Trial Outcomes & Findings for Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD (NCT NCT04567680)
NCT ID: NCT04567680
Last Updated: 2026-02-13
Results Overview
The Social Adjustment Scale-Self Report (SAS-SR) is a 54-item measure of current social functioning in 6 domains: Work; Social and Leisure; Extended Family; Primary Relationship; Parental; and Family Unit. The Social and Leisure scale is the primary measure of change in social functioning for the study. Lower scores indicate better functioning. Scores on this scale range from 1-5.
COMPLETED
NA
107 participants
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
2026-02-13
Participant Flow
Participants were recruited from the VA Bedford Healthcare System, the VA Denver Healthcare System, and the VA Connecticut Healthcare System. Primary sources of recruitment were presentations to mental health services, flyers around the hospitals, tabling events, and targeted mailings to potential participants. Recruitment occurred from March 2021-February 2024.
Potential participants met with study staff to review the informed consent and conduct a baseline intake. Participants who signed consent participated in clinician-rated assessments and completed self-report measures. A detailed inclusion/exclusion criteria checklist was used to determine whether Veterans were eligible for the study. When individuals did not qualify for or chose not to participate in the study, reasons were documented and mental health resources were provided.
Participant milestones
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
46
|
|
Overall Study
COMPLETED
|
51
|
41
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 Participants
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 Participants
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 Years
STANDARD_DEVIATION 15.8 • n=41 Participants
|
53.5 Years
STANDARD_DEVIATION 15.8 • n=1581 Participants
|
52.1 Years
STANDARD_DEVIATION 15.8 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=41 Participants
|
36 Participants
n=1581 Participants
|
87 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=41 Participants
|
36 Participants
n=1581 Participants
|
74 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=41 Participants
|
36 Participants
n=1581 Participants
|
86 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-upThe Social Adjustment Scale-Self Report (SAS-SR) is a 54-item measure of current social functioning in 6 domains: Work; Social and Leisure; Extended Family; Primary Relationship; Parental; and Family Unit. The Social and Leisure scale is the primary measure of change in social functioning for the study. Lower scores indicate better functioning. Scores on this scale range from 1-5.
Outcome measures
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 Participants
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 Participants
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Change in the Social Adjustment Scale-Self Report
Baseline
|
3.384 Units on a Scale
Standard Deviation 0.674
|
3.344 Units on a Scale
Standard Deviation 0.894
|
|
Change in the Social Adjustment Scale-Self Report
End of Treatment (12 weeks)
|
2.974 Units on a Scale
Standard Deviation 0.78
|
2.99 Units on a Scale
Standard Deviation 0.85
|
|
Change in the Social Adjustment Scale-Self Report
3-month follow-up
|
3.15 Units on a Scale
Standard Deviation 0.822
|
3.061 Units on a Scale
Standard Deviation 0.896
|
|
Change in the Social Adjustment Scale-Self Report
6-month follow-up
|
2.842 Units on a Scale
Standard Deviation 0.73
|
3.139 Units on a Scale
Standard Deviation 1.077
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-upSocial Support: The MOS Social Support Survey is a 19-item multidimensional, self-administered survey of social support for individuals with chronic conditions. It includes four functional support scales, including emotional/informational, tangible, affectionate, and positive social interaction. A higher score for an individual scale or for the overall support index indicates more support. Scores range from 1-5.
Outcome measures
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 Participants
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 Participants
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Change in the MOS Social Support Survey
Baseline
|
2.922 Units on a Scale
Standard Deviation 1.057
|
3.061 Units on a Scale
Standard Deviation 1.141
|
|
Change in the MOS Social Support Survey
End of Treatment (12 weeks)
|
3.2 Units on a Scale
Standard Deviation 1.168
|
3.171 Units on a Scale
Standard Deviation 1.138
|
|
Change in the MOS Social Support Survey
3-month follow-up
|
3.1 Units on a Scale
Standard Deviation 1.0
|
3.449 Units on a Scale
Standard Deviation 1.158
|
|
Change in the MOS Social Support Survey
6-month follow-up
|
3.056 Units on a Scale
Standard Deviation 1.097
|
3.093 Units on a Scale
Standard Deviation 1.128
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-upQuality of Life: The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a commonly used self-report measure to assess quality of life in several domains: general activities, physical health, subjective feelings, leisure time activities, social relationships, work, and household duties. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher scores indicate greater life satisfaction and enjoyment.
Outcome measures
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 Participants
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 Participants
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
Baseline
|
39.65 Units on a Scale
Standard Deviation 8.479
|
37.089 Units on a Scale
Standard Deviation 10.231
|
|
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
End of Treatment (12 weeks)
|
46.063 Units on a Scale
Standard Deviation 9.534
|
43.269 Units on a Scale
Standard Deviation 8.384
|
|
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
3-month follow-up
|
46.458 Units on a Scale
Standard Deviation 8.915
|
43.333 Units on a Scale
Standard Deviation 9.178
|
|
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
6-month follow-up
|
46.5 Units on a Scale
Standard Deviation 9.464
|
45.158 Units on a Scale
Standard Deviation 10.642
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-upThe Clinician Administered PTSD Scale (CAPS-5) is a structured interview that will be used to diagnose PTSD and to obtain data (pre and post treatment, follow-up) on the frequency and severity of PTSD symptoms. The CAPS-5 is the gold standard for assessing PTSD. CAPS-5 scores range from 0 to 80 with higher scores indicating greater PTSD symptom severity.
Outcome measures
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 Participants
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 Participants
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Change in the Clinician Administered PTSD Scale (CAPS-5)
Baseline
|
43.441 Units on a Scale
Standard Deviation 11.119
|
43.957 Units on a Scale
Standard Deviation 10.692
|
|
Change in the Clinician Administered PTSD Scale (CAPS-5)
End of Treatment (12 weeks)
|
29.7 Units on a Scale
Standard Deviation 18.734
|
28.04 Units on a Scale
Standard Deviation 13.196
|
|
Change in the Clinician Administered PTSD Scale (CAPS-5)
3-month follow-up
|
27.5 Units on a Scale
Standard Deviation 18.205
|
28.789 Units on a Scale
Standard Deviation 14.972
|
|
Change in the Clinician Administered PTSD Scale (CAPS-5)
6-month follow-up
|
30.571 Units on a Scale
Standard Deviation 18.646
|
24.75 Units on a Scale
Standard Deviation 14.458
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-upThe PCL-5 is a 20-item self-report measure of PTSD symptoms, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items.
Outcome measures
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 Participants
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 Participants
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Change in the PTSD Checklist (PCL-5)
Baseline
|
51.033 Units on a Scale
Standard Deviation 10.313
|
52.109 Units on a Scale
Standard Deviation 10.403
|
|
Change in the PTSD Checklist (PCL-5)
End of Treatment (12 weeks)
|
38.781 Units on a Scale
Standard Deviation 16.576
|
35.308 Units on a Scale
Standard Deviation 13.931
|
|
Change in the PTSD Checklist (PCL-5)
3-month follow-up
|
37.25 Units on a Scale
Standard Deviation 18.774
|
33.826 Units on a Scale
Standard Deviation 16.672
|
|
Change in the PTSD Checklist (PCL-5)
6-month follow-up
|
37.333 Units on a Scale
Standard Deviation 15.846
|
35.632 Units on a Scale
Standard Deviation 18.733
|
Adverse Events
Acceptance and Commitment Therapy to Improve Social Support
Present-Centered Therapy
Serious adverse events
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 participants at risk
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 participants at risk
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Cardiac disorders
Participant admitted to the hospital for chest pain.
|
1.6%
1/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
0.00%
0/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Infections and infestations
Participant hospitalized for strep infection
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Psychiatric disorders
Participant admitted to a hospital for suicidal ideation
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Renal and urinary disorders
Participant admitted to the hospital for a kidney stone
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Infections and infestations
Participant admitted to hospital with abdominal pain
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
Other adverse events
| Measure |
Acceptance and Commitment Therapy to Improve Social Support
n=61 participants at risk
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
|
Present-Centered Therapy
n=46 participants at risk
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Coccyx injury
|
1.6%
1/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
0.00%
0/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Gastrointestinal disorders
Nausea and diarrhea
|
1.6%
1/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
0.00%
0/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/61 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
2.2%
1/46 • Adverse events were collected from enrollment to the 6-month follow-up.
Adverse events were collected by systematic assessment using an adverse events reporting measure.
|
Additional Information
Megan M. Kelly, Ph.D., Research Investigator, VA Bedford Healthcare System
VA Bedford Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place