NCT06441786

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 15 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety Depression

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2024-08-12
• Primary completion: 2026-08-29
• Completion: 2026-08-29
• First posted: 2024-06-04
• Last updated: 2025-09-29

Locations

1 site across 1 country: Sweden