Posttraumatic Stress Disorder
Conditions
Keywords
Posttraumatic Stress Disorder, family therapy, patient adherence, Prolonged Exposure Therapy
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.
Interventions
BEHAVIORALStandard Prolonged Exposure
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
BEHAVIORALFamily 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors are blinded to treatment condition
Intervention model description
effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 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. 8. Veteran and/or SP fails to complete baseline survey 9. Episode of mania/psychosis in past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Session Attendance | 16 weeks | Number of treatment sessions attended by the participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | 16 weeks | The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 64 |
| Standard Prolonged Exposure Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care. | 64 |
| Total | 128 |
Baseline characteristics
| Characteristic | Family Supported Prolonged Exposure | Standard Prolonged Exposure | Total |
|---|---|---|---|
| Age, Continuous | 49.30 years STANDARD_DEVIATION 14.7 | 51.23 years STANDARD_DEVIATION 15.04 | 50.38 years STANDARD_DEVIATION 14.81 |
| Lives with Significant Other | 48 Participants | 40 Participants | 88 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 14 Participants | 14 Participants | 28 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiracial | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 41 Participants | 36 Participants | 77 Participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 50 Participants | 53 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 17 / 64 | 20 / 64 |
| serious Total, serious adverse events | 2 / 64 | 2 / 64 |
Outcome results
Primary
Session Attendance
Number of treatment sessions attended by the participant
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Supported Prolonged Exposure | Session Attendance | 6.77 sessions | Standard Deviation 3.99 |
| Standard Prolonged Exposure | Session Attendance | 5.56 sessions | Standard Deviation 4.16 |
Secondary
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. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels.
Time frame: 16 weeks
Population: Veterans who completed PCL5 measure at post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Supported Prolonged Exposure | PTSD Checklist for DSM-5 (PCL-5) | 51.56 score on a scale | Standard Deviation 12.6 |
| Standard Prolonged Exposure | PTSD Checklist for DSM-5 (PCL-5) | 53.79 score on a scale | Standard Deviation 12.54 |