PTSDNCT07302334
Feasibility of Group-Based Metacognitive Therapy for PTSD
A study testing Group-based metacognitive therapy in people with PTSD, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective of this study is to investigate the feasibility and acceptability of group-based Metacognitive Therapy (MCT) for post-traumatic stress disorder (PTSD) when delivered within routine psychiatric care in Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Group-based metacognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 28 Nov 2025to 28 Nov 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
- Fulfills the diagnostic criteria for PTSD based on clinical records
- Self-rated total sum score over 30 on the PCL-5
- Age ≥18 years.
- Stable psychotropic medication regimen for ≥4 weeks.
- Fluent in Swedish.
Who cannot join
- Severe psychiatric comorbidities (e.g., suicidal ideation, active psychosis, bipolar disorder) warranting immediate attention.
- Current trauma-related threat (e.g., ongoing domestic violence).
- Ongoing evidence-based trauma-focused psychological treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst
Stockholm, 14157
Maria Bragesjö, PhD and licensed psychologist, 0046 8585 804 45, maria.bragesjo@ki.se
About this study
Official title: A Feasibility Study of Group-Based Metacognitive Therapy (MCT) for Post-Traumatic Stress Disorder (PTSD) in a Routine Healthcare Setting
The primary objective of this study is to investigate the feasibility and acceptability of group-based Metacognitive Therapy (MCT) for post-traumatic stress disorder (PTSD) when delivered within routine psychiatric care in Sweden.
The secondary objective is to evaluate preliminary treatment effects of group-based MCT on symptoms of post-traumatic stress, complex PTSD, depression, and quality of life, and to compare treatment dropout rates to those reported in the existing literature on exposure-based treatments for PTSD.
Read the detailed description
The investigators will investigate a 14 weekly group-based Metacognitive Therapy (MCT) for post-traumatic stress disorder (PTSD). Feasibility and acceptability outcomes include recruitment and retention rates, data completeness, treatment adherence, and qualitative evaluations of patient experiences. 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. The investigators hypothesize that group-based MCT will result in significant within-group reductions in PTSD and depressive symptoms and improvements in functioning and quality of life from pre- to post-treatment, with effects maintained up to the 6-month follow-up.
- Conditions
- PTSD
- Being tested
- Group-based metacognitive therapy
- Keywords
- PTSD, MCT
- 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.
Group-based metacognitive therapyBehavioural
Group-based metacognitive therapy will be offered for 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group-based metacognitive therapy | Experimental | 14 weeks of group-based meta-cognitive therapy Receives: Behavioral: Group-based metacognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants that conducts the weekly measures and further assessment points
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
The proportion of participants that go through the entire treatment period
Measured: Completion of treatment period, up to the last session delivered 14 weeks after treatment start
Adverse events related to the treatment
Adverse events related to the treatment
Measured: Through study completion, up to the 6 months follow up
Acceptability
Number of drop-outs from treatment
Measured: Completion of treatment period, up to the last session delivered 14 weeks after treatment start
Treatment acceptability
Number of individuals offered the intervention but declined part of treatment
Measured: Baseline
Treatment acceptability
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Measured: Up to 6 months after treatment completion
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: Up till treatment completion, 14 weeks after treatment start
Treatment adherence
The proportion of completed group-sessions
Measured: Up to treatment completion, 14 weeks after treatment start.
Secondary outcomes (7)
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: At baseline, after seven weeks of treatment, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
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: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
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: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
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: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in tendency to engage in excessive, uncontrollable, and generalized worry measured by PSWQ
Change in tendency to engage in excessive and uncontrollable worry from baseline to post-treatment and follow-up.
The Penn State Worry Questionnaire (PSWQ) is a standardized self-report measure assessing the general tendency to experience persistent, excessive, and uncontrollable worry. It measures the extent to which worry is perceived as pervasive, distressing, and difficult to control across situations. The scale consists of 16 items rated on a 5-point Likert scale ranging from 1 ("not at all typical of me") to 5 ("very typical of me"). Items reflect frequency, intensity, and uncontrollability of worry. Higher scores indicate a greater tendency toward pathological worry.
Measured: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in general anxiety level measured by GAD-7
Change in The Generalized Anxiety Disorder scale (GAD-7), a standardized self-report measure of general anxiety symptoms. It consists of 7 items assessing the frequency of core anxiety symptoms such as excessive worry, tension, restlessness, irritability, and difficulties relaxing or concentrating. Respondents rate how often they have been bothered by each symptom over the past two weeks on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Total scores range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: At baseline, immediately after treatment completion, at 3-month and 6-months follow up 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: Immediately after treatment completion, at 3-month and 6-months follow up 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 posted24 Dec 2025
- Study start28 Nov 2025
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Meta-cognitive therapy will be offered in a group-based format for 14 weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302334
- Sponsor's protocol ID
- 2025-03111-01
- Other IDs
- 2025
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Group-Based Metacognitive Therapy (MCT) for Post-Traumatic Stress Disorder (PTSD) in a Routine Healthcare Setting
- ClinicalTrials.gov ID
- NCT07302334
- Acronym / sponsor ID
- 2025-03111-01
- Conditions
- PTSD
- Keywords
- PTSD, MCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 24 Dec 2025 (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 of this study is to investigate the feasibility and acceptability of group-based Metacognitive Therapy (MCT) for post-traumatic stress disorder (PTSD) when delivered within routine psychiatric care in Sweden.
The secondary objective is to evaluate preliminary treatment effects of group-based MCT on symptoms of post-traumatic stress, complex PTSD, depression, and quality of life, and to compare treatment dropout rates to those reported in the existing literature on exposure-based treatments for PTSD.
Detailed description
The investigators will investigate a 14 weekly group-based Metacognitive Therapy (MCT) for post-traumatic stress disorder (PTSD). Feasibility and acceptability outcomes include recruitment and retention rates, data completeness, treatment adherence, and qualitative evaluations of patient experiences. 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. The investigators hypothesize that group-based MCT will result in significant within-group reductions in PTSD and depressive symptoms and improvements in functioning and quality of life from pre- to post-treatment, with effects maintained up to the 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Meta-cognitive therapy will be offered in a group-based format for 14 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group-based metacognitive therapy | Experimental | Behavioral: Group-based metacognitive therapy14 weeks of group-based meta-cognitive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfills the diagnostic criteria for PTSD based on clinical records
- Self-rated total sum score over 30 on the PCL-5
- Age ≥18 years.
- Stable psychotropic medication regimen for ≥4 weeks.
- Fluent in Swedish.
Key exclusion criteria (3 listed)
- Severe psychiatric comorbidities (e.g., suicidal ideation, active psychosis, bipolar disorder) warranting immediate attention.
- Current trauma-related threat (e.g., ongoing domestic violence).
- Ongoing evidence-based trauma-focused psychological treatment
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 |
|---|---|---|
| Group-based metacognitive therapyGroup-based metacognitive therapy will be offered for 14 weeks. | Behavioural | Group-based metacognitive therapy |
Primary outcome
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 conducts the weekly measures and further assessment points
The proportion of participants that go through the entire treatment period
Time frame: Completion of treatment period, up to the last session delivered 14 weeks after treatment start
The proportion of participants that go through the entire treatment period
Adverse events related to the treatment
Time frame: Through study completion, up to the 6 months follow up
Adverse events related to the treatment
Acceptability
Time frame: Completion of treatment period, up to the last session delivered 14 weeks after treatment start
Number of drop-outs from treatment
Treatment acceptability
Time frame: Baseline
Number of individuals offered the intervention but declined part of treatment
Treatment acceptability
Time frame: Up to 6 months after treatment completion
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Time frame: Up till treatment completion, 14 weeks after treatment start
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.
Treatment adherence
Time frame: Up to treatment completion, 14 weeks after treatment start.
The proportion of completed group-sessions
7 secondary outcomes
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Time frame: At baseline, after seven weeks of treatment, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
Time frame: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in quality of life measured by Euroqol, EQ-5D
Time frame: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in tendency to engage in excessive, uncontrollable, and generalized worry measured by PSWQ
Time frame: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Change in general anxiety level measured by GAD-7
Time frame: At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.
Adverse events related to treatment measured by the Negative effects questionnaire-20.
Time frame: Immediately after treatment completion, at 3-month and 6-months follow up 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 24 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based metacognitive therapy in people with PTSD, 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: looking for participants now, as of the sponsor's last update on 24 Dec 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 (+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?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.