Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
Primary Purpose
Anxiety Disorders, Depressive Disorder, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Transdiagnostic Cognitive-Behavioral Treatment, Cognitive-Behavioral Treatment, Group Treatment, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- 1 SD above normal population mean on the Revised Children's Anxiety and Depression Scale (parent- or self-report), subscale or total score OR a K-SADS-PL confirmed anxiety or depressive disorder.
Exclusion Criteria:
- Inadequate language proficiency by the patient or the parent.
- The presence of other psychiatric disorders having a higher treatment priority (i.e., psychosis and acute sucide risk)
- Intellectual Disability
Sites / Locations
- Primary Health Care ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief Transdiagnostic GCBT
Waitlist
Arm Description
Participants receive Brief Transdiagnostic group cognitive-behavioral treatment. Eight weekly sessions.
Participants receive an 8-week waitlist condition with some attentional-control via monitoring for clinical deterioration. After a post-waitlist assessment, participants in this condition are offered the Brief Transiagnostic GCBT for eight weeks.
Outcomes
Primary Outcome Measures
Revised Children's Anxiety and Depression Scale (RCADS)
Self-report total score of anxiety / depression
Secondary Outcome Measures
Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS)
Parent-report total score of anxiety / depression
KINDL Quality of life, parent- and self-report
generic instrument for assessing Health-Related Quality of Life in children and adolescents
Clinical reliable change and clinical significant change
Based on the RCADS self-report using the approach by Jacobson and Truax
Full Information
NCT ID
NCT04716777
First Posted
January 19, 2021
Last Updated
November 9, 2022
Sponsor
University of Iceland
Collaborators
Primary Health Care Clinic, Reykjavik, Iceland
1. Study Identification
Unique Protocol Identification Number
NCT04716777
Brief Title
Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
Official Title
Brief Transdiagnostic Group Cognitive-Behavioral Treatment for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
January 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iceland
Collaborators
Primary Health Care Clinic, Reykjavik, Iceland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will evaluate a brief group-based cognitive-behavioral treatment program for adolescents aged 13-17 years with internalizing problems.
Detailed Description
Internalizing disorders (anxiety and depression) are among the most prevalent psychiatric disorders in youth. Cognitive-behavioral treatment (CBT) is well-establed treatment for internalizing disorders. The evidence originates mostly from disorder-specific CBT for youth. However, the validity of specific diagnosis has been questioned, especially because of high symptom overlap between disorders and the high rates of diagnostic comorbidity. In addition, research has suggested that depressive comorbidity is associated with reduced treatment effectiveness for primary anxiety disorder and vice versa. A recent meta-analysis, of the collective evidence of psychotherapy throught 50 years, revealed that there were no effects of disorder-specific psychotherapy for youths with one or more comorbid disorder. Which indicates that disorder-specific treatment is not sufficient for children with comorbidity.
Transdiagnostic treatments have been developed and evaluated to address this problem. These treatments emphasize effective therapeutic principles which may be applied across multiple disorders. Transidagnostic treatment may be more cost effective and practical than disorder-specific treatments as most therapists only need to be trained extensively in one protocol. Transdiagnostic treatments may also be easily learned by clinicians and especially in generalist settings where one transdiagnostic protocol can be offered to patients with various mental health problems instead of many offered to much fewer. Offering transdiagnostic treatment approach may better serve the diagnostically heterogeneous groups which seek help at general clinics instead of many different disorder-specific treatment protocols. Transdiagnostic CBT protocols have been proved to be effective among adults with internalizing disorders and also among youths. It has also been showed that transdiagnostic CBT was equally effective as anxiety disorder-specific protocol for adults with anxiety disorders.
Treatment Our treatment is a brief group-based cognitive-behavioral treatment which was specifically designed for adolescents with impairing internalizing symptoms, or anxiety/depressive disorders seeking help at the Primary Health Care Clinics in Iceland. The treatment comprises eight weekly 110-minutes sessions were the following components are applied: (1) psychoeducation, (2) cognitive restructuring, (3), behavioral activation, (4) exposure, (5) problem solving, (6) social skills, and (7) mindfulness. The participants receive a workbook with outline of each sessions and assignments related to components (e.g., (e.g., ABC workseets, exposure exercises). They are encouraged to practice skills learned in sessions between sessions. All parents attend two sessions. They receive detailed psychoeducation and are instructed in assisting their children with the homework assignments (week 1), and in week 6 they are instructed how to assist their children with exposure exercises. They also receive a workbook with outline of each sessions. The therapist also has at least one telephone call with each family to follow-up on exercises.
Study design and participants The following study is a randomized controlled trial where participants are allocated to either eight weekly sessions of brief transidagnostic CBT or waitlist monitoring for clinical deterioration. The investigators will randomize by using blockwise procedure determined by a computer-generated algorithm. To ensure that the randomization will not be predicted in advance, it will be centralized at the University of Iceland. Participants will be assigned to study group after being deemed eligible and undergoing consent.
Assessment Participants will be assessed at baseline, midtreatment, posttreatment (week 8), 2 months follow-up, 4 months follow-up, and 1-year follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depressive Disorder, Anxiety, Depression
Keywords
Transdiagnostic Cognitive-Behavioral Treatment, Cognitive-Behavioral Treatment, Group Treatment, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of two conditions 8-week treatment or 8-week waitlist.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brief Transdiagnostic GCBT
Arm Type
Experimental
Arm Description
Participants receive Brief Transdiagnostic group cognitive-behavioral treatment. Eight weekly sessions.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants receive an 8-week waitlist condition with some attentional-control via monitoring for clinical deterioration. After a post-waitlist assessment, participants in this condition are offered the Brief Transiagnostic GCBT for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
Intervention Description
Weekly group-based transdiagnostic CBT sessions for eight weeks.
Primary Outcome Measure Information:
Title
Revised Children's Anxiety and Depression Scale (RCADS)
Description
Self-report total score of anxiety / depression
Time Frame
Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)
Secondary Outcome Measure Information:
Title
Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS)
Description
Parent-report total score of anxiety / depression
Time Frame
Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)
Title
KINDL Quality of life, parent- and self-report
Description
generic instrument for assessing Health-Related Quality of Life in children and adolescents
Time Frame
Measured at baseline and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)
Title
Clinical reliable change and clinical significant change
Description
Based on the RCADS self-report using the approach by Jacobson and Truax
Time Frame
Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1 SD above normal population mean on the Revised Children's Anxiety and Depression Scale (parent- or self-report), subscale or total score OR a K-SADS-PL confirmed anxiety or depressive disorder.
Exclusion Criteria:
Inadequate language proficiency by the patient or the parent.
The presence of other psychiatric disorders having a higher treatment priority (i.e., psychosis and acute sucide risk)
Intellectual Disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gudmundur Skarphedinsson, PhD
Phone
003545525573
Email
gskarp@hi.is
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gudmundur Skarphedinsson, PhD
Organizational Affiliation
University of Iceland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Care Clinic
City
Reykjavik
ZIP/Postal Code
112
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunnar Karlsson, MSc
Phone
003545135200
Email
gkk@simnet.is
First Name & Middle Initial & Last Name & Degree
Gunnar Karlsson, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
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