Posttraumatic Stress DisorderNCT06193161
Prolonged Exposure for Swedish Immigrants
A study testing Therapist-supported internet delivered prolonged exposure in people with Posttraumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure (I-PE) in simple english to a waiting list condition for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Therapist-supported internet delivered prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Current primary diagnosis of PTSD, according to the diagnostic criteria based on Diagnostic and statistical manual of mental disorders, 5th edition (DSM-5; American Psychiatric Association, 2013)
- ≥ 18 years
- Able to read and write in English
- Immigrant residing in Sweden
- Able to provide digital informed consent
- Daily access to a computer or device with internet connection
Who cannot join
- PTSD is not the primary treatment concern
- Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention.
- Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olof Molander, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Solna
Maria Bragesjö, PhD, +46703399387, maria.bragesjo@ki.se
Olof Molander, PhD, olof.molander@ki.se
About this study
Official title: Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure (I-PE) in simple english to a waiting list condition for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD).
The main objectives are to establish feasibility and preliminary efficacy of I-PE for immigrants with PTSD in a single-blind, parallel-group superiority Randomized Controlled Trial (N=100) comparing I-PE with a waiting-list condition, starting with a nested pilot (N=30) to ensure feasible and acceptable recruitment and treatment strategies. Study participants will be randomly assigned to either eight weeks of I-PE or a waiting-list for the same amount of time on a 1:1 ratio without restriction. Feasibility and acceptability data will be reported including recruitment rate, sample demographics, data attrition, treatment adherence and a detailed dropout analysis. A preliminary investigation of the within-group effect size will also be conducted. Recruitment is designed to be broadly inclusive with minimal exclusion criteria.
Read the detailed description
There is an urgent need for dissemination of evidence-based treatments for PTSD beyond the Swedish language criteria and developed in an easy-to-read manner and develop the treatment so that it can be easily made available to a large number of afflicted who are excluded from treatment.The overall aim of the study is to evaluate I-PE for immigrants with PTSD living in Sweden who can read and write easy English. The treatment will be written in easy English and adapted to the target population with regards to specific contextual characteristics.
The study is a single-blind, parallel-group superiority randomized controlled trial with 100 participants that will compare I-PE with a waiting list condition. The primary outcome is the self-rated Posttraumatic Stress Disorder Checklist version 5 (PCL-5) at the 1-month follow up. Secondary outcomes are the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), self-rated symptoms of depression quality of life, dropout rate, level of health care utilization, satisfaction with treatment and negative effects. Patients in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint). Assessments will be conducted pre-treatment, post-treatment, 1 month (primary endpoint) and 6 months after treatment.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Therapist-supported internet delivered prolonged exposure
- Keywords
- PTSD, digital treatment, therapist-guided treatment, migrants, prolonged exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-supported internet delivered prolonged exposureBehavioural
Therapist-supported internet delivered prolonged exposure for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Therapist-guided internet delivered prolonged exposure | Experimental | Therapist-supported internet delivered prolonged exposure comprising psychoeducation about PTSD, controlled breathing, imaginal exposure including processing, in vivo exposure and relapse prevention. The treatment will be delivered in a digital platform for eight weeks. Participants will have access to a therapist that will guide them through treatment in a text based format. Receives: Behavioral: Therapist-supported internet delivered prolonged exposure |
| Waiting list | No intervention | Waiting list up for eight weeks and up until the 1-month follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.
Secondary outcomes (11)
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Baseline up to 1-month after treatment completion
Change in depression as assessed by The Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. Scores are calculated based on how frequently a person experiences 9 symptoms of depression ranging from "not at all" response is scored as 0; "several days" response is 1; "more than half the days" response is 2; and "nearly every day" response is 3. Higher scores represents more depressive symptoms.
Measured: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion
Change in general quality of life assessed by 12-Item Short-Form Health Survey (SF-12)
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Scores range from 0 to 100. A higher score means higher health.
Measured: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion
Treatment credibility assessed by the Credibility/expectancy scale (CEQ)
Measures treatment expectancy and rationale credibility. The CEQ is a 5-item measure of the treatment's credibility and the patients' expectations. The patients assess each domain on a 11-point likert scale (scored 0-10), with a total score ranging between 0-50 where higher score indicates higher credibility and higher expectations.
Measured: Treatment week 3 (three weeks from baseline).
Change in stigma and barriers related to mental health and competency in mental health assessed by the Stigma-9 Questionnaire (STIG-9),
The STIG-9 consists of nine items assessing cognitive, behavioural and affective aspects of perceived mental health-related stigma. The item responses are summarized in a sum score ranged 0-27 points. Higher scores indicate stronger expectations of negative societal beliefs, feelings, and behaviours towards 'mentally ill' people.
Measured: Baseline, immediately after treatment completion and 1-month after treatment completion
Change in stigma and barriers related to mental health and competency in mental health assessed Barriers to Access to Care Evaluation Scale (BACES)
The Barriers to Access to Care Evaluation (BACE) is a 30-item measure scored from 0 (not at all) to 3 (a lot) with higher scores indicating a greater barrier.
Measured: Baseline, immediately after treatment completion and 1-month after treatment completion
Change in stigma and barriers related to mental health and competency in mental health assessed Mental Health Knowledge Schedule (MHKS)
MHKS is a twelve-item scale comprising domains of relevant evidence-based knowledge in relation to stigma toward mental illness. Items are coded on an ordinal scale (1-5). Items which the respondent strongly agrees with score 5 points; 1 point reflects a response to which the respondent strongly disagrees. The total score is calculated by adding the points obtained for each of the 12 items. Higher total scores correspond to greater knowledge
Measured: Baseline, immediately after treatment completion and 1-month after treatment completion
Change in Treatment inventory of costs associated with psychiatric illness (TIC-P)
Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder. The TIC-P questionnaire measures costs in two dimensions: use of health resources and loss of productivity. Lower cost is better.
Measured: Baseline, immediately after treatment completion and 1-month after treatment completion
Treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8
The CSQ-8 yields a single score measuring a single dimension of overall satisfaction. An "overall score" is calculated by summing the score on each of the eight scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Immediately after treatment completion
Treatment satisfaction measured by the Internet Evaluation and Utility Questionnaire (IEUQ)
The Internet Evaluation and Utility Questionnaire (IEUQ) is a 13-item measure that examines the participants' experiences of a web-based intervention. Score range from 0-72. Higher values indicating higher satisfaction.
Measured: Immediately after treatment completion
Adverse events related to treatment measured by the Negative effects questionnaire-20.
Self-rated questionnaire on negative effects. It contains 20 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances. The total score of the NEQ ranges from 0 to 80 points, a higher score reflects more negative effects.
Measured: 1-mont after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Mar 2024
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Participants are randomized to I-PE for eight weeks or to a waitlist. Participants in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
- Investigators
- Maria Bragesjö, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193161
- Sponsor's protocol ID
- 2023-02715-01
- Other IDs
- 2023
- Status last verified
- Apr 2025
- First submitted
- 21 Dec 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorman K, Jayaram-Lindstrom N, Ponten M, Bragesjo M, Kolaas K, Kraepelien M, El Alaoui S, Sarnholm J, Molander O. First 100 migrants seeking culturally inclusive internet-based treatment for PTSD: a Mind the Gap pilot outreach study. BMJ Public Health. 2026 Jul 14;4(3):e003156. doi: 10.1136/bmjph-2025-003156. eCollection 2026.
PubMed 42466459Molander O, Kolaas K, Jayaram-Lindstrom N, Ponten M, Sarnholm J, Bragesjo M. Mind the gap: a nested randomised pilot study of culturally inclusive, internet-delivered prolonged exposure for PTSD among immigrants. Eur J Psychotraumatol. 2025 Dec;16(1):2520637. doi: 10.1080/20008066.2025.2520637. Epub 2025 Jun 30.
PubMed 40587567
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Internet Delivered Prolonged Exposure Immigrants With PTSD: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06193161
- Acronym / sponsor ID
- 2023-02715-01
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, digital treatment, therapist-guided treatment, migrants, prolonged exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure (I-PE) in simple english to a waiting list condition for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD).
The main objectives are to establish feasibility and preliminary efficacy of I-PE for immigrants with PTSD in a single-blind, parallel-group superiority Randomized Controlled Trial (N=100) comparing I-PE with a waiting-list condition, starting with a nested pilot (N=30) to ensure feasible and acceptable recruitment and treatment strategies. Study participants will be randomly assigned to either eight weeks of I-PE or a waiting-list for the same amount of time on a 1:1 ratio without restriction. Feasibility and acceptability data will be reported including recruitment rate, sample demographics, data attrition, treatment adherence and a detailed dropout analysis. A preliminary investigation of the within-group effect size will also be conducted. Recruitment is designed to be broadly inclusive with minimal exclusion criteria.
Detailed description
There is an urgent need for dissemination of evidence-based treatments for PTSD beyond the Swedish language criteria and developed in an easy-to-read manner and develop the treatment so that it can be easily made available to a large number of afflicted who are excluded from treatment.The overall aim of the study is to evaluate I-PE for immigrants with PTSD living in Sweden who can read and write easy English. The treatment will be written in easy English and adapted to the target population with regards to specific contextual characteristics.
The study is a single-blind, parallel-group superiority randomized controlled trial with 100 participants that will compare I-PE with a waiting list condition. The primary outcome is the self-rated Posttraumatic Stress Disorder Checklist version 5 (PCL-5) at the 1-month follow up. Secondary outcomes are the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), self-rated symptoms of depression quality of life, dropout rate, level of health care utilization, satisfaction with treatment and negative effects. Patients in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint). Assessments will be conducted pre-treatment, post-treatment, 1 month (primary endpoint) and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to I-PE for eight weeks or to a waitlist. Participants in the control arm will be crossed over to I-PE treatment after completion of the 1 month follow up (primary endpoint).
| Arm | Type | Receives |
|---|---|---|
| Therapist-guided internet delivered prolonged exposure | Experimental | Behavioral: Therapist-supported internet delivered prolonged exposureTherapist-supported internet delivered prolonged exposure comprising psychoeducation about PTSD, controlled breathing, imaginal exposure including processing, in vivo exposure and relapse prevention. The treatment will be delivered in a digital platform for eight weeks. Participants will have access to a therapist that will guide them through treatment in a text based format. |
| Waiting list | No intervention | –Waiting list up for eight weeks and up until the 1-month follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current primary diagnosis of PTSD, according to the diagnostic criteria based on Diagnostic and statistical manual of mental disorders, 5th edition (DSM-5; American Psychiatric Association, 2013)
- ≥ 18 years
- Able to read and write in English
- Immigrant residing in Sweden
- Able to provide digital informed consent
Key exclusion criteria (4 listed)
- PTSD is not the primary treatment concern
- Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention.
- Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing therapy
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 |
|---|---|---|
| Therapist-supported internet delivered prolonged exposureTherapist-supported internet delivered prolonged exposure for eight weeks. | Behavioural | Therapist-guided internet delivered prolonged exposure |
Primary outcome
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Time frame: Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
11 secondary outcomes
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
Time frame: Baseline up to 1-month after treatment completion
Change in depression as assessed by The Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion
Change in general quality of life assessed by 12-Item Short-Form Health Survey (SF-12)
Time frame: Baseline, immediately after treatment completion, 1-month and 6-month after treatment completion
Treatment credibility assessed by the Credibility/expectancy scale (CEQ)
Time frame: Treatment week 3 (three weeks from baseline).
Change in stigma and barriers related to mental health and competency in mental health assessed by the Stigma-9 Questionnaire (STIG-9),
Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion
Change in stigma and barriers related to mental health and competency in mental health assessed Barriers to Access to Care Evaluation Scale (BACES)
Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion
Change in stigma and barriers related to mental health and competency in mental health assessed Mental Health Knowledge Schedule (MHKS)
Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion
Change in Treatment inventory of costs associated with psychiatric illness (TIC-P)
Time frame: Baseline, immediately after treatment completion and 1-month after treatment completion
Treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8
Time frame: Immediately after treatment completion
Treatment satisfaction measured by the Internet Evaluation and Utility Questionnaire (IEUQ)
Time frame: Immediately after treatment completion
Adverse events related to treatment measured by the Negative effects questionnaire-20.
Time frame: 1-mont after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 42466459Sorman K, Jayaram-Lindstrom N, Ponten M, Bragesjo M, Kolaas K, Kraepelien M, El Alaoui S, Sarnholm J, Molander O. First 100 migrants seeking culturally inclusive internet-based treatment for PTSD: a Mind the Gap pilot outreach study. BMJ Public Health. 2026 Jul 14;4(3):e003156. doi: 10.1136/bmjph-2025-003156. eCollection 2026.
- Derived from this study: PubMed 40587567Molander O, Kolaas K, Jayaram-Lindstrom N, Ponten M, Sarnholm J, Bragesjo M. Mind the gap: a nested randomised pilot study of culturally inclusive, internet-delivered prolonged exposure for PTSD among immigrants. Eur J Psychotraumatol. 2025 Dec;16(1):2520637. doi: 10.1080/20008066.2025.2520637. Epub 2025 Jun 30.
- Individual participant dataSharing planned: No
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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.
Olof Molander, PhD contact
Maria Bragesjö, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-supported internet delivered prolonged exposure in people with Posttraumatic Stress Disorder, run by Karolinska Institutet 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Bragesjö, PhD (+46703399387, maria.bragesjo@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) (time frame: Baseline, through the treatment period up to eight weeks, and 1-month and 6-month after treatment completion.). 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 NCT06193161, which also lists 2 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 9 Apr 2025.