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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Maria Bragesjö contact

+46703399387

maria.bragesjo@ki.se

Sweden1 site, 1 recruiting
  • Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst

    Stockholm, 14157

    Maria Bragesjö, PhD and licensed psychologist, 0046 8585 804 45, maria.bragesjo@ki.se

    Recruiting

Other trials in Sweden

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 groups in NCT07302334
Study groupRoleWhat they receive
Group-based metacognitive therapyExperimental14 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.

  1. 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

  2. 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

  3. Adverse events related to the treatment

    Adverse events related to the treatment

    Measured: Through study completion, up to the 6 months follow up

  4. Acceptability

    Number of drop-outs from treatment

    Measured: Completion of treatment period, up to the last session delivered 14 weeks after treatment start

  5. Treatment acceptability

    Number of individuals offered the intervention but declined part of treatment

    Measured: Baseline

  6. Treatment acceptability

    Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews

    Measured: Up to 6 months after treatment completion

  7. 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

  8. Treatment adherence

    The proportion of completed group-sessions

    Measured: Up to treatment completion, 14 weeks after treatment start.

Secondary outcomes (7)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  1. First posted24 Dec 2025
  2. Study start28 Nov 2025
  3. Primary completion28 Aug 2026 (estimated)
  4. Study completion28 Nov 2026 (estimated)

Resources

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)
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

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.

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