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PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample

PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04094922
Enrollment
174
Registered
2019-09-19
Start date
2019-05-08
Completion date
2021-04-07
Last updated
2021-10-01

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

Conditions

Posttraumatic Stress

Keywords

Posttraumatic Stress

Brief summary

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.

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.

Interventions

BEHAVIORALSwedish PTSD Coach smartphone app

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.

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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)

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for DSM-5 (PCL-5)3 months (post)Self-report questionnaire for posttraumatic stress

Secondary

MeasureTime frameDescription
PTSD Checklist for DSM-56 months (3 months after intervention end)Self-report questionnaire for posttraumatic stress
Patient Health Questionnaire (PHQ-9)3 months (post intervention)Self-report questionnaire for depressive symptoms
PHQ-96 months (3 months after intervention end)Self-report questionnaire for depressive symptoms
WHO Disability Assessment Schedule 2.0 (WHODAS)3 months (post intervention)Self-report questionnaire for functional disability, 12-item version
WHODAS6 months (3 months after intervention end)Self-report questionnaire for functional disability, 12-item version
Patient Health Questionnaire for physical symptoms (PHQ-15)3 months (post intervention)Self-report questionnaire for physical symptoms
PHQ-156 months (3 months after intervention end)Self-report questionnaire for physical symptoms
Trimbos Questionnaire for Costs (TiC-P)3 months (post intervention)Self-report questionnaire for healthcare use and productivity loss
TiC-P6 months (3 months after intervention end)Self-report questionnaire for healthcare use and productivity loss

Other

MeasureTime frameDescription
PTSD Coach Survey3 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
Negative Effects Questionnaire (NEQ)3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)Self-report questionnaire for negative effects related to the intervention

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026