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Completed

NCT Number: NCT02956902

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinician supported smartphone application intervention

Other

Primary outcomes

  1. Change in PTSD symptom severity

    Time frame: 8 weeks

    Change in PTSD checklist (PCL-5) score

Secondary outcomes

  1. Clinically significant change in PTSD symptom severity

    Time frame: 8 weeks

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

  2. Change in Depression Severity

    Time frame: 8 week

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

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Ontario Shores Centre for Mental Health Sciences

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2016
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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