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

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.

Study Overview

• Status: Completed
• Conditions: PostTraumatic Stress Disorder
• Intervention / Treatment: Other: Clinician supported smartphone application intervention

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list control
Experimental: Intervention; Clinician-supported smartphone application intervention	Other: Clinician supported smartphone application intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ontario Shores Centre for Mental Health Sciences
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 16-107IF