A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism

Официальное название

A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism: Feasibility, Acceptability and Effect in a Clinical Open Trial

Обзор

The goal of this open clinical trial is to try out and evaluate a group metacognitive treatment protocol, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis. The main questions it aims to answer are: 1. How does the recruitment to the study work and what is the retention rate? 2. What is the level of participant compliance? 3. Is the treatment adherence satisfactory, are there any practical problems with treatment delivery? 4. Are the outcome measures and assessment procedures feasible? 5. Do the participants accept the treatment, are there any reports of adverse effects? 6. What are the preliminary effects of the treatment regarding 1. Symptoms of anxiety and/or depression 2. Quality of life 3. Functional impairment 4. Subjective level of stress 5. Central metacognitive processes 7. Are changes in metacognitive processes related to changes in anxiety and depression? The participants will partake in metacognitive group treatment of 10 sessions following an initial screening.

Подробное описание

Participants in the study are youth (15 to 18 years of age) seeking help for anxiety and depression within child and youth psychiatry. There will a consecutive inclusion to form 6 treatment groups with 6 persons in each. The groups will meet once every week. Assessments will take place at pre- and post-treatment as well as at 6-month follow-up. Some metacognitive processes will also be monitored at each group session. The therapists have undergone a specialist training in metacognitive therapy and are experienced in using the methods. The main focus of the study is on feasibility, acceptability and preliminary effects of the treatment. These will be analyzed with paired sample t-test on primary and secondary outcomes.

Вмешательства

• Поведенческое A metacognitive group therapy of depression and anxiety in youth with autism
  The treatment model is based on Adrian Wells' transdiagnostic A-M-C model and treatment structure described in Wells (2009) "Metacognitive therapy for anxiety and depression". The group treatment is delivered in 10 weekly sessions.

Первичные конечные точки

• Revised Children's Anxiety and Depression Scale (RCADS) [Срок оценки: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up]

Вторичные конечные точки (5)

• Brunnsviken Brief Quality of life questionnaire (BBQ) [Срок оценки: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up]
• Metacognitions Questionnaire - 30 items version (MCQ-30) [Срок оценки: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up]
• Cognitive Attentional Syndrome Scale (CAS-1) [Срок оценки: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up]
• Child Sheehan Disability Scale (CSDS) [Срок оценки: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up]
• Perceived Stress Scale 10 (PSS-10) [Срок оценки: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.]

Критерии участия

Критерии включения

• Age of 15 to 18 years
• Seeking medical care PRIMA psychiatric clinic for children and youth in Stockholm
• Diagnoses of anxiety disorder or depression as well as autism established in a clinical interview
• Mastering the Swedish language enough to take part of the treatment
• Willingness/ability to participate after receiving information about what participation entails

Критерии исключения

• Assessed to meet one of the following diagnoses: Bipolar syndrome, alcohol use syndrome, substance use syndromes, psychotic symptoms and affective syndromes with psychotic symptoms and antisocial personality disorder.
• Assessed to have a high suicide risk.
• Assessed to have extensive self-harm behavior or moderate to high risk of such.
• Participating in other psychological treatment or about to start such treatment during the time interval of the study.
• Has not had stable medication in the last month or is planning a deposit/medication adjustment during the time interval of the study.

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

• PRIMA Child and Youth Psychiatry, Handen — Haninge

Идентификаторы

NCT: NCT06441786 · UUMCT001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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