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A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02956902
Recruitment Status : Unknown
Verified November 2016 by Ontario Shores Centre for Mental Health Sciences.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2016
Last Update Posted : November 8, 2016
US Department of Veterans Affairs
Information provided by (Responsible Party):
Ontario Shores Centre for Mental Health Sciences

Brief Summary:
This study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than those who do not. Half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.

Condition or disease Intervention/treatment Phase
PostTraumatic Stress Disorder Other: Clinician supported smartphone application intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
Study Start Date : December 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Waiting list control
Experimental: Intervention
Clinician-supported smartphone application intervention
Other: Clinician supported smartphone application intervention

Primary Outcome Measures :
  1. Change in PTSD symptom severity [ Time Frame: 8 weeks ]
    Change in PTSD checklist (PCL-5) score

Secondary Outcome Measures :
  1. Clinically significant change in PTSD symptom severity [ Time Frame: 8 weeks ]
    Proportion of participants with a PCL-5 score less than 31

  2. Change in Depression Severity [ Time Frame: 8 week ]
    Change in patient health questionnaire 9 (PHQ-9) score

  3. Average App Use per Week (Intervention group only) [ Time Frame: 8 weeks ]
    Self-report app use will be collected by the clinician at each of sessions 2-4 by asking "on average, how many times did you use the app per day (or per week, if less than once per day). The clinician will also ask which of the four main functions were used and which symptom management tools were used most and were most helpful.

  4. Goal Achievement (Intervention group only) [ Time Frame: 8 weeks ]
    At each of sessions 1-3, the clinician will help the participant set goals, which will be documented. At each of sessions 2-4 the clinician will ask the participant to self-report goal achievement, which will be documented

  5. Clinician Fidelity to Protocol [ Time Frame: 8 weeks ]
    A fidelity checklist has been created for this protocol, which will be completed over the course of the intervention. The form will be updated upon completion of each clinician session.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • on the waiting list for the Ontario Shores traumatic stress clinic;
  • score ≥ 31 on the PCL-5
  • have access to a smartphone or tablet to which they are willing to download the app.

Exclusion Criteria:

  • active suicidal ideation
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Responsible Party: Ontario Shores Centre for Mental Health Sciences Identifier: NCT02956902    
Other Study ID Numbers: 16-107IF
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders