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Facilitating Transition to Recommended PTSD Treatment

Primary Purpose

PTSD

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment As Usual
New Health Services Intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PTSD focused on measuring PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TAU

New Health Services Intervention

Arm Description

Treatment As Usual with a VA mental health treatment coordinator

Novel health services intervention with a VA mental health treatment coordinator

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)
Patient self-report or documentation in the electronic health record that a patient has discontinued all mental health treatment without provider concurrence.
Limited Efficacy Testing (PTSD Symptom Severity)
Self-Reported PTSD Symptom Severity as assessed by the PTSD Checklist for DSM-5.

Full Information

First Posted
December 2, 2021
Last Updated
June 13, 2023
Sponsor
VA Office of Research and Development
Collaborators
White River Junction Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05165940
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
White River Junction Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive care coordination as usual (i.e., TAU) through the VA or an experimental care coordination intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment As Usual with a VA mental health treatment coordinator
Arm Title
New Health Services Intervention
Arm Type
Experimental
Arm Description
Novel health services intervention with a VA mental health treatment coordinator
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
Care Coordination Treatment as usual with a VA mental health treatment coordinator
Intervention Type
Behavioral
Intervention Name(s)
New Health Services Intervention
Intervention Description
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 Outcome Measure Information:
Title
Initiation of Recommended PTSD Treatment
Description
Patient self-report or documentation in the electronic health record of initiating either cognitive processing therapy (CPT) or prolonged exposure therapy (PE).
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)
Description
Patient self-report or documentation in the electronic health record that a patient has discontinued all mental health treatment without provider concurrence.
Time Frame
Through study completion, an average of 1 year
Title
Limited Efficacy Testing (PTSD Symptom Severity)
Description
Self-Reported PTSD Symptom Severity as assessed by the PTSD Checklist for DSM-5.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Holder, PhD
Phone
(415) 221-4810
Ext
23084
Email
nicholas.holder@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Holder, PhD
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121-1563
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Holder, PhD
Phone
415-221-4810
Ext
23084
Email
nicholas.holder@va.gov
First Name & Middle Initial & Last Name & Degree
Nicholas Holder, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Facilitating Transition to Recommended PTSD Treatment

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