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

Not Applicable

Completed

• Conditions: PostTraumatic Stress Disorder
• Interventions: Other: Clinician supported smartphone application intervention

• Registration Number: NCT02956902
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2016-12
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Clinician supported smartphone application intervention	Clinician-supported smartphone application intervention

Primary Outcome Measures

Name	Time	Method
Change in PTSD symptom severity	8 weeks	Change in PTSD checklist (PCL-5) score

Secondary Outcome Measures

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