Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441786
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism Feasibility Acceptability and Effect in a Clinical Open Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None