Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Loved one assisted treatment
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Couples therapy, Psychotherapy, Veterans
Eligibility Criteria
Inclusion Criteria:
- Enrolled in VHA care
- Clinically significant PTSD symptoms
- Have a LO (loved one/intimate partner) with whom they have been in a romantic relationship with for 6 months
- Will allow a LO to participate
- Willing to be seen via telehealth when in-person treatment options aren't available.
Exclusion Criteria:
- Actively suicidal/homicidal with intent and/or plan
- Episode of mania/ psychosis in past 3 months
- Severe substance use problem in past 3 months
- Moderate relationship violence
- Veteran has underlying medical condition or a planned medical procedure likely to impair ability to engage in treatment.
- LO screens positive for PTSD
- Veteran and/or LO fails to complete baseline survey
Sites / Locations
- Atlanta VA Medical and Rehab Center, Decatur, GA
- VA Ann Arbor Healthcare System, Ann Arbor, MI
- Minneapolis VA Health Care System, Minneapolis, MN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Loved one assisted treatment
Arm Description
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale for DSM-5 to assess changes in PTSD symptoms. Scores range from 0 to 80, with higher scores indicating worse outcomes
Structured clinical interview assessing symptoms of PTSD
Secondary Outcome Measures
Full Information
NCT ID
NCT04241094
First Posted
January 22, 2020
Last Updated
August 18, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04241094
Brief Title
Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
Official Title
Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
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
No
5. Study Description
Brief Summary
PTSD occurs in as many as 17% of US military Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. EBPs, such as Prolonged Exposure, result in clinically significant symptom relief for many. Yet, these therapies have proven less effective for military personnel and Veterans and treatment dropout rates are high. The investigators' team surveyed Veterans initiating EBPs for PTSD and a family member across four VA medical centers (N = 598; Project HomeFront). The investigators found that Veterans were more than twice as likely to complete EBPs when loved ones encouraged them to confront distress and that Veterans experienced greater treatment gains when they shared more with their loved ones about their treatment. A couples-based, exposure therapy for PTSD that integrates intimate partners into every session of PE could provide the opportunity to mobilize the whole household in the service of EBP engagement, while extending the goals of therapy beyond symptom reduction to family functioning. The investigators anticipate this intervention will teach couples to embrace a lifestyle that supports confronting trauma-related distress, so the Veteran and his/her family can achieve optimal functional outcomes.
Detailed Description
The investigators aim to improve the mental health, family functioning, and well-being of Veterans with posttraumatic stress disorder (PTSD) through developing and evaluating a trauma-focused, couple therapy for PTSD. The investigators will use strategies from Integrative Behavioral Couple Therapy (ICBT) to help intimate partners support Veterans during exposure therapy for PTSD (Prolonged Exposure; PE). The investigators anticipate this approach will increase Veterans' engagement in PE, but also improve relationship functioning, family functioning, and social functioning. Family involvement has been highlighted as a fertile avenue for improving the outcomes for patients with PTSD, yet families are infrequently integrated into evidence-based psychotherapies (EBPs). The investigators' goals are highly consistent with RR&D's mission to promote research that leverages family support as a pathway to reintegration and optimizes meaningful recovery and functioning.
Objectives. The investigators will complete stages 1A and 1B of the Stage Model of Treatment Development. Specifically, the investigators will: (1) Expand the treatment outline using content experts and feedback from key stakeholders (Veterans, intimate partners, providers, and VA mental health leadership). (2) Conduct a pilot open trial to assess (a) the acceptability of treatment components, structure, and materials, (b) the feasibility of the intervention (retention and intervention fidelity), and (c) the study approach (screening, recruitment, and assessment process). (3) Explore the preliminary effects of the intervention on select outcomes including overall functioning, mental health functioning, social functioning, family functioning, and potential mechanisms (social control, subjective norms, and the degree to which Veterans rely on their partners for support).
Methods: To accomplish Aim 1, the investigators will expand the outline for the intervention into an initial treatment manual through meetings with content experts and stakeholder feedback. Next, the investigators will develop fidelity checklists and revise the treatment manual through conducting the intervention with 2-3 couples. To accomplish Aims 2 and 3, the investigators will evaluate the intervention in a non-randomized, open trial with 10 Veterans diagnosed with PTSD and their intimate partners. Veterans will complete baseline and posttreatment structured diagnostic interviews. Both members of the couple will complete baseline surveys, posttreatment surveys, and posttreatment qualitative exit interviews. Using data obtained from the open trial, the investigators will assess the intervention's acceptability, feasibility, mechanisms, and outcomes. Upon completion of this proposal, the investigators will be well positioned to apply for Merit funding for a randomized clinical trial (Stage 2 of the Stage Model of Treatment Development) of this innovative, exposure based, couple therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Couples therapy, Psychotherapy, Veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loved one assisted treatment
Arm Type
Experimental
Arm Description
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Intervention Type
Behavioral
Intervention Name(s)
Loved one assisted treatment
Intervention Description
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale for DSM-5 to assess changes in PTSD symptoms. Scores range from 0 to 80, with higher scores indicating worse outcomes
Description
Structured clinical interview assessing symptoms of PTSD
Time Frame
Up to 26 weeks post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in VHA care
Clinically significant PTSD symptoms
Have a LO (loved one/intimate partner) with whom they have been in a romantic relationship with for 6 months
Will allow a LO to participate
Willing to be seen via telehealth when in-person treatment options aren't available.
Exclusion Criteria:
Actively suicidal/homicidal with intent and/or plan
Episode of mania/ psychosis in past 3 months
Severe substance use problem in past 3 months
Moderate relationship violence
Veteran has underlying medical condition or a planned medical procedure likely to impair ability to engage in treatment.
LO screens positive for PTSD
Veteran and/or LO fails to complete baseline survey
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A. Meis, PhD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
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