Post Traumatic Stress DisorderNCT05207462
A Feasibility Study of Intensive Treatment With Prolonged Exposure
A study testing Intensive treatment with prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Intensive treatment with prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 24 Jan 2022to 22 Jul 2023
- 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
- Meet criteria for PTSD
- If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry
- ≥ 18 years
- Fluent in Swedish
- Signed informed consent
Who cannot join
- Other serious comorbidity as primary concern (for example ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, high suicidal risk)
- Other ongoing trauma-focused psychological treatment
- Ongoing trauma-related threat (e.g. living with a violent spouse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting
The primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. The secondary objective is to investigate preliminary effects of i-PE in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
Read the detailed description
The investigators will investigate I-PE delivered as a one-week intensive treatment consisting of nine individual sessions and five group sessions followed by three individual session two, four and eight weeks afterwards in a pilot trial. The feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. The individual sessions will consist of imaginal exposure and processing and the group sessions of psychoeducation, rationale for treatment and in vivo exposure work. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialised in PTSD in Stockholm, Sweden.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Intensive treatment with prolonged exposure
- Keywords
- PTSD, prolonged exposure, intensive treatment, massed treatment
- 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.
Intensive treatment with prolonged exposureBehavioural
Intensive treatment with prolonged exposure
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment with prolonged exposure | Experimental | Intensive treatment with prolonged exposure Receives: Behavioral: Intensive treatment with prolonged exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of imaginal exposures made by the participant during the treatment period
Measured: Through treatment, up to the last session delivered eight weeks after the massed treatment week
Number of in vivo exposures made by the participant during the treatment period
Measured: Through treatment, up to up to the last session delivered eight weeks after the massed treatment week
The proportion of participants that conducts the weekly measures and further assessment points
Measured: Through study completion up to the 6 months follow up
The proportion of participants that go through the entire treatment period
Measured: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Adverse events related to the treatment
Treatment acceptability
Measured: Through study completion, up to the 6 months follow up
Number of drop-outs from treatment
Treatment acceptability
Measured: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Number of individuals offered the intervention but declined part of treatment
Treatment acceptability
Measured: Baseline
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Qualitative interviews
Measured: Completion of the massed treatment period up to post-treatment
Participants satisfaction with treatment, assessed 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: Completion of the massed treatment period (one week)
Secondary outcomes (5)
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: Pre-treatment, 6 months follow up
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, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
The ITQ includes six items measuring each PTSD symptom cluster and these items measure how bothersome each symptom has been in the past month. The ITQ also includes six items measuring each 'Disturbance in Self-Organization' (DSO) symptom in complex PTSD. These items measure how a respondent typically feels, thinks about oneself, and relates to others. The PTSD and DSO symptoms are accompanied by three items measuring associated functional impairments in the domains of social, occupation, and other important areas of life. All items are answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Thus, PTSD and DSO symptom scores range from 0 to 24 and CPTSD symptom scores range from 0 to 48. Higher scores represents more PTSD and complex PTSD symptoms.
Measured: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (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, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Change in quality of life measured by Euroqol, EQ-5D
Change in overall health from baseline to post treatment and follow up . EQ-5D is a standardized self-report measure of overall health status measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a three-level scale: 1 having no problems, 2 having some problems and 3 having extreme problems. A higher score indicate worse severity.
Measured: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start24 Jan 2022
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prolonged exposure will be offered in a massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 2, 4 and 8 weeks afterwards.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
- Investigators
- Maria Bragesjö, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207462
- Sponsor's protocol ID
- 2021-06004-01
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jamil S, Ruck C, Bragesjo M. Feasibility of intensive prolonged exposure for PTSD: a pragmatic pilot study in Swedish public outpatient psychiatry. BMC Psychiatry. 2026 Jan 27;26(1):181. doi: 10.1186/s12888-026-07836-1.
PubMed 41593574
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting
- ClinicalTrials.gov ID
- NCT05207462
- Acronym / sponsor ID
- 2021-06004-01
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, prolonged exposure, intensive treatment, massed treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 26 Jan 2022 (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 primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. The secondary objective is to investigate preliminary effects of i-PE in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
Detailed description
The investigators will investigate I-PE delivered as a one-week intensive treatment consisting of nine individual sessions and five group sessions followed by three individual session two, four and eight weeks afterwards in a pilot trial. The feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. The individual sessions will consist of imaginal exposure and processing and the group sessions of psychoeducation, rationale for treatment and in vivo exposure work. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialised in PTSD in Stockholm, Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prolonged exposure will be offered in a massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 2, 4 and 8 weeks afterwards.
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment with prolonged exposure | Experimental | Behavioral: Intensive treatment with prolonged exposureIntensive treatment with prolonged exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet criteria for PTSD
- If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry
- ≥ 18 years
- Fluent in Swedish
- Signed informed consent
Key exclusion criteria (3 listed)
- Other serious comorbidity as primary concern (for example ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, high suicidal risk)
- Other ongoing trauma-focused psychological treatment
- Ongoing trauma-related threat (e.g. living with a violent spouse)
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 |
|---|---|---|
| Intensive treatment with prolonged exposureIntensive treatment with prolonged exposure | Behavioural | Intensive treatment with prolonged exposure |
Primary outcome
Number of imaginal exposures made by the participant during the treatment period
Time frame: Through treatment, up to the last session delivered eight weeks after the massed treatment week
Number of in vivo exposures made by the participant during the treatment period
Time frame: Through treatment, up to up to the last session delivered eight weeks after the massed treatment week
The proportion of participants that conducts the weekly measures and further assessment points
Time frame: Through study completion up to the 6 months follow up
The proportion of participants that go through the entire treatment period
Time frame: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Adverse events related to the treatment
Time frame: Through study completion, up to the 6 months follow up
Treatment acceptability
Number of drop-outs from treatment
Time frame: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Treatment acceptability
Number of individuals offered the intervention but declined part of treatment
Time frame: Baseline
Treatment acceptability
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Time frame: Completion of the massed treatment period up to post-treatment
Qualitative interviews
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Time frame: Completion of the massed treatment period (one week)
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.
5 secondary outcomes
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
Time frame: Pre-treatment, 6 months follow up
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Time frame: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
Time frame: Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
Change in quality of life measured by Euroqol, EQ-5D
Time frame: Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.
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 7 Dec 2023.
- Derived from this study: PubMed 41593574Jamil S, Ruck C, Bragesjo M. Feasibility of intensive prolonged exposure for PTSD: a pragmatic pilot study in Swedish public outpatient psychiatry. BMC Psychiatry. 2026 Jan 27;26(1):181. doi: 10.1186/s12888-026-07836-1.
- 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. This study is not recruiting at the moment.
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 Intensive treatment with prolonged exposure in people with Post Traumatic 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 5 inclusion and 3 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 7 Dec 2023. 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?
Number of imaginal exposures made by the participant during the treatment period (time frame: Through treatment, up to the last session delivered eight weeks after the massed treatment week). The study lists 9 primary outcomes in all. 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 NCT05207462, which also lists 1 linked publication.
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 7 Dec 2023.