Feasibility of Group-Based Metacognitive Therapy for PTSD

NCT07302334 | Recruiting

• 1 other identifier: 2025-03111-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PTSD

Keywords

PTSD; MCT

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  Through study completion, up to the 6 months follow up

• Acceptability

  Number of drop-outs from treatment

  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

  Baseline

• Treatment acceptability

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

  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.

  Up till treatment completion, 14 weeks after treatment start

• Treatment adherence

  The proportion of completed group-sessions

  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)

  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).

  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)

  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

  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

  At baseline, immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.

Other Outcomes (1)

• Dropout Rates

  Immediately after treatment completion

Study Arms (1)

Group-based metacognitive therapy

EXPERIMENTAL

14 weeks of group-based meta-cognitive therapy

Behavioral: Group-based metacognitive therapy

Interventions

Group-based metacognitive therapy BEHAVIORAL

Group-based metacognitive therapy will be offered for 14 weeks.

Group-based metacognitive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: collaborator
• Karolinska Institutet: lead

Study Sites (1)

Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst

Stockholm, 14157, Sweden

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Maria Bragesjö

CONTACT

+46703399387; maria.bragesjo@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Model Details: Meta-cognitive therapy will be offered in a group-based format for 14 weeks.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 24, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

SE (1)