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Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD (ACT-SS)

Primary Purpose

Post-traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD
Present-Centered Therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, Social Support, Veterans, Social Functioning, Community Reintegration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CORecruiting
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting
  • VA Bedford HealthCare System, Bedford, MARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance and Commitment Therapy to Improve Social Support

Present-Centered Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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. It is the primary measure of change in social functioning for the study. An Overall Adjustment scale provides a total score (alpha = .74-.85; test-retest r's = .78-.80). The SAS-SR is sensitive to change and has good convergent and discriminant validity. Higher scores indicate better functioning. Scores for each role area are calculated by averaging the scores for all answered items within that area. The total score is calculated by averaging all applicable items.
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. Scores range from 0-100. A higher score for an individual scale or for the overall support index indicates more support.

Secondary Outcome Measures

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. Percent maximum scores range from 0-100. Higher scores indicating greater life satisfaction and enjoyment.
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.
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.

Full Information

First Posted
September 23, 2020
Last Updated
March 15, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04567680
Brief Title
Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
Acronym
ACT-SS
Official Title
Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
PTSD, Social Support, Veterans, Social Functioning, Community Reintegration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
An independent evaluator will assess outcomes for each study participant.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy to Improve Social Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Present-Centered Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD
Other Intervention Name(s)
ACT-SS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Present-Centered Therapy
Other Intervention Name(s)
PCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Social Adjustment Scale-Self Report
Description
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. It is the primary measure of change in social functioning for the study. An Overall Adjustment scale provides a total score (alpha = .74-.85; test-retest r's = .78-.80). The SAS-SR is sensitive to change and has good convergent and discriminant validity. Higher scores indicate better functioning. Scores for each role area are calculated by averaging the scores for all answered items within that area. The total score is calculated by averaging all applicable items.
Time Frame
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Title
Change in the MOS Social Support Survey
Description
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. Scores range from 0-100. A higher score for an individual scale or for the overall support index indicates more support.
Time Frame
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
Description
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. Percent maximum scores range from 0-100. Higher scores indicating greater life satisfaction and enjoyment.
Time Frame
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Title
Change in the Clinician Administered PTSD Scale (CAPS-5)
Description
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.
Time Frame
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Title
Change in the PTSD Checklist (PCL-5)
Description
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.
Time Frame
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan M Kelly, PhD MS
Phone
(857) 364-6196
Email
megan.kelly1@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Erin D Reilly, PhD
Phone
(781) 687-4191
Email
Erin.Reilly@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Marie Kelly, PhD MS
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryann DeBeer, PhD
Phone
917-208-1071
Email
Bryann.DeBeer@va.gov
First Name & Middle Initial & Last Name & Degree
Taylor Phillips, MA
Phone
7207236493
Email
Taylor.Phillips2@va.gov
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert MacLean, PhD
Phone
203-932-5711
Ext
7423
Email
Robert.MacLean@va.gov
Facility Name
VA Bedford HealthCare System, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730-1114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan M Kelly, PhD MS
Phone
(857) 364-6196
Email
megan.kelly1@va.gov
First Name & Middle Initial & Last Name & Degree
Paula Mroz, PhD
Phone
(781) 687-3299
Email
paula.mroz@va.gov
First Name & Middle Initial & Last Name & Degree
Megan Marie Kelly, PhD MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available after the project has ended and will be available for seven years after the project has closed.

Learn more about this trial

Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD

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