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Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention.
Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFI | Experimental | Family members in this arm receive the 2-session BFI intervention. |
|
| No BFI | No Intervention | Family members in this arm do not receive the BFI sessions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Family Intervention (BFI) | Behavioral | A 2-session psychoeducational and skills-based family intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Severity of PTSD symptoms. Minimum score is 0 (best possible, no symptoms) and maximum score is 80 (worst possible, highest symptoms). | Week 26 |
| Adequate treatment dose | Categorical evaluation of whether the participant received 8 or more on-protocol sessions of CPT or PE during their 26-week study participation period. Possible scores are 0 (meaning <8 sessions received; this is considered a poor outcome) or 1 (meaning 8 or more sessions received; this is considered a good outcome). | Week 26 |
| Treatment dropout | Categorical evaluation of whether the participant dropped out of treatment early. Possible scores are 0 (meaning participant did not drop out of treatment early; this is considered a good outcome) or 1 (meaning participant did drop out of treatment early; this is considered a poor outcome). | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Homework compliance | Compliance with assigned homework during treatment. Minimum score is 0 (worst possible), maximum score is 150 (best possible). | Week 26 |
| Quality of Life Inventory (QOLI) | Quality of life. Minimum score is -6 (worst possible), maximum score is 6 (best possible). |
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Inclusion Criteria:
Inclusion criteria for Veterans will include:
a current DSM-5 diagnosis of PTSD
Veteran status
willing to have a family member involved in the study
has recently begun or is currently initiating individual CPT or PE (completed no more than 3 sessions of the protocol at the time of the baseline assessment)
Inclusion criteria for family members will include:
Exclusion Criteria:
Exclusion criteria for Veterans will include:
Exclusion criteria for family members will include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Thompson-Hollands, PhD | Contact | (857) 364-2067 | Johanna.Thompson-Hollands@va.gov | |
| Cameron Busser, BA | Contact | (857) 364-4143 | cameron.busser@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Johanna Thompson-Hollands, PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Recruiting | Boston | Massachusetts | 02130-4817 | United States |
An anonymous dataset that meets VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distributions, a privacy officer at the primary site will certify that all datasets contain no PHI. The PI will create a de-identified dataset that will include all publication variables. To remove some PHI, loss of information may occur. The PI will replace any identifiable information with study-specific numbers. Data collected on age will be replaced by the PI with age categories to ensure data is in accordance with PHI requirements for people 85 years of age and older (if applicable).
An anonymous dataset that meets VA standards for disclosure to the public will be made available within 1 year of publication. The data will be made available until the data is destroyed according to the required timelines in the VA Record Control Schedule.
Individual requesting access to the data will be required to complete an adequate Data Use Agreement.
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Family members are randomly assigned to one of the following two groups: Brief Family Intervention (BFI) where they receive a 2-session intervention designed to help them better understand and support the Veteran's individual trauma-focused treatment, or no BFI where they do not receive the BFI sessions.
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Outcomes assessors are blind to the condition of the family member/Veteran
| Week 26 |
| Durham VA Medical Center, Durham, NC | Recruiting | Durham | North Carolina | 27705-3875 | United States |
|
| Cincinnati VA Medical Center, Cincinnati, OH | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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