Menu
Not yet recruiting NCT05165940

Facilitating Transition to Recommended PTSD Treatment

No phase Interventional PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment As Usual, New Health Services Intervention.
Who it may be relevant to
Registry conditions: PTSD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)

Overview

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.

Interventions

  • Behavioral Treatment As Usual
    Care Coordination Treatment as usual with a VA mental health treatment coordinator
  • Behavioral New Health Services Intervention
    The experimental care coordination intervention begins with a 60-minute in-person session and continues with regular, brief contacts between the Veteran and clinician. During the first session, the clinician and Veteran will (1) discuss the Veteran's beliefs about their presenting problem; (2) collaboratively identify SMART goals; (3) discuss treatment options; (4) use shared decision-making to match treatment to SMART goals; (5) develop criteria to evaluate treatment progress; and (6) manage tr

Primary outcome measures

  • Initiation of Recommended PTSD Treatment [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence) [Time frame: Through study completion, an average of 1 year]
  • Limited Efficacy Testing (PTSD Symptom Severity) [Time frame: Through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • San Francisco VA Medical Center, San Francisco, CA — San Francisco

Identifiers

NCT: NCT05165940 · CDX 22-002 · 1IK2HX003339-01A2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗