Posttraumatic Stress DisorderNCT05187156
Assessing and Enhancing Social Support
A study testing Behavioral Activation and Social Engagement and Treatment as usual in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Behavioral Activation and Social Engagement and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Behavioral Activation and Social Engagement, Treatment as usual
- Keywords
- Stress Disorders, Post-Traumatic, Social Support
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation and Social EngagementBehavioural
brief, PCMHI-based psychotherapy using behavioral activation principles and focused attention on enhancement of social support
Treatment as usualBehavioural
treatment as usual in PCMHI includes participation in any other skills-based groups or brief individual psychotherapy and medication management offered in PCMHI
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Veterans will participate in a novel intervention to improve PTSD and social support Receives: Behavioral: Behavioral Activation and Social Engagement |
| Treatment as usual | Active comparator | Veterans will participate in usual care in PCMHI Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent completing treatment
number completing treatment/number enrolled (ratio of the two variables)
Measured: Up to 16 weeks
Secondary outcomes (5)
Percentage declined participation
number enrolled/number approached (ratio of the two variables)
Measured: up to 16 weeks
PTSD Checklist for DSM-5
Scores range from 0-80 with lower scores indicating lower levels of symptoms
Measured: change from baseline to up to 20 weeks
PROMIS Depression Short Form 8
Scores range from 8-40 with lower scores indicating lower levels of symptoms
Measured: change from baseline to up to 20 weeks
Change in social support
Instrument to be selected based on results of qualitative interviews
Measured: change from baseline to up to 20 weeks
Interpersonal Needs Questionnaire - Thwarted Belongingness Subscale
Scores range from 10-70 with lower scores indicating higher levels of social connection
Measured: change from baseline to up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Feb 2023
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: The PI has transitioned to working outside of the VA - study will not continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah B Campbell, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187156
- Sponsor's protocol ID
- CDX 22-004
- Other IDs
- CDA 19-208
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Enhancing Social Support to Improve Treatment Outcomes Among Veterans With PTSD (CDA 19-208)
- ClinicalTrials.gov ID
- NCT05187156
- Acronym / sponsor ID
- CDX 22-004
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Stress Disorders, Post-Traumatic, Social Support
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI has transitioned to working outside of the VA - study will not continue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behavioral Activation and Social EngagementVeterans will participate in a novel intervention to improve PTSD and social support |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualVeterans will participate in usual care in PCMHI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Behavioral Activation and Social Engagementbrief, PCMHI-based psychotherapy using behavioral activation principles and focused attention on enhancement of social support | Behavioural | Intervention |
| Treatment as usualtreatment as usual in PCMHI includes participation in any other skills-based groups or brief individual psychotherapy and medication management offered in PCMHI | Behavioural | Treatment as usual |
Primary outcome
Percent completing treatment
Time frame: Up to 16 weeks
number completing treatment/number enrolled (ratio of the two variables)
5 secondary outcomes
Percentage declined participation
Time frame: up to 16 weeks
PTSD Checklist for DSM-5
Time frame: change from baseline to up to 20 weeks
PROMIS Depression Short Form 8
Time frame: change from baseline to up to 20 weeks
Change in social support
Time frame: change from baseline to up to 20 weeks
Interpersonal Needs Questionnaire - Thwarted Belongingness Subscale
Time frame: change from baseline to up to 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Sarah B Campbell, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Social Engagement and Treatment as usual in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent completing treatment (time frame: Up to 16 weeks). 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 15 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.