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

NCT04094922 | Completed

• 1 other identifier: UU_neuro_kckp_PTSDcoach
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress

Keywords

Posttraumatic Stress

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL-5)

  Self-report questionnaire for posttraumatic stress

  3 months (post)

Secondary Outcomes (14)

• PTSD Checklist for DSM-5

  6 months (3 months after intervention end)

• PTSD Checklist for DSM-5

  9 months (6 months after intervention end)

• Patient Health Questionnaire (PHQ-9)

  3 months (post intervention)

• PHQ-9

  6 months (3 months after intervention end)

• PHQ-9

  9 months (6 months after intervention end)

Other Outcomes (2)

• PTSD Coach Survey

  3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)

• Negative Effects Questionnaire (NEQ)

  3 months (post intervention for intervention group); 6 months (post intervention for waitlist group)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Swedish PTSD Coach smartphone app

Waitlist

NO INTERVENTION

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

Interventions

Swedish PTSD Coach smartphone app 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

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

Uppsala, 75185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 29805783 BACKGROUND

• 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.

  PMID: 40966669 DERIVED

• 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.

  PMID: 35353052 DERIVED

Study Officials

• Filip K Arnberg, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: May 8, 2019
• Primary Completion: November 5, 2020
• Study Completion: April 7, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)