Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:January 15, 2018
End Date:February 26, 2021
Contact:Erin B Linden, MPH
Email:Erin.Linden@va.gov
Phone:(612) 725-5868

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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.

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.

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,
picked, or beat up).

5. Support person screens positive for PTSD on a self-report instrument.

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.
We found this trial at
3
sites
Decatur, Georgia 30033
Phone: 404-321-6111
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Decatur, GA
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Ann Arbor, Michigan 48113
Phone: 734-845-5335
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Ann Arbor, MI
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Minneapolis, Minnesota 55417
Principal Investigator: Laura A. Meis, PhD
Phone: 612-467-1979
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Minneapolis, MN
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