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Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241094
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Loved one assisted treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing
Estimated Study Start Date : November 2, 2020
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Loved one assisted treatment
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.
Behavioral: Loved one assisted treatment
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 Measures :
  1. 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 [ Time Frame: Up to 26 weeks post baseline ]
    Structured clinical interview assessing symptoms of PTSD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241094


Contacts
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Contact: Laura A Meis, PhD (612) 467-4516 laura.meis@va.gov

Locations
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United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Contact: Jill E Mahal-Lichty    612-467-1979    jill.mahal-lichty@va.gov   
Principal Investigator: Laura A. Meis, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Laura A. Meis, PhD Minneapolis VA Health Care System, Minneapolis, MN
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04241094    
Other Study ID Numbers: D3460-P
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Posttraumatic Stress Disorder
Couples therapy
Psychotherapy
Veterans
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders