Clinical trial NCT06441786: A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism
Official title: A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism: Feasibility, Acceptability and Effect in a Clinical Open Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Depression
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
Secondary outcomes:
measure: Brunnsviken Brief Quality of life questionnaire (BBQ)
timeFrame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
measure: Metacognitions Questionnaire - 30 items version (MCQ-30)
timeFrame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
measure: Cognitive Attentional Syndrome Scale (CAS-1)
timeFrame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
measure: Child Sheehan Disability Scale (CSDS)
timeFrame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up
measure: Perceived Stress Scale 10 (PSS-10)
timeFrame: Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up.
Other outcomes:
measure: Negative Effects Questionnaire, 20 items Child (NEQ 20C)
timeFrame: After treatment completion at 10 weeks.
Locations:
city: Haninge
country: Sweden
facility: PRIMA Child and Youth Psychiatry, Handen
state: Stockholm
Study officials:
affiliation: Uppsala University
name: Timo Hursti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: