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Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial

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ClinicalTrials.gov Identifier: NCT04716777
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Primary Health Care Clinic, Reykjavik, Iceland
Information provided by (Responsible Party):
University of Iceland

Tracking Information
First Submitted Date  ICMJE January 19, 2021
First Posted Date  ICMJE January 20, 2021
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE October 15, 2020
Estimated Primary Completion Date May 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
  • Revised Children's Anxiety and Depression Scale (RCADS) [ Time Frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    The RCADS self-report total score of anxiety / depression
  • Change over time in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Measured at week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    CGI-I is an independent evaluator rated measure of improvement in symptoms and functioning. It has a total range from 1-7 with the lower scores indicating more improvement in functioning.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
  • Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS) [ Time Frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    The RCADS parent-report total score of anxiety / depression
  • KINDL Quality of life, parent- and self-report [ Time Frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    generic instrument for assessing Health-Related Quality of Life in children and adolescents
  • Child Behavior Checklist and Youth Self Report [ Time Frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    Broad band scales that combine several of the syndrome scales
  • Clinical reliable change and clinical significant change [ Time Frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    Based on the RCADS self-report using the approach by Jacobson and Truax
  • Change over time in Clinical Global Impression-Severity (CGI-S) [ Time Frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial) ]
    CGI-S is an independent evaluator rated measure of improvement in symptoms and functioning. It has a total range from 1-7 with the lower scores indicating more improvement in functioning.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
Official Title  ICMJE Brief Transdiagnostic Group Cognitive-Behavioral Treatment for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
Brief Summary We 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 (1, 2). Cognitive-behavioral treatment (CBT) is well-establed treatment for internalizing disorders (10-13). The evidence originates mostly from disorder-specific CBT for youth [e.g., (14, 15)]. However, the validity of specific diagnosis has been questioned, especially because of high symptom overlap between disorders (16-19) and the high rates of diagnostic comorbidity (20, 21). In addition, research has suggested that depressive comorbidity is associated with reduced treatment effectiveness for primary anxiety disorder (22-24) and vice versa (18). 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 (25). 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 (26, 27). 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 (28). 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 (25, 29). Transdiagnostic CBT protocols have been proved to be effective among adults with internalizing disorders (30-33) and also among youths (34-37) It has also been showed that transdiagnostic CBT was equally effective as anxiety disorder-specific protocol for adults with anxiety disorders (38)

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. We 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to one of two conditions 8-week treatment or 8-week waitlist.
Masking: Single (Outcomes Assessor)
Masking Description:
Independent evaluator will rate response/remission using the CGI-I/S
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • Depressive Disorder
  • Anxiety
  • Depression
Intervention  ICMJE Behavioral: Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
Weekly group-based transdiagnostic CBT sessions for eight weeks.
Study Arms  ICMJE
  • Experimental: Brief Transdiagnostic GCBT
    Participants receive Brief Transdiagnostic group cognitive-behavioral treatment. Eight weekly sessions.
    Intervention: Behavioral: Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
  • No Intervention: Waitlist
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 20, 2023
Estimated Primary Completion Date May 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gudmundur Skarphedinsson, PhD 003545525573 gskarp@hi.is
Listed Location Countries  ICMJE Iceland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04716777
Other Study ID Numbers  ICMJE VSN-20-115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Iceland
Study Sponsor  ICMJE University of Iceland
Collaborators  ICMJE Primary Health Care Clinic, Reykjavik, Iceland
Investigators  ICMJE
Principal Investigator: Gudmundur Skarphedinsson, PhD University of Iceland
PRS Account University of Iceland
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP