standard Deviation .5
|
4.2 units on a scale
Standard Deviation .7
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
Assesses functioning and disability due to health conditions. Six domains are covered: understanding and communicating, getting around, self-care, getting along with people, life act. This is a self-report measure that assesses behavioral and functional impairments as a separate domain from disease symptoms. Higher scores indicate higher disability (from 0-100).
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
World Health Organization Disability Assessment Schedule II (WHODAS-II)
|
38.3 units on a scale
Standard Error 5.6
|
41.7 units on a scale
Standard Error 7.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
This 16-item self-report measure assesses post-deployment difficulties with reintegration during the previous month. Respondents rate the level of difficulty on a 5-point scale from No Difficulty to Extreme Difficulty (0-4). The following domains are covered by the M2C-Q: Social relations, community engagement, perceived meaning in life, self-care and leisure, and parenting. The total score is the average of the 16 items. Higher scores reflecting greater difficulty with reintegration.
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
Military to Civilian Questionnaire (M2C-Q)
|
1.81 units on a scale
Standard Error .22
|
2.14 units on a scale
Standard Error .30
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
PCL-C is a 17-item self-report questionnaire assessing the presence and severity of DSM-IV symptoms of PTSD during the past month. All items are added for a total severity score. Higher scores represent greater severity of PTSD symptoms. Scores range from 1-85.
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
PTSD Checklist-Civilian Version (PCL-C)
|
49.2 units on a scale
Standard Error 3.8
|
54.4 units on a scale
Standard Error 4.8
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 months following workshop attendancePopulation: 27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.
The AAQ-II is an ACT-specific self-report measure of psychological inflexibility. Seven items are rated on a 7-point scale, ranging from 1 ("never true") to 7 ("always true"), with higher scores reflecting greater inflexibility. Scores range from 1-49. Example items include, "Emotions cause problems in my life," and "My painful memories prevent me from having a fulfilling life." It has been shown to have good internal consistency and validity and also to mediate behavioral outcomes in ACT interventions.
Outcome measures
| Measure |
ACT on Life
n=19 Participants
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life?s challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Acceptance and Commitment Therapy: Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
|
Treatment as Usual
n=12 Participants
Veterans will continue receiving care as usual.
|
|---|---|---|
|
Acceptance and Action Questionnaire-II (AAQ-II)
|
22.8 units on a scale
Standard Error 2.8
|
30.3 units on a scale
Standard Error 3.8
|
Adverse Events
ACT on Life
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place