Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs

NCT ID: NCT03533608

Last Updated: 2023-07-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-03-15

Brief Summary

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Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.

Detailed Description

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Fifty Veterans who are currently receiving treatment in the PTSD RRTP at a Midwest VA will be recruited to participate in a Group PE protocol. Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms will be measured via the PCL-5. The goal of this pilot study will be to determine whether or not it will be feasible to conduct a full-scale trial of Group PE in the current setting by testing the process, resources, management, and scientific basis of the planned trial. As such, the proposed study will primarily assess feasibility outcomes and not efficacy outcomes. The investigators will assess number of participants screened, number meeting inclusion criteria, adherence of participants to the proposed treatment (measured via number of sessions attended), standard deviation of the outcome measure (PCL-5), response rates to questionnaires, and loss to follow-up. The investigators will also measure clinicians' adherence to protocol and acceptability of the treatment to patients.

Conditions

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PTSD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group PE

Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Group Type EXPERIMENTAL

Group PE

Intervention Type BEHAVIORAL

Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Interventions

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Group PE

Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* Inclusion criteria are current engagement in treatment at the Battle Creek VA PTSD Residential Rehabilitation Treatment Program.

Exclusion Criteria:

* Exclusion criteria are severe cognitive impairment that in the judgment of the PI or the patient's clinical providers make it unlikely that the patient can adhere to the study protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Kaufman Sripada, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

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VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CDA 15-251

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDX 18-002

Identifier Type: -

Identifier Source: org_study_id

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