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

April 14, 2023 updated by: Ontario Shores Centre for Mental Health Sciences
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Proportion of participants with a PCL-5 score less than 31
8 weeks
Change in Depression Severity
Time Frame: 8 week
Change in patient health questionnaire 9 (PHQ-9) score
8 week
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.
8 weeks
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
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Shores Centre for Mental Health Sciences

Collaborators

US Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 16-107IF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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