NCT07465354

Brief Summary

The aim of the study is to examine the effectiveness of OCD treatment delivered in a group format for adolescents during a two week intensive summer treatment program.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
89mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Last Updated

March 18, 2026

Status Verified

October 1, 2025

Enrollment Period

4.3 years

First QC Date

March 6, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

Obsessive-compulsive disorderAdolescentsintensive cognitive-behavioral treatmentExposure and response prevention

Outcome Measures

Primary Outcomes (4)

  • Behavioral Rating Inventory of Executive Function (BRIEF)

    A questionnaire designed to assess executive functioning in children and adolescents aged 5 to 18 years (Gioia et al., 2000). The questionnaire consists of 86 items with three response options: never = 1, sometimes = 2, and often = 3. A higher score on the BRIEF indicates greater executive functioning difficulties. The first 72 items are divided into eight clinical subscales that measure different aspects of executive function. These clinical subscales fall under two broader indices: the Behavioral Regulation Index (BRI) and the Metacognition Index (MI), which together form a Global Executive Composite (GEQ) score. The psychometric properties of the Icelandic version have proven to be acceptable.

    Baseline, 1 week after treatment, 6 month follow-up, 12 month follow-up

  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

    This is a semi-structured interview (Scahill et al., 1997) intended to assess the symptoms and severity of obsessive compulsive disorder in children and adolescents aged 6-17 years. The scores range from 0-40, a higher score indicating more OCD related impairment with a clinical cut-off score of 15. The interview is conducted either with both the child and parent present or, in some cases, separately. The interview method depends, among other things, on the child´s age and developmental level. This interview is widely used, both for clinical purposes and in research, and has been translated into many languages. Today, it is considered the gold standard for assessing the severity of OCD symptoms and treatment response and is the most commonly and widely accepted tool for such evaluations (Mataix-Cols et al, 2016; Skarphedinsson et al, 2017). The interview has demonstrated strong psychometric properties (Cook et al., 2015; Højgaard et al., 2017).

    Baseline, 1 week after treatment, 6 month follow-up, 12 month follow-up

  • The Child Obsessive-Compulsive Impact Scale (COIS-R)

    This is a 55-item questionnaire that assesses functional impairment due to OCD in the child's most important environments (home, school, and social situations) (Piacentini et al, 2007). Each question is rated on a Likert scale from 0-3 and a higher score indicates more OCD related impairment. The adolescents will complete the child/adolescent form and parents will complete the parent form.

    Baseline, 1 week after treatment, 6 month follow-up, 12 month follow-up

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

    This is a commonly used questionnaire to screen for anxiety and depressive disorders and to assess changes following an intervention. The RCADS is a 47-item questionnaire designed for parents and children (ages 8-17) and includes the following scales: Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, and Depressive Symptoms. Items are rated on a four-point scale and higher scores indicate more difficulties: 0 = never, 1 = sometimes, 2 = often, 3 = always. The Icelandic version has acceptable psychometric properties in both general and clinical populations.

    Baseline, 1 week after treatment, 6 month follow-up, 12 month follow-up

Secondary Outcomes (1)

  • Family Accommodation Scale for OCD- Self-Rated (FAS-SR)

    Baseline, 1 week after treatment, 6 month follow-up, 12 month follow-up

Study Arms (1)

Intensive group-based cognitive-behavioral treatment

EXPERIMENTAL

This cognitive-behavioral exposure / response prevention program is delivered intensively over two consecutive weeks, consisting of daily 2.5-hour sessions across 10 days. Each group includes 6-8 adolescents, with every participant paired with an individual therapist for each session, though therapists rotate daily. At the outset, adolescents receive workbooks and psychoeducation on the nature of obsessive thoughts and compulsive behaviors, along with strategies to manage symptoms and reduce impairment. The primary focus of the program is individualized exposure exercises conducted with a therapist during each session. Designed for adolescents aged 12-18, the program also includes parent sessions, in which parents learn to manage anxiety-driven behaviors at home and reduce family accommodation.

Behavioral: Intensive cognitive-behavioral treatment with exposure / response prevention

Interventions

This cognitive-behavioral exposure / response prevention program is delivered intensively over two consecutive weeks, consisting of daily 2.5-hour sessions across 10 days. Each group includes 6-8 adolescents, with every participant paired with an individual therapist for each session, though therapists rotate daily. At the outset, adolescents receive workbooks and psychoeducation on the nature of obsessive thoughts and compulsive behaviors, along with strategies to manage symptoms and reduce impairment. The primary focus of the program is individualized exposure exercises conducted with a therapist during each session. Designed for adolescents aged 12-18, the program also includes parent sessions, in which parents learn to manage anxiety-driven behaviors at home and reduce family accommodation.

Intensive group-based cognitive-behavioral treatment

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • OCD diagnosis
  • Adolescents are fluent in Icelandic
  • Parents are fluent in Icelandic or English

You may not qualify if:

  • Intellectual disability
  • Severe suicidal ideation
  • Acute psychiatric disorders requiring immediate intervention, e.g. schizophrenia
  • Severely impairing levels of autism prohibiting group participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iceland

Reykjavik, 102, Iceland

Location

Related Publications (1)

  • Selles RR, Belschner L, Negreiros J, Lin S, Schuberth D, McKenney K, Gregorowski N, Simpson A, Bliss A, Stewart SE. Group family-based cognitive behavioral therapy for pediatric obsessive compulsive disorder: Global outcomes and predictors of improvement. Psychiatry Res. 2018 Feb;260:116-122. doi: 10.1016/j.psychres.2017.11.041. Epub 2017 Nov 15.

    PMID: 29179016BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Central Study Contacts

Dagmar Kr. Hannesdottir, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study uses a longitudinal within subjects' design to examine the effectiveness of an intensive group-based OCD treatment among adolescents in Iceland. Participants will answer a set of questionnaires and interviews at four time points: pre-treatment, post-treatment, 6-month follow-up, 12-month follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2033

Last Updated

March 18, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

As the study includes repeated measures of a clinical child population, parts of the data will be classified as sensitive personal data and thus restricted by the permit from the National Bioethics Committee of Iceland.

Locations