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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Depression
• Intervention / Treatment: Behavioral: A metacognitive group therapy of depression and anxiety in youth with autism

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timo Hursti, Ph.D.; Phone Number: 46 184717842; Email: timo.hursti@psyk.uu.se

Study Locations

• Sweden
  • Stockholm County
    • Haninge, Stockholm County, Sweden, 13640
      • Recruiting
      • PRIMA Child and Youth Psychiatry, Handen
      • Contact: Markus Björnström; Email: markus.bjornstrom@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metacognitions Questionnaire - 30 items version (MCQ-30)	A self-report measuring metacognitive assumptions and processes.	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Cognitive Attentional Syndrome Scale (CAS-1)	A self-report measuring the presence of Cognitive Attentional Syndrome	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Child Sheehan Disability Scale (CSDS)	A subjective appraisal of functional impairment related to familial, social and vocational aspects of life.	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Brunnsviken Brief Quality of life questionnaire (BBQ)	Measure of quality of life with a total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Perceived Stress Scale 10 (PSS-10)	A questionnaire that aims to measure symptoms of stress. It contains 10 items that are scored on a range between 0 (never) to 4 (very often). The total score range is between 0-40 and a higher score reflects higher levels of perceived stress.	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Effects Questionnaire, 20 items Child (NEQ 20C)	A self-report measuring negative effects of the treatment and some aspects related to acceptability.	After treatment completion at 10 weeks.

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Timo Hursti, Ph.D., Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: UUMCT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No