Facilitating Transition to Recommended PTSD Treatment

NCT05165940 | Not Yet Recruiting

• 2 other identifiers: CDX 22-0021IK2HX003339-01A2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• Initiation of Recommended PTSD Treatment

  Patient self-report or documentation in the electronic health record of initiating either cognitive processing therapy (CPT) or prolonged exposure therapy (PE).

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)

  Through study completion, an average of 1 year

• Limited Efficacy Testing (PTSD Symptom Severity)

  Through study completion, an average of 1 year

Study Arms (2)

TAU

ACTIVE COMPARATOR

Treatment As Usual with a VA mental health treatment coordinator

Behavioral: Treatment As Usual

New Health Services Intervention

EXPERIMENTAL

Novel health services intervention with a VA mental health treatment coordinator

Behavioral: New Health Services Intervention

Interventions

Treatment As Usual BEHAVIORAL

Care Coordination Treatment as usual with a VA mental health treatment coordinator

TAU

New Health Services Intervention BEHAVIORAL

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 treatment expectations. During follow-up sessions, the clinician and Veteran will reflect on treatment progress, make appropriate updates to SMART goals, and re-evaluate barriers to CPT or PE.

New Health Services Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• White River Junction Veterans Affairs Medical Center: collaborator

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nicholas Holder, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Holder, PhD

CONTACT

(415) 221-4810; nicholas.holder@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive care coordination as usual (i.e., TAU) through the VA or an experimental care coordination intervention.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 21, 2021
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): May 3, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)