NCT02956902

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

November 3, 2016

Last Update Submit

April 14, 2023

Conditions

PostTraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD symptom severity

    Change in PTSD checklist (PCL-5) score

    8 weeks

Secondary Outcomes (5)

  • Clinically significant change in PTSD symptom severity

    8 weeks

  • Change in Depression Severity

    8 week

  • Average App Use per Week (Intervention group only)

    8 weeks

  • Goal Achievement (Intervention group only)

    8 weeks

  • Clinician Fidelity to Protocol

    8 weeks

Study Arms (2)

Waiting list control

NO INTERVENTION

Intervention

EXPERIMENTAL

Clinician-supported smartphone application intervention

Other: Clinician supported smartphone application intervention

Interventions

Clinician supported smartphone application interventionOTHER
Intervention

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 7, 2016

Study Start

December 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 18, 2023

Record last verified: 2023-04