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

NCT ID: NCT04094922

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2021-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Free access to the Swedish PTSD Coach smartphone app for three months.

Group Type EXPERIMENTAL

Swedish PTSD Coach smartphone app

Intervention Type BEHAVIORAL

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.

Waitlist

Delayed access to the Swedish PTSD Coach smartphone app. Access is given after post-intervention data collection at three months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Swedish 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Filip K Arnberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Centre for Disaster Psychiatry, Department of Neuroscience, Uppsala University

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29805783 (View on PubMed)

Siverskog J, Andersson J, Hensler I, Gronqvist E, Arnberg FK. Cost-Effectiveness of App-Guided Self-Management for Posttraumatic Stress: Trial-Based Economic Evaluation. J Med Internet Res. 2025 Sep 18;27:e69426. doi: 10.2196/69426.

Reference Type DERIVED
PMID: 40966669 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35353052 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UU_neuro_kckp_PTSDcoach

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.