- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094922
PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample
Individuals who experience potentially traumatic events might develop long-lasting mental health problems. Limitations to health care resources, particularly in the context of mass disasters, indicate that self-help interventions could serve as important complementary offers to people in need.
The aim of this study is to evaluate whether the Swedish version of the Swedish version of the PTSD Coach self-help smartphone application can reduce levels of posttraumatic stress and related difficulties. The study is a randomized controlled trial in which participants' levels of posttraumatic stress and related difficulties after three months use of PTSD Coach will be compared to a waitlist condition. Additionally, in order to better understand the interplay between app use and health status, participants in both groups will receive text messages in which they are asked to respond to a small number of very brief questions about specific behaviors and current health status for three weeks during the intervention period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A majority of humans experience a potentially traumatic event during their lifetime, and many experience more than one. These events are of overwhelming emotional nature and have the capacity to evoke intensive distress. For many people, the distress dissipates either spontaneously or with the help from professional supports over the course of a couple of weeks. However, a substantial minority of people go on to develop significant levels of posttraumatic stress.
Chronic posttraumatic stress is often experienced together with clinical levels of other forms of psychopathology such as depression or anxiety disorders and the chronic condition can become debilitating over many years. There are effective interventions, however, they are as of yet difficult to access.
An uncontrolled pilot study of the Swedish PTSD Coach smartphone app indicated favorable outcomes and feasibility of the intervention (Cernvall, Sveen, Johannesson, & Arnberg, 2018). The app includes four modules: psychoeducation, rating and monitoring of distress, information about help and support, and strategies to cope with distress. The app is designed to be used with or without internet connection and uses little space on the smartphone.
This study will investigate whether the Swedish version of the PTSD Coach self-help smartphone application is beneficial for people who experience elevated levels of posttraumatic stress after a potentially traumatic event. The study is a randomized controlled trial with two conditions. In the intervention condition, participants are allowed free use of the PTSD Coach smartphone app. The control group is a waitlist condition. The intervention will take place during three months and is powered to detect a between-group effect size at the post-intervention assessment of d=0.5.
This study will also use an intensive longitudinal data collection method within the intervention period in order to better understand the interplay between app use and health status. Participants in both groups will receive text messages in which they are asked to respond to six very brief questions about specific behaviors and current health status for three weeks during the intervention period.
After the intervention period, participants across groups will be compared on a number of outcome variables related to posttraumatic stress, other mental health issues, daily function, and measures on healthcare consumption. The participants in the waitlist group will then be given access to the PTSD Coach app and both groups will be followed for two additional assessments after six and nine months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Uppsala, Sweden, 75185
- National Centre for Disaster Psychiatry, Department of Neuroscience, Uppsala university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
- Adequate Swedish language comprehension
- Experienced a potentially traumatic event according to DSM-5 PTSD Criterion A during the past 2 years
- At least mild forms of posttraumatic stress, i.e., PCL-5 total score ≥ 10
- Access to smartphone able to run PTSD Coach app
Exclusion Criteria:
- Positive screening for bipolar disorder, psychotic disorder, ongoing substance disorder, or severe suicidality according to Mini International Neuropsychiatric Interview version 7.0.0
- current or planned psychological treatment within next three months
- current use of medication that may influence psychological treatment
- change in medication in the past months or planned changes within next three months
- ongoing potential traumatic context (e.g., ongoing domestic violence)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Free access to the Swedish PTSD Coach smartphone app for three months.
|
Self-help smartphone app targeted towards posttraumatic stress that includes psychoeducation, rating/monitoring of distress, lists of support and treatment resources, and strategies for coping with distress.
|
No Intervention: Waitlist
Delayed access to the Swedish PTSD Coach smartphone app.
Access is given after post-intervention data collection at three months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: 3 months (post)
|
Self-report questionnaire for posttraumatic stress
|
3 months (post)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist for DSM-5
Time Frame: 6 months (3 months after intervention end)
|
Self-report questionnaire for posttraumatic stress
|
6 months (3 months after intervention end)
|
PTSD Checklist for DSM-5
Time Frame: 9 months (6 months after intervention end)
|
Self-report questionnaire for posttraumatic stress
|
9 months (6 months after intervention end)
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 3 months (post intervention)
|
Self-report questionnaire for depressive symptoms
|
3 months (post intervention)
|
PHQ-9
Time Frame: 6 months (3 months after intervention end)
|
Self-report questionnaire for depressive symptoms
|
6 months (3 months after intervention end)
|
PHQ-9
Time Frame: 9 months (6 months after intervention end)
|
Self-report questionnaire for depressive symptoms
|
9 months (6 months after intervention end)
|
WHO Disability Assessment Schedule 2.0 (WHODAS)
Time Frame: 3 months (post intervention)
|
Self-report questionnaire for functional disability, 12-item version
|
3 months (post intervention)
|
WHODAS
Time Frame: 6 months (3 months after intervention end)
|
Self-report questionnaire for functional disability, 12-item version
|
6 months (3 months after intervention end)
|
WHODAS
Time Frame: 9 months (6 months after intervention end)
|
Self-report questionnaire for functional disability, 12-item version
|
9 months (6 months after intervention end)
|
Trimbos Questionnaire for Costs (TiC-P)
Time Frame: 3 months (post intervention)
|
Self-report questionnaire for healthcare use and productivity loss
|
3 months (post intervention)
|
TiC-P
Time Frame: 6 months (3 months after intervention end)
|
Self-report questionnaire for healthcare use and productivity loss
|
6 months (3 months after intervention end)
|
TiC-P
Time Frame: 9 months (6 months after intervention end)
|
Self-report questionnaire for healthcare use and productivity loss
|
9 months (6 months after intervention end)
|
Patient Health Questionnaire for physical symptoms (PHQ-15)
Time Frame: 3 months (post intervention)
|
Self-report questionnaire for physical symptoms
|
3 months (post intervention)
|
PHQ-15
Time Frame: 6 months (3 months after intervention end)
|
Self-report questionnaire for physical symptoms
|
6 months (3 months after intervention end)
|
PHQ-15
Time Frame: 9 months (6 months after intervention end)
|
Self-report questionnaire for physical symptoms
|
9 months (6 months after intervention end)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Coach Survey
Time Frame: 3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)
|
Self-report questionnaire to assess user satisfaction and perceived helpfulness of the app
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3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)
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Negative Effects Questionnaire (NEQ)
Time Frame: 3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)
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Self-report questionnaire for negative effects related to the intervention
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3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Filip K Arnberg, PhD, Uppsala University
Publications and helpful links
General Publications
- Cernvall M, Sveen J, Bergh Johannesson K, Arnberg F. A pilot study of user satisfaction and perceived helpfulness of the Swedish version of the mobile app PTSD Coach. Eur J Psychotraumatol. 2018 May 17;9(Suppl 1):1472990. doi: 10.1080/20008198.2018.1472990. eCollection 2018.
- Hensler I, Sveen J, Cernvall M, Arnberg FK. Efficacy, Benefits, and Harms of a Self-management App in a Swedish Trauma-Exposed Community Sample (PTSD Coach): Randomized Controlled Trial. J Med Internet Res. 2022 Mar 30;24(3):e31419. doi: 10.2196/31419.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UU_neuro_kckp_PTSDcoach
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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