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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400710
• Other study ID #: 00615
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: January 4, 2016
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Syracuse VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Clinician-Supported PTSD Coach
Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
• Self-Managed PTSD Coach
One 10 minute session explaining how to use the PTSD Coach mobile app.

Locations

Country	Name	City	State
United States	Syracuse VMAC	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Syracuse VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist-Specific	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.	8 weeks	No
Secondary	Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record	Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.	16 weeks	No