- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187156
Assessing and Enhancing Social Support
February 13, 2023 updated by: VA Office of Research and Development
Assessing and Enhancing Social Support to Improve Treatment Outcomes Among Veterans With PTSD (CDA 19-208)
Posttraumatic stress disorder (PTSD) is a common and impairing problem among Veterans, many of whom first seek treatment in primary care settings.
PTSD is linked to reduced quality of life and increased rates of suicide.
Additionally, social support, defined as the availability of others to provide emotional or practical support when needed, is frequently poor for Veterans with PTSD.
For Veterans with PTSD, poor social support negatively impacts PTSD treatment engagement and outcomes, interfering with PTSD recovery.
There is a need for additional brief, primary care-based treatments for PTSD that also work to improve social support in traumatized Veterans.
The proposed research seeks to evaluate and refine such an intervention and establish a protocol for routinely measuring social support to inform treatment.
This intervention and measurement protocol will likely improve Veterans' mental health and social relationships.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Background: PTSD is a significant problem for Veterans, most of whom are initially treated for posttraumatic stress disorder (PTSD) in Primary Care Mental Health Integration (PCMHI).
Poor social support in this population is a risk factor for suicidal ideation, all-cause mortality, and worse treatment engagement and response.
Preliminary research shows that approximately 60% of Veterans with PTSD present to specialty care intake appointments with poor social support.
However, none of the existing PCMHI-based treatments for PTSD explicitly focus on social support generation or reengagement.
Moreover, although the limited existing research suggests that the routine assessment of social support to guide treatment planning (also known as measurement-based care, or MBC) improves treatment outcomes in civilian populations, social support is not routinely monitored as part of evidence-based treatments for PTSD.
Thus, this CDA-2 will first identify an appropriate instrument for routinely measuring social support in the context of clinical care to improve PTSD treatment, and, subsequently, evaluate a novel PCMHI-based PTSD treatment as part of a stepped care model for Veterans who report poor social support and are at great risk of PTSD treatment non-response.
Significance/Impact: The proposed research addresses several HSR&D research priorities, including evaluating the impact of social determinants of health, namely, social support, on the quality and outcomes of care; testing new models of mental health care to improve outcomes; and intervening with vulnerable Veterans with PTSD and suicide risk.
By measuring and improving social support to enhance PTSD treatment, the proposed research plan explicitly addresses a key factor that impedes treatment outcomes for a sensitive population of Veterans.
Innovation: Although poor social support is widely recognized as among the strongest predictors of PTSD development and maintenance, none of the existing PCMHI-based treatments for PTSD target or measure social support as a primary treatment focus.
The proposed CDA-2 research is thus highly novel.
No past or present HSR&D-funded studies have tested methods for monitoring or improving social support in PCMHI-based treatment among Veterans with PTSD, despite its association with poor clinical outcomes.
Specific Aims: 1) Select an instrument for MBC of social support in clinical settings for Veterans with PTSD.
2) Iteratively refine and conduct a one-arm pilot test a brief, PCMHI-based behavioral activation and social engagement intervention for PTSD based on key stakeholder (e.g., Veteran and PCMHI provider) feedback.
3) Conduct a two-arm pilot randomized clinical trial (RCT) comparing the intervention to usual care in PCMHI.
Methodology: Aim 1 will use quantitative data gathered in an online survey from 210 Veterans to assess the degree to which four measures of social support (identified via systematic review and clinical utility ranking) are acceptable, reliable, and sensitive, and select the best measure for use in Aim 2's pilot.
Aim 2 will involve the iterative refinement of the PTSD and social support intervention following, and followed by, qualitative interviews with key stakeholders.
Aim 2 will obtain data on participant acceptability, provider fidelity, and social-support-related MBC.
The pilot RCT comparing the social support and PTSD intervention to usual care in Aim 3 will evaluate the feasibility and acceptability of recruitment, randomization, intervention engagement, evaluation strategy, and outcome measurement of clinical outcomes (e.g., PTSD, depression symptoms, and social support), as well as mechanisms of change (e.g., disclosure) and multiple stepped-care outcomes (e.g., clinically-indicated evidence-based psychotherapy initiation/retention).
Next Steps/Implementation: This work will support future trials establishing effectiveness and implementation potential of the intervention, as well as a model of MBC of social support.
Future research will explore MBC and PCMHI-based interventions for poor social support in related conditions.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah B Campbell, PhD
- Phone Number: (206) 716-5789
- Email: sarah.campbell6@va.gov
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108-1532
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Veterans will be eligible for participation if they:
- are currently enrolled in a Primary Care Clinic at VA Puget Sound Health Care System (VAPSHCS) (including Women's Clinic) or VAPSHCS Primary Care Mental Health Integration (PCMHI)
- meet criteria for clinical or subclinical PTSD consistent with PTSD treatment in PCMHI defined as > 33 on the PTSD Checklist for DSM 5 (PCL-5)
- are willing to have therapy sessions audiotaped for the purposes of fidelity assessment
- plan to live in Washington state for 6 months following entry into the study to prevent delivery of care across state lines
Exclusion Criteria:
- presence of severe mental illness (e.g., active psychosis and/or bipolar disorder)
- a psychiatric in-patient admission in the past 30 days
- medical record suicide flag
- a behavioral flag in the medical record
- individuals with impaired decision making capacity (as measured by evidence in the medical record of moderate-severe TBI, uncontrolled psychosis, dementia, communication flag, or inability to provide informed consent)
- individuals who are illiterate or have limited or no English proficiency
- medication change in the last month
- current or recent (last 6 months) participation in specialty mental health
- current participation in CPT or PE, to ensure that Veterans are representative of PCMHI
Inclusion/exclusion criteria will be assessed via chart review.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Veterans will participate in a novel intervention to improve PTSD and social support
|
brief, PCMHI-based psychotherapy using behavioral activation principles and focused attention on enhancement of social support
|
Active Comparator: Treatment as usual
Veterans will participate in usual care in PCMHI
|
treatment as usual in PCMHI includes participation in any other skills-based groups or brief individual psychotherapy and medication management offered in PCMHI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent completing treatment
Time Frame: Up to 16 weeks
|
number completing treatment/number enrolled (ratio of the two variables)
|
Up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage declined participation
Time Frame: up to 16 weeks
|
number enrolled/number approached (ratio of the two variables)
|
up to 16 weeks
|
PTSD Checklist for DSM-5
Time Frame: change from baseline to up to 20 weeks
|
Scores range from 0-80 with lower scores indicating lower levels of symptoms
|
change from baseline to up to 20 weeks
|
PROMIS Depression Short Form 8
Time Frame: change from baseline to up to 20 weeks
|
Scores range from 8-40 with lower scores indicating lower levels of symptoms
|
change from baseline to up to 20 weeks
|
Change in social support
Time Frame: change from baseline to up to 20 weeks
|
Instrument to be selected based on results of qualitative interviews
|
change from baseline to up to 20 weeks
|
Interpersonal Needs Questionnaire - Thwarted Belongingness Subscale
Time Frame: change from baseline to up to 20 weeks
|
Scores range from 10-70 with lower scores indicating higher levels of social connection
|
change from baseline to up to 20 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Counts of outpatient mental health visits by type
Time Frame: number occurring between up to 16 weeks and up to 40 weeks
|
Number of specialty care encounters including medication management and psychotherapy
|
number occurring between up to 16 weeks and up to 40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
February 1, 2023
Study Completion (Actual)
February 1, 2023
Study Registration Dates
First Submitted
December 23, 2021
First Submitted That Met QC Criteria
December 23, 2021
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDX 22-004
- CDA 19-208 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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