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
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|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Clinician-Supported PTSD Coach Behavioral: Self-Managed PTSD Coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach: A Pilot Feasibility Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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.
Behavioral: Clinician-Supported PTSD Coach
Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
Active Comparator: Self-Managed PTSD Coach
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Behavioral: Self-Managed PTSD Coach
One 10 minute session explaining how to use the PTSD Coach mobile app.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Enrolled in primary care at the Syracuse VAMC,
- Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400710
|United States, New York|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Kyle Possemato, Ph.D.||Syracuse VAMC|
|Responsible Party:||Kyle Possemato, Clinical Research Psychologist, Syracuse VA Medical Center|
|Other Study ID Numbers:||
|First Posted:||March 27, 2015 Key Record Dates|
|Results First Posted:||February 3, 2016|
|Last Update Posted:||February 3, 2016|
|Last Verified:||January 2016|
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders