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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RX003382-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Marie Kelly, PhD MS | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | United States | ||
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT |
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.
The data will be available after the project has ended and will be available for seven years after the project has closed.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2026 |
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An independent evaluator will assess outcomes for each study participant.
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| Present-Centered Therapy | Behavioral | 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. |
|
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| 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. | 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. | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
| West Haven |
| Connecticut |
| 06516-2770 |
| United States |
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | United States |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
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| Primary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 61 | 1 | 61 | 2 | 61 |
| EG001 | 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. | 0 | 46 | 4 | 46 | 3 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant admitted to the hospital for chest pain. | Cardiac disorders | Systematic Assessment |
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| Participant hospitalized for strep infection | Infections and infestations | Systematic Assessment |
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| Participant admitted to a hospital for suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Participant admitted to the hospital for a kidney stone | Renal and urinary disorders | Systematic Assessment |
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| Participant admitted to hospital with abdominal pain | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coccyx injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea and diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Epididymitis | Infections and infestations | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Panic attack | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan M. Kelly, Ph.D., Research Investigator, VA Bedford Healthcare System | VA Bedford Healthcare System | 781-687-3317 | Megan.Kelly1@va.gov |
| Jan 21, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2022 | Jun 13, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| 3-month follow-up |
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| 6-month follow-up |
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