Feasibility of Group-Based Metacognitive Therapy for PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group-based metacognitive therapy.
- Who it may be relevant to
- Registry conditions: PTSD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Study of Group-Based Metacognitive Therapy (MCT) for Post-Traumatic Stress Disorder (PTSD) in a Routine Healthcare Setting
Overview
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.
Interventions
- Behavioral Group-based metacognitive therapy
Group-based metacognitive therapy will be offered for 14 weeks.
Primary outcome measures
- 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 14 weeks after treatment start]
- Adverse events related to the treatment [Time frame: Through study completion, up to the 6 months follow up]
- Acceptability [Time frame: Completion of treatment period, up to the last session delivered 14 weeks after treatment start]
- Treatment acceptability [Time frame: Baseline]
- Treatment acceptability [Time frame: Up to 6 months after treatment completion]
- Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8). [Time frame: Up till treatment completion, 14 weeks after treatment start]
- Treatment adherence [Time frame: Up to treatment completion, 14 weeks after treatment start.]
Secondary outcome measures (7)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst — Stockholm
Identifiers
NCT: NCT07302334 · 2025-03111-01