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

Anxiety Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441786
• Other study ID #: UUMCT001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 12, 2024
• Est. completion date: August 29, 2025

Study information

• Verified date: May 2024
• Source: Uppsala University
• Contact: Timo Hursti, Ph.D.
• Phone: +46184717842
• Email: timo.hursti[@]psyk.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: August 29, 2025
• Est. primary completion date: August 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Depression
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	PRIMA Child and Youth Psychiatry, Handen	Haninge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	Brunnsviken Brief Quality of life questionnaire (BBQ)	A self-report measuring experienced quality of life.	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Perceived Stress Scale 10 (PSS-10)	A self-report measuring subjective stress.	Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.