Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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PTSD Coach is a mobile application (app) that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms. There is research evidence that self-management programs are often underutilized, but that clinician contact can increase patient involvement. The addition of clinician support may enhance the utilization and effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder interviews with primary care (PC) and mental health (MH) leadership staff to investigate barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase the uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2 the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1) investigate the feasibility of recruiting and retaining participants and delivering the SM and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS. The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes will be generated for the following outcomes: a) reductions in PTSD, depression, and general distress, and increases in health-related functioning, b) increases in knowledge about PTSD symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in initiation of tradition PTSD treatments.

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Detailed Description

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clinician-Supported PTSD Coach

Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.

Group Type EXPERIMENTAL

Clinician-Supported PTSD Coach

Intervention Type BEHAVIORAL

Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

Self-Managed PTSD Coach

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Group Type ACTIVE_COMPARATOR

Self-Managed PTSD Coach

Intervention Type BEHAVIORAL

One 10 minute session explaining how to use the PTSD Coach mobile app.

Interventions

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Clinician-Supported PTSD Coach

Brief primary care-based intervention provided by a mental health clinician who is located in primary care.

Intervention Type BEHAVIORAL

Self-Managed PTSD Coach

One 10 minute session explaining how to use the PTSD Coach mobile app.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Enrolled in primary care at the Syracuse VAMC,
2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40.

Exclusion Criteria

1. Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC)
2. Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale
3. Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care
4. A new psychotropic medication or a change in dose of a psychotropic medication for PTSD in the last two months that was received outside of VA primary care
5. Intent to begin PTSD treatment in specialty care

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes