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

NCT ID: NCT06441786

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2026-08-29

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.

Conditions

Anxiety Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A metacognitive group therapy of depression and anxiety in youth with autism

A 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.

Group Type: EXPERIMENTAL

A metacognitive group therapy of depression and anxiety in youth with autism

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timo Hursti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

PRIMA Child and Youth Psychiatry, Handen

Haninge, Stockholm County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Timo Hursti, Ph.D.

Role: CONTACT

timo.hursti@psyk.uu.se

46 184717842

Facility Contacts

Markus Björnström

Role: primary

markus.bjornstrom@gmail.com

Other Identifiers

UUMCT001

Identifier Type: -

Identifier Source: org_study_id