Posttraumatic StressNCT04094922
PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample
A study testing Swedish PTSD Coach smartphone app in people with Posttraumatic Stress, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress
- What is being tested?
- Swedish PTSD Coach smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSweden
- Study dates
- 8 May 2019to 7 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
National Centre for Disaster Psychiatry, Department of Neuroscience, Uppsala University
Uppsala, 75185
About this study
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.
Read the 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.
- Conditions
- Posttraumatic Stress
- Being tested
- Swedish PTSD Coach smartphone app
- Keywords
- Posttraumatic Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish PTSD Coach smartphone appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Free access to the Swedish PTSD Coach smartphone app for three months. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire for posttraumatic stress
Measured: 3 months (post)
Secondary outcomes (14)
PTSD Checklist for DSM-5
Self-report questionnaire for posttraumatic stress
Measured: 6 months (3 months after intervention end)
PTSD Checklist for DSM-5
Self-report questionnaire for posttraumatic stress
Measured: 9 months (6 months after intervention end)
Patient Health Questionnaire (PHQ-9)
Self-report questionnaire for depressive symptoms
Measured: 3 months (post intervention)
PHQ-9
Self-report questionnaire for depressive symptoms
Measured: 6 months (3 months after intervention end)
PHQ-9
Self-report questionnaire for depressive symptoms
Measured: 9 months (6 months after intervention end)
WHO Disability Assessment Schedule 2.0 (WHODAS)
Self-report questionnaire for functional disability, 12-item version
Measured: 3 months (post intervention)
WHODAS
Self-report questionnaire for functional disability, 12-item version
Measured: 6 months (3 months after intervention end)
WHODAS
Self-report questionnaire for functional disability, 12-item version
Measured: 9 months (6 months after intervention end)
Trimbos Questionnaire for Costs (TiC-P)
Self-report questionnaire for healthcare use and productivity loss
Measured: 3 months (post intervention)
TiC-P
Self-report questionnaire for healthcare use and productivity loss
Measured: 6 months (3 months after intervention end)
TiC-P
Self-report questionnaire for healthcare use and productivity loss
Measured: 9 months (6 months after intervention end)
Patient Health Questionnaire for physical symptoms (PHQ-15)
Self-report questionnaire for physical symptoms
Measured: 3 months (post intervention)
PHQ-15
Self-report questionnaire for physical symptoms
Measured: 6 months (3 months after intervention end)
PHQ-15
Self-report questionnaire for physical symptoms
Measured: 9 months (6 months after intervention end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start8 May 2019
- Primary completion5 Nov 2020
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic StressStudies 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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip K Arnberg, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094922
- Sponsor's protocol ID
- UU_neuro_kckp_PTSDcoach
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
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.
PubMed 29805783Siverskog 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.
PubMed 40966669Hensler 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.
PubMed 35353052
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample
- ClinicalTrials.gov ID
- NCT04094922
- Acronym / sponsor ID
- UU_neuro_kckp_PTSDcoach
- Conditions
- Posttraumatic Stress
- Keywords
- Posttraumatic Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Swedish PTSD Coach smartphone appFree access to the Swedish PTSD Coach smartphone app for three months. |
| Waitlist | No intervention | –Delayed access to the Swedish PTSD Coach smartphone app. Access is given after post-intervention data collection at three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Swedish PTSD Coach smartphone appSelf-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. | Behavioural | Intervention |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 3 months (post)
Self-report questionnaire for posttraumatic stress
14 secondary outcomes
PTSD Checklist for DSM-5
Time frame: 6 months (3 months after intervention end)
PTSD Checklist for DSM-5
Time frame: 9 months (6 months after intervention end)
Patient Health Questionnaire (PHQ-9)
Time frame: 3 months (post intervention)
PHQ-9
Time frame: 6 months (3 months after intervention end)
PHQ-9
Time frame: 9 months (6 months after intervention end)
WHO Disability Assessment Schedule 2.0 (WHODAS)
Time frame: 3 months (post intervention)
WHODAS
Time frame: 6 months (3 months after intervention end)
WHODAS
Time frame: 9 months (6 months after intervention end)
Trimbos Questionnaire for Costs (TiC-P)
Time frame: 3 months (post intervention)
TiC-P
Time frame: 6 months (3 months after intervention end)
TiC-P
Time frame: 9 months (6 months after intervention end)
Patient Health Questionnaire for physical symptoms (PHQ-15)
Time frame: 3 months (post intervention)
PHQ-15
Time frame: 6 months (3 months after intervention end)
PHQ-15
Time frame: 9 months (6 months after intervention end)
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 1 Oct 2021.
- Background: PubMed 29805783Cernvall 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.
- Derived from this study: PubMed 40966669Siverskog 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.
- Derived from this study: PubMed 35353052Hensler 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.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Filip K Arnberg, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish PTSD Coach smartphone app in people with Posttraumatic Stress, run by Uppsala University at 1 site in Sweden.
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 5 inclusion and 5 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 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
PTSD Checklist for DSM-5 (PCL-5) (time frame: 3 months (post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094922, which also lists 3 linked publications.
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 1 Oct 2021.