MedPath

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

Not Applicable
Not yet recruiting
Conditions
Anxiety Depression
Interventions
Behavioral: A metacognitive group therapy of depression and anxiety in youth with autism
Registration Number
NCT06441786
Lead Sponsor
Uppsala University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
36
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
A metacognitive group therapy of depression and anxiety in youth with autismA metacognitive group therapy of depression and anxiety in youth with autismA within group design where one clinical manualized intervention, Metacognitive therapy (MCT) for anxiety and depression, is offered in a 10-session group format to adolescents. The therapists have received special training in MCT and are experienced in using the methods. The treatment is delivered face-to-face.
Primary Outcome Measures
NameTimeMethod
Revised Children's Anxiety and Depression Scale (RCADS)Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

A self-report that measures symptoms of anxiety and depression.

Secondary Outcome Measures
NameTimeMethod
Brunnsviken Brief Quality of life questionnaire (BBQ)Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

A self-report measuring experienced quality of life.

Cognitive Attentional Syndrome Scale (CAS-1)Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

A self-report measuring the presence of Cognitive Attentional Syndrome

Metacognitions Questionnaire - 30 items version (MCQ-30)Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

A self-report measuring metacognitive assumptions and processes.

Child Sheehan Disability Scale (CSDS)Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

A subjective appraisal of functional impairment related to familial, social and vocational aspects of life.

Perceived Stress Scale 10 (PSS-10)Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.

A self-report measuring subjective stress.

Trial Locations

Locations (1)

PRIMA Child and Youth Psychiatry, Handen

πŸ‡ΈπŸ‡ͺ

Haninge, Stockholm, Sweden

Β© Copyright 2025. All Rights Reserved by MedPath