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Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

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ClinicalTrials.gov Identifier: NCT03256227
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to this treatment (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. This project will test the effectiveness of improving family support for PE as a tool to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite congressional legislation and national mandates within VA/DoD for family involvement in PTSD care, there remains no proven strategies for how to routinely include family in traditional individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a model of family engagement that can be translated to other problems faced by Veterans, including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain management, contributing to a broader evolution towards evidence-based, family-inclusive care.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Family Supported Prolonged Exposure Behavioral: Standard Prolonged Exposure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Assessors are blinded to treatment condition
Primary Purpose: Treatment
Official Title: Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 26, 2021

Arm Intervention/treatment
Experimental: Family Supported Prolonged Exposure
The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
Behavioral: Family Supported Prolonged Exposure
The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.

Active Comparator: Standard Prolonged Exposure
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Behavioral: Standard Prolonged Exposure
Standard Prolonged Exposure for PTSD as delivered in routine VA care.




Primary Outcome Measures :
  1. session attendance [ Time Frame: 16 weeks ]
    Number of treatment sessions attended by the participant


Secondary Outcome Measures :
  1. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 16 weeks ]
    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 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:

  1. Male or female veterans at least 18 years old. Recruitment is limited to Veterans enrolled in VHA care.
  2. Participant meets DSM-5 diagnostic criteria for PTSD or subthreshold PTSD. Consistent with recommendations, subthreshold PTSD will be defined as endorsement of criteria A (trauma), F (duration), and G (impairment), with at least one symptom from each of the remaining diagnostic criteria (Brancu et al., 2016).
  3. Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week
  4. Willing to allow this person to participate in the study.
  5. Provides informed consent.
  6. Speaks and reads English.

Exclusion Criteria:

  1. Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
  2. Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.
  3. Meets DSM-5 diagnostic criteria for a severe substance use disorder in the past 3 months. Of note, subjects can be abusing or dependent upon nicotine or marijuana and still be included in the study.
  4. Moderate relationship violence between the identified support person and the Veteran, defined as one or more episodes of severe violence in the past year (e.g., punched, kicked, or beat up).
  5. Support person screens positive for PTSD on a self-report instrument (PCL).
  6. Having an ongoing medical condition that would interfere with ability to attend weekly treatment sessions.
  7. Having any planned upcoming major medical procedures over the next several months that would interfere with ability to attend weekly treatment sessions.

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): NCT03256227


Contacts
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Contact: Erin B Linden, MPH (612) 725-5868 Erin.Linden@va.gov

Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Jillian Berfield, BS    404-321-6111    Jillian.Berfield@va.gov   
Sub-Investigator: Millie C. Astin, PhD         
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Katherine E Porter, PhD    734-845-5335    katherine.porter2@va.gov   
Sub-Investigator: Erin R Smith, PhD         
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Jill E Mahal-Lichty    612-467-1979    jill.mahal-lichty@va.gov   
Principal Investigator: Laura A. Meis, PhD         
Sub-Investigator: Melissa A. Polusny, PhD         
Sub-Investigator: Michele R. Spoont, PhD         
Sub-Investigator: Princess E. Ackland, PhD MSPH         
Sub-Investigator: Shannon M. Kehle-Forbes, 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: NCT03256227     History of Changes
Other Study ID Numbers: IIR 15-322
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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
family therapy
patient adherence
Prolonged Exposure Therapy

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders