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

NCT02400710 | Completed Results

• 1 other identifier: 00615
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  16 weeks

Study Arms (2)

Clinician-Supported PTSD Coach

EXPERIMENTAL

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.

Behavioral: Clinician-Supported PTSD Coach

Self-Managed PTSD Coach

ACTIVE COMPARATOR

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

Behavioral: Self-Managed PTSD Coach

Interventions

Clinician-Supported PTSD Coach BEHAVIORAL

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

Clinician-Supported PTSD Coach

Self-Managed PTSD Coach BEHAVIORAL

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

Self-Managed PTSD Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syracuse VA Medical Center: lead

Study Sites (1)

Syracuse VMAC

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Kyle Possemato, Ph.D.
• Organization: Center for Integrated Healthcare, Syracuse Veterans Affairs Medical Center

kyle.possmato@va.gov

315-425-4400

Study Officials

• Kyle Possemato, Ph.D.

  Syracuse VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Psychologist

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 27, 2015
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2016-01

Locations

US (1)