Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Supported Prolonged Exposure
Standard Prolonged Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, family therapy, patient adherence, Prolonged Exposure Therapy
Eligibility Criteria
Inclusion Criteria:
- Male or female veterans at least 18 years old. Recruitment is limited to Veterans enrolled in VHA care.
- 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).
- Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week
- Willing to allow this person to participate in the study.
- Provides informed consent.
- Speaks and reads English.
Exclusion Criteria:
- Current suicidal or homicidal ideation with intent and/or plan.
- Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.
- 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.
- 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).
- Support person screens positive for PTSD on a self-report instrument (PCL).
- Having an ongoing medical condition that would interfere with ability to attend weekly treatment sessions.
- Having any planned upcoming major medical procedures over the next several months that would interfere with ability to attend weekly treatment sessions.
- Veteran and/or SP fails to complete baseline survey
- Episode of mania/psychosis in past 3 months
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 2
Arm Type
Experimental
Active Comparator
Arm Label
Family Supported Prolonged Exposure
Standard Prolonged Exposure
Arm Description
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.
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Outcomes
Primary Outcome Measures
session attendance
Number of treatment sessions attended by the participant
Secondary Outcome Measures
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Full Information
NCT ID
NCT03256227
First Posted
August 9, 2017
Last Updated
July 18, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03256227
Brief Title
Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
Official Title
Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (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
Yes
5. Study Description
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.
Detailed Description
Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD, through increasing family support for treatment. Improving retention rates in evidence-based PTSD treatment will positively impact Veterans' health and well-being, lower the cost of treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach could help resolve national calls for routine inclusion of family involvement in PTSD treatment. Once demonstrated for PTSD, these strategies could be utilized for other conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better routine and evidence-based involvement of families in care.
Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to these treatments (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. Engaging families in Veterans' treatment may provide a powerful method for promoting EBP adherence. The investigators data indicate that 70% of Veterans express some interest in involving their family in their care for PTSD; yet, only 17% of providers have had any contact with Veterans' families. The objective of the proposed study is to evaluate the effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This research agenda directly addresses two VA HSR&D priorities:
innovative mental health care;
improving the quality of life for Veterans and their caregivers. The work aligns with the VHA Blueprint for Excellence and Strategic Plan through meeting the unique needs of military-service disabled Veterans, providing a novel treatment approach, and emphasizing patient- and family-centered care.
Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in care.
H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report greater homework compliance (H1b) than Veterans randomized to standard PE delivered in routine care.
Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in care.
H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and comorbid problems (depression, quality of life, relationship functioning) from baseline to posttreatment.
Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory Aim: To identify mechanisms underlying adherence differences between treatment conditions.
The investigators will explore if adherence differences are mediated by changes on key social influence variables (family perceptions of treatment credibility, family support for PE, and family symptom accommodation).
Methods. The investigators are proposing a practical randomized controlled trial to compare Veteran adherence, and to PE with and without family attendance at PE's educational sessions, with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators will use a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in PE within VA. Participants will include Veterans with clinically significant symptoms of PTSD across three sites, plus a family member or friend of the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim 2 outcomes include PTSD symptom severity, depression, quality of life, and relationship functioning, measured monthly over the course of treatment. Key social influences (Exploratory Aim) will be assessed through brief weekly self-reports.
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, family therapy, patient adherence, Prolonged Exposure Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Assessors are blinded to treatment condition
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Supported Prolonged Exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Prolonged Exposure
Arm Type
Active Comparator
Arm Description
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Intervention Type
Behavioral
Intervention Name(s)
Family Supported Prolonged Exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Prolonged Exposure
Intervention Description
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Primary Outcome Measure Information:
Title
session attendance
Description
Number of treatment sessions attended by the participant
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female veterans at least 18 years old. Recruitment is limited to Veterans enrolled in VHA care.
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).
Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week
Willing to allow this person to participate in the study.
Provides informed consent.
Speaks and reads English.
Exclusion Criteria:
Current suicidal or homicidal ideation with intent and/or plan.
Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.
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.
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).
Support person screens positive for PTSD on a self-report instrument (PCL).
Having an ongoing medical condition that would interfere with ability to attend weekly treatment sessions.
Having any planned upcoming major medical procedures over the next several months that would interfere with ability to attend weekly treatment sessions.
Veteran and/or SP fails to complete baseline survey
Episode of mania/psychosis in past 3 months
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
Citations:
PubMed Identifier
35354481
Citation
Meis LA, Glynn SM, Spoont MR, Kehle-Forbes SM, Nelson D, Isenhart CE, Eftekhari A, Ackland PE, Linden EB, Orazem RJ, Cutting A, Hagel Campbell EM, Astin MC, Porter KE, Smith E, Chuick CD, Lamp KE, Vuper TC, Oakley TA, Khan LB, Keckeisen SK, Polusny MA. Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement. Trials. 2022 Mar 30;23(1):243. doi: 10.1186/s13063-022-06183-2.
Results Reference
result
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Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
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