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

NCT06441786 | Recruiting

• 1 other identifier: UUMCT001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.How does the recruitment to the study work and what is the retention rate?
2. 2.What is the level of participant compliance?
3. 3.Is the treatment adherence satisfactory, are there any practical problems with treatment delivery?
4. 4.Are the outcome measures and assessment procedures feasible?
5. 5.Do the participants accept the treatment, are there any reports of adverse effects?
6. 6.What are the preliminary effects of the treatment regarding
7. 7.Symptoms of anxiety and/or depression
8. 8.Quality of life
9. 9.Functional impairment
10. 10.Subjective level of stress
11. 11.Central metacognitive processes
12. 12.Are changes in metacognitive processes related to changes in anxiety and depression?

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• Revised Children's Anxiety and Depression Scale (RCADS)

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

  Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

Secondary Outcomes (5)

• Brunnsviken Brief Quality of life questionnaire (BBQ)

  Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

• Metacognitions Questionnaire - 30 items version (MCQ-30)

  Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

• Cognitive Attentional Syndrome Scale (CAS-1)

  Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

• Child Sheehan Disability Scale (CSDS)

  Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up

• Perceived Stress Scale 10 (PSS-10)

  Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.

Other Outcomes (1)

• Negative Effects Questionnaire, 20 items Child (NEQ 20C)

  After treatment completion at 10 weeks.

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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

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

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

PRIMA Child and Youth Psychiatry, Handen

Haninge, Stockholm County, 13640, Sweden

RECRUITING

Study Officials

• Timo Hursti, Ph.D.

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timo Hursti, Ph.D.

CONTACT

46 184717842; timo.hursti@psyk.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A clinical open trial evaluating feasibility, acceptability, as well as treatment effects measured before, after and at 6-month follow-up, for a 10-week group treatment based on metacognitive therapy, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis. The study is conducted at two psychiatric clinics for children and youth. The treatment structure was adjusted before the inclusion of Group 4 (Sep 2026), resulting in three individual sessions and five group sessions.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

SE (1)