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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

Brief Summary:
We will evaluate a brief group-based cognitive-behavioral treatment program for adolescents aged 13-17 years with internalizing problems.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Depressive Disorder Anxiety Depression Behavioral: Brief Transdiagnostic group-based Cognitive-Behavioral Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Brief Transdiagnostic Group Cognitive-Behavioral Treatment for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : May 20, 2022
Estimated Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Brief Transdiagnostic GCBT
Participants receive Brief Transdiagnostic group cognitive-behavioral treatment. Eight weekly sessions.
Behavioral: Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
Weekly group-based transdiagnostic CBT sessions for eight weeks.

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.



Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716777


Contacts
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Contact: Gudmundur Skarphedinsson, PhD 003545525573 gskarp@hi.is

Locations
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Iceland
Primary Health Care Clinic Recruiting
Reykjavik, Iceland, 112
Contact: Gunnar Karlsson, MSc    003545135200    gkk@simnet.is   
Principal Investigator: Gunnar Karlsson, MSc         
Sponsors and Collaborators
University of Iceland
Primary Health Care Clinic, Reykjavik, Iceland
Investigators
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Principal Investigator: Gudmundur Skarphedinsson, PhD University of Iceland
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Responsible Party: University of Iceland
ClinicalTrials.gov Identifier: NCT04716777    
Other Study ID Numbers: VSN-20-115
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Iceland:
Transdiagnostic Cognitive-Behavioral Treatment
Cognitive-Behavioral Treatment
Group Treatment
Randomized Controlled Trial
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Pathologic Processes
Mental Disorders
Mood Disorders