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NCT Number: NCT06441786

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

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.

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Key information

Conditions

Anxiety Depression

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PRIMA Child and Youth Psychiatry, Handen

Haninge, Stockholm County, 13640, Sweden

Location status: Recruiting

Location contact

Markus Björnström

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Revised Children's Anxiety and Depression Scale (RCADS)

    Time frame: 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 outcomes

  1. Brunnsviken Brief Quality of life questionnaire (BBQ)

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

    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.

  2. Metacognitions Questionnaire - 30 items version (MCQ-30)

    Time frame: 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.

  3. Cognitive Attentional Syndrome Scale (CAS-1)

    Time frame: 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

  4. Child Sheehan Disability Scale (CSDS)

    Time frame: 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.

  5. Perceived Stress Scale 10 (PSS-10)

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

    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.

Other outcomes

  1. Negative Effects Questionnaire, 20 items Child (NEQ 20C)

    Time frame: After treatment completion at 10 weeks.

    A self-report measuring negative effects of the treatment and some aspects related to acceptability.

Study contacts

Contact information is provided by the study sponsor or research team.

Timo Hursti, Ph.D.

CONTACT

[email protected]

46 184717842

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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