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OpenTrials
Completed

NCT Number: NCT02400710

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

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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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

Syracuse VMAC

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC)
  • Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale
  • Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care
  • 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
  • Intent to begin PTSD treatment in specialty care

Treatment and study plan

Clinician-Supported PTSD Coach

Behavioral

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

Self-Managed PTSD Coach

Behavioral

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

Primary outcomes

  1. PTSD Checklist-Specific

    Time frame: 8 weeks

    Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.

Secondary outcomes

  1. Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record

    Time frame: 16 weeks

    Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.

Sponsors and collaborators

Lead sponsor

Syracuse VA Medical Center

Fed

Registry information

Official study title

Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach: A Pilot Feasibility Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 27, 2015
Registry last updated
Feb 3, 2016

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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