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NCT Number: NCT05165940

Facilitating Transition to Recommended PTSD Treatment

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location contact

Nicholas Holder, PhD

CONTACT

[email protected]

415-221-4810 ext. 23084

Nicholas Holder, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

Behavioral

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

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.

Primary outcomes

  1. Initiation of Recommended PTSD Treatment

    Time frame: Through study completion, an average of 1 year

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

Secondary outcomes

  1. Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)

    Time frame: Through study completion, an average of 1 year

    Patient self-report or documentation in the electronic health record that a patient has discontinued all mental health treatment without provider concurrence.

  2. Limited Efficacy Testing (PTSD Symptom Severity)

    Time frame: Through study completion, an average of 1 year

    Self-Reported PTSD Symptom Severity as assessed by the PTSD Checklist for DSM-5.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas Holder, PhD

CONTACT

[email protected]

(415) 221-4810 ext. 23084

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • White River Junction Veterans Affairs Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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