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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
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timo Hursti, Ph.D. | Contact | 46 184717842 | timo.hursti@psyk.uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Timo Hursti, Ph.D. | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRIMA Child and Youth Psychiatry, Handen | Recruiting | Haninge | Stockholm County | 13640 | Sweden |
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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.
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|
| 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 |
| 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. |