Back to resultsA Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
Primary Purpose
PostTraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinician supported smartphone application intervention
Sponsored by
About this trial
This is an interventional treatment trial for PostTraumatic Stress Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Waiting list control
Intervention
Arm Description
Clinician-supported smartphone application intervention
Outcomes
Primary Outcome Measures
Change in PTSD symptom severity
Change in PTSD checklist (PCL-5) score
Secondary Outcome Measures
Clinically significant change in PTSD symptom severity
Proportion of participants with a PCL-5 score less than 31
Change in Depression Severity
Change in patient health questionnaire 9 (PHQ-9) score
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.
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
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.
Full Information
NCT ID
NCT02956902
First Posted
November 3, 2016
Last Updated
April 14, 2023
Sponsor
Ontario Shores Centre for Mental Health Sciences
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT02956902
Brief Title
A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
Official Title
A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Shores Centre for Mental Health Sciences
Collaborators
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PostTraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Waiting list control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clinician-supported smartphone application intervention
Intervention Type
Other
Intervention Name(s)
Clinician supported smartphone application intervention
Primary Outcome Measure Information:
Title
Change in PTSD symptom severity
Description
Change in PTSD checklist (PCL-5) score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinically significant change in PTSD symptom severity
Description
Proportion of participants with a PCL-5 score less than 31
Time Frame
8 weeks
Title
Change in Depression Severity
Description
Change in patient health questionnaire 9 (PHQ-9) score
Time Frame
8 week
Title
Average App Use per Week (Intervention group only)
Description
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.
Time Frame
8 weeks
Title
Goal Achievement (Intervention group only)
Description
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
Time Frame
8 weeks
Title
Clinician Fidelity to Protocol
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
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