Post-traumatic Stress DisorderACT-SSNCT04567680
Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
A study testing Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD and Present-Centered Therapy in people with Post-traumatic Stress Disorder, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
Veterans with PTSD often have impaired social relationships and poor social support. The negative outcomes associated with poor social support are of particular concern for Veterans with PTSD, who often perceive the world to be dangerous, view their social support network as a threat to their safety, and avoid members… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD and Present-Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2021to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current DSM-5 PTSD diagnosis
- Minimum score of 31 on the PCL-5
- Clinically significant difficulties in interpersonal relationships
- Competent to provide written informed consent
- Ages 18 and older
- If being treated with psychoactive medication, no change in drugs or dose for the past 2 months
- Willingness to be audio-taped
Who cannot join
- Any current or lifetime DSM-5 psychotic disorder
- Current or recent (within 1 month of study entry) DSM-5 substance use disorder
- Cognitive impairment that would interfere with study participation
- Current manic episode
- Recent clinically significant suicidality (past 3 months)
- Moderate to severe domestic violence (measured by the Conflict Tactics Scale-2)
- Current PTSD psychotherapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Veterans with PTSD often have impaired social relationships and poor social support. The negative outcomes associated with poor social support are of particular concern for Veterans with PTSD, who often perceive the world to be dangerous, view their social support network as a threat to their safety, and avoid members of their support network in order to increase their perceived safety. The goal of this project is to evaluate the efficacy of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a treatment focused on helping Veterans with PTSD to increase social support with family relationships, partners, and peers by targeting maladaptive patterns of interpersonal difficulties, feelings of detachment from others, irritability, and avoidance of social situations. The primary aim of this study is to conduct a two-site randomized controlled trial of ACT-SS (n=75) vs. PCT (n=75), a common treatment for social support difficulties. If positive, this study will provide a critically-needed treatment for Veterans with PTSD to improve their social functioning and social reintegration in the community.
Read the detailed description
Veterans with PTSD often have substantial interpersonal problems and low perceived social support from family, partners, and peers. Interpersonal problems result in poor social reintegration, which in turn permeates all aspects of their functioning and is associated with greater suicidal ideation. The problems emerge rapidly, with one study showing a fourfold increase in rates of self-reported interpersonal conflict within six months of returning from deployment. Veterans with PTSD report considerable avoidance in relationships, marital stress, intimacy difficulties, and parenting problems. Low social support is a key factor related to poor physical health, emotional functioning, and increased mortality risk. Given the importance of social relationships in buffering against negative outcomes and suicidal ideation for persons with PTSD, there is a strong need for more research and treatment development to improve the social functioning of these Veterans. The proposed project will focus on evaluating an innovative treatment for improving the social relationships and social support among Veterans with PTSD.
The goal of this project is to evaluate the efficacy of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a treatment focused on helping Veterans with PTSD to increase social support with family relationships, partners, and peers by targeting maladaptive patterns of interpersonal difficulties, feelings of detachment from others, irritability, and avoidance of social situations. ACT-SS provides Veterans with PTSD with more adaptive coping skills (i.e., acceptance and mindfulness, focus on values-based living) to improve social relationships, social support, and help manage PTSD-related distress. The investigators' pilot data of ACT-SS indicates that ACT-SS results in improved social relationships and reduced PTSD symptoms, with preliminary data showing that ACT-SS results in significantly better improvement in social functioning outcomes compared to Present-Centered Therapy (PCT).
The primary aim of this study is to conduct a two-site randomized controlled trial of ACT-SS (n=75) vs. PCT (n=75), a common treatment for social support difficulties. Study outcomes will include measures of social support, social relationships, quality of life, and PTSD symptoms. This proposal, supported by the promising pilot data, represents an important step in examining the potential efficacy of ACT-SS, including social functioning and quality of life in Veterans with PTSD. If positive, results from this study may provide a new treatment approach for improving the social reintegration of Veterans with PTSD.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD, Present-Centered Therapy
- Keywords
- PTSD, Social Support, Veterans, Social Functioning, Community Reintegration
- Medical subject headings
- Stress Disorders, Post-Traumatic, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSDBehavioural
Also called ACT-SS
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 TherapyBehavioural
Also called PCT
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy to Improve Social Support | Experimental | 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. Receives: Behavioral: Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD |
| Present-Centered Therapy | Active comparator | 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. Receives: Behavioral: Present-Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Social Adjustment Scale-Self Report
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.
Measured: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the MOS Social Support Survey
Social 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.
Measured: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Secondary outcomes (3)
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
Quality 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.
Measured: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the Clinician Administered PTSD Scale (CAPS-5)
The 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.
Measured: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the PTSD Checklist (PCL-5)
The 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.
Measured: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Mar 2021
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Megan Marie Kelly, PhD MS, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567680
- Sponsor's protocol ID
- D3382-R
- Other IDs
- 1I01RX003382-01A1
- Acronym
- ACT-SS
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2020
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets from the study, composed of de-identified data, will be archived and available to others by request to the PI. All publications from this study will be made available to the public through the National Library of Medicine PubMed Central website within one year after the research article is published.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT04567680
- Acronym / sponsor ID
- ACT-SS / D3382-R
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- PTSD, Social Support, Veterans, Social Functioning, Community Reintegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans with PTSD often have impaired social relationships and poor social support. The negative outcomes associated with poor social support are of particular concern for Veterans with PTSD, who often perceive the world to be dangerous, view their social support network as a threat to their safety, and avoid members of their support network in order to increase their perceived safety. The goal of this project is to evaluate the efficacy of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a treatment focused on helping Veterans with PTSD to increase social support with family relationships, partners, and peers by targeting maladaptive patterns of interpersonal difficulties, feelings of detachment from others, irritability, and avoidance of social situations. The primary aim of this study is to conduct a two-site randomized controlled trial of ACT-SS (n=75) vs. PCT (n=75), a common treatment for social support difficulties. If positive, this study will provide a critically-needed treatment for Veterans with PTSD to improve their social functioning and social reintegration in the community.
Detailed description
Veterans with PTSD often have substantial interpersonal problems and low perceived social support from family, partners, and peers. Interpersonal problems result in poor social reintegration, which in turn permeates all aspects of their functioning and is associated with greater suicidal ideation. The problems emerge rapidly, with one study showing a fourfold increase in rates of self-reported interpersonal conflict within six months of returning from deployment. Veterans with PTSD report considerable avoidance in relationships, marital stress, intimacy difficulties, and parenting problems. Low social support is a key factor related to poor physical health, emotional functioning, and increased mortality risk. Given the importance of social relationships in buffering against negative outcomes and suicidal ideation for persons with PTSD, there is a strong need for more research and treatment development to improve the social functioning of these Veterans. The proposed project will focus on evaluating an innovative treatment for improving the social relationships and social support among Veterans with PTSD.
The goal of this project is to evaluate the efficacy of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a treatment focused on helping Veterans with PTSD to increase social support with family relationships, partners, and peers by targeting maladaptive patterns of interpersonal difficulties, feelings of detachment from others, irritability, and avoidance of social situations. ACT-SS provides Veterans with PTSD with more adaptive coping skills (i.e., acceptance and mindfulness, focus on values-based living) to improve social relationships, social support, and help manage PTSD-related distress. The investigators' pilot data of ACT-SS indicates that ACT-SS results in improved social relationships and reduced PTSD symptoms, with preliminary data showing that ACT-SS results in significantly better improvement in social functioning outcomes compared to Present-Centered Therapy (PCT).
The primary aim of this study is to conduct a two-site randomized controlled trial of ACT-SS (n=75) vs. PCT (n=75), a common treatment for social support difficulties. Study outcomes will include measures of social support, social relationships, quality of life, and PTSD symptoms. This proposal, supported by the promising pilot data, represents an important step in examining the potential efficacy of ACT-SS, including social functioning and quality of life in Veterans with PTSD. If positive, results from this study may provide a new treatment approach for improving the social reintegration of Veterans with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy to Improve Social Support | Experimental | Behavioral: Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSDThis 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 | Active comparator | Behavioral: Present-Centered TherapyPCT 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Current DSM-5 PTSD diagnosis
- Minimum score of 31 on the PCL-5
- Clinically significant difficulties in interpersonal relationships
- Competent to provide written informed consent
- Ages 18 and older
Key exclusion criteria (7 listed)
- Any current or lifetime DSM-5 psychotic disorder
- Current or recent (within 1 month of study entry) DSM-5 substance use disorder
- Cognitive impairment that would interfere with study participation
- Current manic episode
- Recent clinically significant suicidality (past 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSDAlso: ACT-SSThis 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. | Behavioural | Acceptance and Commitment Therapy to Improve Social Support |
| Present-Centered TherapyAlso: PCTPCT 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. | Behavioural | Present-Centered Therapy |
Primary outcome
Change in the Social Adjustment Scale-Self Report
Time frame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
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.
Change in the MOS Social Support Survey
Time frame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Social 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.
3 secondary outcomes
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
Time frame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the Clinician Administered PTSD Scale (CAPS-5)
Time frame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the PTSD Checklist (PCL-5)
Time frame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Final data sets from the study, composed of de-identified data, will be archived and available to others by request to the PI. All publications from this study will be made available to the public through the National Library of Medicine PubMed Central website within one year after the research article is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Marie Kelly, PhD MS principal investigator
VA Bedford HealthCare System, Bedford, MA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD and Present-Centered Therapy in people with Post-traumatic Stress Disorder, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Social Adjustment Scale-Self Report (time frame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.