Anxiety DepressionNCT06441786
A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism
A study testing A metacognitive group therapy of depression and anxiety in youth with autism in people with Anxiety Depression, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- A metacognitive group therapy of depression and anxiety in youth with autism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- 12 Aug 2024to 29 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
PRIMA Child and Youth Psychiatry, Handen
Haninge, Stockholm County, 13640
Markus Björnström, markus.bjornstrom@gmail.com
About this study
Official title: 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:
Read more
- How does the recruitment to the study work and what is the retention rate?
- What is the level of participant compliance?
- Is the treatment adherence satisfactory, are there any practical problems with treatment delivery?
- Are the outcome measures and assessment procedures feasible?
- Do the participants accept the treatment, are there any reports of adverse effects?
- What are the preliminary effects of the treatment regarding
- Symptoms of anxiety and/or depression
- Quality of life
- Functional impairment
- Subjective level of stress
- Central metacognitive processes
- 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.
Read the 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
- Being tested
- A metacognitive group therapy of depression and anxiety in youth with autism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A metacognitive group therapy of depression and anxiety in youth with autismBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: A metacognitive group therapy of depression and anxiety in youth with autism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Children's Anxiety and Depression Scale (RCADS)
A self-report that measures symptoms of anxiety and depression.
Measured: 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)
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.
Measured: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Metacognitions Questionnaire - 30 items version (MCQ-30)
A self-report measuring metacognitive assumptions and processes.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start12 Aug 2024
- Primary completion29 Aug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timo Hursti, Ph.D., Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441786
- Sponsor's protocol ID
- UUMCT001
- Status last verified
- Sep 2025
- First submitted
- 28 May 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism: Feasibility, Acceptability and Effect in a Clinical Open Trial
- ClinicalTrials.gov ID
- NCT06441786
- Acronym / sponsor ID
- UUMCT001
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How does the recruitment to the study work and what is the retention rate?
- What is the level of participant compliance?
- Is the treatment adherence satisfactory, are there any practical problems with treatment delivery?
- Are the outcome measures and assessment procedures feasible?
- Do the participants accept the treatment, are there any reports of adverse effects?
- What are the preliminary effects of the treatment regarding
- Symptoms of anxiety and/or depression
- Quality of life
- Functional impairment
- Subjective level of stress
- Central metacognitive processes
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A metacognitive group therapy of depression and anxiety in youth with autism | Experimental | Behavioral: A metacognitive group therapy of depression and anxiety in youth with autismA 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. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A metacognitive group therapy of depression and anxiety in youth with autismThe 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. | Behavioural | A metacognitive group therapy of depression and anxiety in youth with autism |
Primary outcome
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.
5 secondary outcomes
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
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
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
Child Sheehan Disability Scale (CSDS)
Time frame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timo Hursti, Ph.D. principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A metacognitive group therapy of depression and anxiety in youth with autism in people with Anxiety Depression, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timo Hursti, Ph.D. (46 184717842, timo.hursti@psyk.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.