Feasibility of Group-Based Metacognitive Therapy for PTSD

Официальное название

A Feasibility Study of Group-Based Metacognitive Therapy (MCT) for Post-Traumatic Stress Disorder (PTSD) in a Routine Healthcare Setting

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• The proportion of participants that conducts the weekly measures and further assessment points [Срок оценки: Through study completion up to the 6 months follow up]
• The proportion of participants that go through the entire treatment period [Срок оценки: Completion of treatment period, up to the last session delivered 14 weeks after treatment start]
• Adverse events related to the treatment [Срок оценки: Through study completion, up to the 6 months follow up]
• Acceptability [Срок оценки: Completion of treatment period, up to the last session delivered 14 weeks after treatment start]
• Treatment acceptability [Срок оценки: Baseline]
• Treatment acceptability [Срок оценки: Up to 6 months after treatment completion]
• Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8). [Срок оценки: Up till treatment completion, 14 weeks after treatment start]
• Treatment adherence [Срок оценки: Up to treatment completion, 14 weeks after treatment start.]

Вторичные конечные точки (7)

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Срок оценки: 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). [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Immediately after treatment completion, at 3-month and 6-months follow up after treatment completion.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst — Stockholm

Идентификаторы

NCT: NCT07302334 · 2025-03111-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗