A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism
ConditionAnxiety Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-18
SponsorUppsala University
About this 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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
A metacognitive group therapy of depression and anxiety in youth with autism
BehavioralThe 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.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: A metacognitive group therapy of depression and anxiety in youth with autismExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Revised Children's Anxiety and Depression Scale (RCADS)
A self-report that measures symptoms of anxiety and depression.
Time frame
Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-upSecondary outcomes
1
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.
Time frame
Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up2
Metacognitions Questionnaire - 30 items version (MCQ-30)
A self-report measuring metacognitive assumptions and processes.
Time frame
Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up3
Cognitive Attentional Syndrome Scale (CAS-1)
A self-report measuring the presence of Cognitive Attentional Syndrome
Time frame
Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up4
Child Sheehan Disability Scale (CSDS)
A subjective appraisal of functional impairment related to familial, social and vocational aspects of life.
Time frame
Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-upOther outcomes
1
Negative Effects Questionnaire, 20 items Child (NEQ 20C)
A self-report measuring negative effects of the treatment and some aspects related to acceptability.
Time frame
After treatment completion at 10 weeks.Sponsors and contacts
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Source ClinicalTrials.gov