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Feasibility of Group-Based Metacognitive Therapy for PTSD

NCT ID: NCT07302334

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2026-11-28

Brief Summary

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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

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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

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PTSD

Keywords

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PTSD MCT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Meta-cognitive therapy will be offered in a group-based format for 14 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group-based metacognitive therapy

14 weeks of group-based meta-cognitive therapy

Group Type EXPERIMENTAL

Group-based metacognitive therapy

Intervention Type BEHAVIORAL

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

Interventions

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Group-based metacognitive therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Maria Bragesjo

Prinicipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria Bragesjö

Role: CONTACT

Phone: +46703399387

Email: [email protected]

Facility Contacts

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Maria Bragesjö, PhD and licensed psychologist

Role: primary

Other Identifiers

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2025-03111-01

Identifier Type: -

Identifier Source: org_study_id