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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02956902
Enrollment
67
Registered
2016-11-07
Start date
2016-12-31
Completion date
2017-04-30
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PostTraumatic Stress Disorder

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.

Interventions

OTHERClinician supported smartphone application intervention

Sponsors

US Department of Veterans Affairs
CollaboratorFED
Ontario Shores Centre for Mental Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in PTSD symptom severity8 weeksChange in PTSD checklist (PCL-5) score

Secondary

MeasureTime frameDescription
Clinically significant change in PTSD symptom severity8 weeksProportion of participants with a PCL-5 score less than 31
Change in Depression Severity8 weekChange in patient health questionnaire 9 (PHQ-9) score
Average App Use per Week (Intervention group only)8 weeksSelf-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.
Goal Achievement (Intervention group only)8 weeksAt 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
Clinician Fidelity to Protocol8 weeksA 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026