Clinical trial NCT05165940: Facilitating Transition to Recommended PTSD Treatment
Official title: Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD
Keywords: PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: White River Junction Veterans Affairs Medical Center
First posted: 2021-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive care coordination as usual (i.e., TAU) through the VA or an experimental care coordination intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.

Detailed description: Posttraumatic stress disorder (PTSD) is one of the most common mental health diagnoses among Veterans. Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated in the Veterans Health Administration (VHA) as recommended PTSD treatments. Despite these efforts, few post-9/11 Veterans diagnosed with PTSD initiate CPT or PE. In the small percentage of Veterans who receive these therapies, CPT and PE are rarely the first treatment a Veteran receives. A common treatment sequence identified in implementation research, begins with "stabilization treatment," combinations of psychosocial and medication treatments that prepare Veterans for CPT or PE. Despite consistently identifying stabilization treatment as a common VHA practice, little research has investigated this treatment sequence. A novel approach to solving existing limitations in PTSD treatment delivery involves developing an intervention that both acknowledges the ubiquitous presence and benefits of stabilization treatment, while facilitating timely transition from stabilization treatment to CPT or PE. This CDA-2 aims to improve delivery of PTSD services in the VHA. The proposed research aims are: (1) To qualitatively understand Veterans' and clinicians' perspectives on selecting stabilization treatments and how stabilization treatment serves as a barrier or facilitator of transition to CPT or PE; (2) To develop and conduct a randomized, pragmatic pilot trial of a brief, Veteran-centered intervention to support transition from stabilization treatment to CPT or PE; and (3) To identify sociodemographic disparities in treatment sequences and to determine how treatment sequences influence time to CPT or PE initiation across the VHA.

Eligibility criteria: Inclusion Criteria:

* Veteran
* Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center.

Exclusion Criteria:

* Inability to provide informed consent
* Cognitive impairment that precludes comprehension of study materials
* Active psychosis

Primary outcomes:
measure: Initiation of Recommended PTSD Treatment
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)
timeFrame: Through study completion, an average of 1 year
measure: Limited Efficacy Testing (PTSD Symptom Severity)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Nicholas Holder, PhD
role: PRINCIPAL_INVESTIGATOR
References: