PostTraumatic Stress DisorderNCT02956902
A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
A study testing Clinician supported smartphone application intervention in people with PostTraumatic Stress Disorder, run by Ontario Shores Centre for Mental Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- PostTraumatic Stress Disorder
- What is being tested?
- Clinician supported smartphone application intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- active suicidal ideation
About this study
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.
- Conditions
- PostTraumatic Stress Disorder
- Being tested
- Clinician supported smartphone application intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician supported smartphone application interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Waiting list control | No intervention | Not described |
| Intervention | Experimental | Clinician-supported smartphone application intervention Receives: Other: Clinician supported smartphone application intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptom severity
Change in PTSD checklist (PCL-5) score
Measured: 8 weeks
Secondary outcomes (5)
Clinically significant change in PTSD symptom severity
Proportion of participants with a PCL-5 score less than 31
Measured: 8 weeks
Change in Depression Severity
Change in patient health questionnaire 9 (PHQ-9) score
Measured: 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.
Measured: 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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostTraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Shores Centre for Mental Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956902
- Sponsor's protocol ID
- 16-107IF
- Status last verified
- Apr 2023
- First submitted
- 3 Nov 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02956902
- Acronym / sponsor ID
- 16-107IF
- Conditions
- PostTraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ontario Shores Centre for Mental Health SciencesUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list control | No intervention | – |
| Intervention | Experimental | Other: Clinician supported smartphone application interventionClinician-supported smartphone application intervention |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- active suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician supported smartphone application intervention | Other | Intervention |
Primary outcome
Change in PTSD symptom severity
Time frame: 8 weeks
Change in PTSD checklist (PCL-5) score
5 secondary outcomes
Clinically significant change in PTSD symptom severity
Time frame: 8 weeks
Change in Depression Severity
Time frame: 8 week
Average App Use per Week (Intervention group only)
Time frame: 8 weeks
Goal Achievement (Intervention group only)
Time frame: 8 weeks
Clinician Fidelity to Protocol
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician supported smartphone application intervention in people with PostTraumatic Stress Disorder, run by Ontario Shores Centre for Mental Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptom severity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.