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

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ClinicalTrials.gov Identifier: NCT02400710
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Kyle Possemato, Syracuse VA Medical Center

Tracking Information
First Submitted Date  ICMJE March 16, 2015
First Posted Date  ICMJE March 27, 2015
Results First Submitted Date  ICMJE November 19, 2015
Results First Posted Date  ICMJE February 3, 2016
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
PTSD Symptoms as measured by the PTSD Checklist [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT02400710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach
Official Title  ICMJE Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach: A Pilot Feasibility Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Behavioral: Clinician-Supported PTSD Coach
    Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
  • Behavioral: Self-Managed PTSD Coach
    One 10 minute session explaining how to use the PTSD Coach mobile app.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Clinician-Supported PTSD Coach
  • Active Comparator: Self-Managed PTSD Coach
    One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
    Intervention: Behavioral: Self-Managed PTSD Coach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2015)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400710
Other Study ID Numbers  ICMJE 00615
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyle Possemato, Syracuse VA Medical Center
Study Sponsor  ICMJE Syracuse VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle Possemato, Ph.D. Syracuse VAMC
PRS Account Syracuse VA Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP