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

Ontario Shores Centre for Mental Health Sciences67 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PostTraumatic Stress Disorder

Interventions

Clinician supported smartphone application interventionOTHER

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in PTSD symptom severity

Change in PTSD checklist (PCL-5) score

Time frame: 8 weeks

Secondary Outcomes

Clinically significant change in PTSD symptom severity

Proportion of participants with a PCL-5 score less than 31

Time frame: 8 weeks

Change in Depression Severity

Change in patient health questionnaire 9 (PHQ-9) score

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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