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

NCT04716777 | Unknown DMC

• 1 other identifier: VSN-20-115
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate a brief group-based cognitive-behavioral treatment program for adolescents aged 13-17 years with internalizing problems.

Conditions

Anxiety Disorders; Depressive Disorder; Anxiety; Depression

Keywords

Transdiagnostic Cognitive-Behavioral Treatment; Cognitive-Behavioral Treatment; Group Treatment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Revised Children's Anxiety and Depression Scale (RCADS)

  Self-report total score of anxiety / depression

  Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

Secondary Outcomes (3)

• Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS)

  Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

• KINDL Quality of life, parent- and self-report

  Measured at baseline and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

• Clinical reliable change and clinical significant change

  Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

Study Arms (2)

Brief Transdiagnostic GCBT

EXPERIMENTAL

Participants receive Brief Transdiagnostic group cognitive-behavioral treatment. Eight weekly sessions.

Behavioral: Brief Transdiagnostic group-based Cognitive-Behavioral Treatment

Waitlist

NO INTERVENTION

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.

Interventions

Brief Transdiagnostic group-based Cognitive-Behavioral Treatment BEHAVIORAL

Weekly group-based transdiagnostic CBT sessions for eight weeks.

Brief Transdiagnostic GCBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iceland: lead
• Primary Health Care Clinic, Reykjavik, Iceland: collaborator

Study Sites (1)

Primary Health Care Clinic

Reykjavik, 112, Iceland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gudmundur Skarphedinsson, PhD

  University of Iceland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gudmundur Skarphedinsson, PhD

CONTACT

003545525573; gskarp@hi.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two conditions 8-week treatment or 8-week waitlist.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: October 15, 2020
• Primary Completion: January 20, 2023
• Study Completion: September 20, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)