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

Study Overview
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Brief Summary
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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.

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

Conditions
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PostTraumatic Stress Disorder

Intervention / Treatment
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* Other: Clinician supported smartphone application intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting list control<br> | |
| Experimental: Intervention<br>Clinician-supported smartphone application intervention | Other: Clinician supported smartphone application intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptom severity | Change in PTSD checklist (PCL-5) score | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant change in PTSD symptom severity | Proportion of participants with a PCL-5 score less than 31 | 8 weeks | 
| Change in Depression Severity | Change in patient health questionnaire 9 (PHQ-9) score | 8 week | 
| Average App Use per Week (Intervention group only) | 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. | 8 weeks | 
| Goal Achievement (Intervention group only) | 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 | 8 weeks | 
| Clinician Fidelity to Protocol | 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. | 8 weeks |