IBA Treatment in Adolescents With OCD

Effect of Inference Based Approach in Adolescents With OCD

Adolescents with Obsessive-compulsive Disorder (OCD) have obsessions, compulsions or both. OCD is a severe psychiatric disorder, affecting many aspects of the lives of adolescents. The first choice treatment for adolescents with OCD is Cognitive Behavioral Therapy (CBT), consisting of exposure with response prevention (ERP) and cognitive interventions. Considering the substantial group of non-responders to CBT, it is necessary to have more options for effective treatment of OCD. Inference Based Approach (IBA) is already an effective treatment for adults with OCD and is more effective on adults with OCD and poor cognitive insight. It is hypothesized that IBA could be an effective alternative for CBT in treating adolescents with OCD. This study will be a first step in examining the efficacy of IBA as treatment for adolescents with OCD.

The aim of this study is to explore the potential efficacy of IBA as treatment for adolescents with OCD using a non-concurrent multiple baseline design with 8 participants who receive IBA for 20 sessions performed in one psychiatric centre in the Netherlands.

Study Overview

• Status: Not yet recruiting
• Conditions: Obsessive-Compulsive Disorder in Adolescence
• Intervention / Treatment: Behavioral: Inference Based Approach (IBA)

Detailed Description

Background of the study:

Adolescents with Obsessive-compulsive Disorder (OCD) have obsessions, compulsions or both (APA, 2014). OCD is a severe psychiatric disorder, affecting many aspects of the lives of adolescents (Weidle et al., 2014; Storch et al., 2018). The first choice treatment for adolescents with OCD is Cognitive Behavioral Therapy (CBT), consisting of exposure with response prevention (ERP) and cognitive interventions (Öst et al., 2016). Treating adolescents with OCD through CBT leads to significant symptom reduction in almost 70% of completed treatments (Öst et al., 2016). However, after completion of treatment, about 50% of adolescents still meet the criteria for OCD (Öst et al., 2016). Adolescents with OCD who do not sufficiently benefit from CBT treatment have severe symptoms, including poor or no insight (Sharma et al., 2021; Nissen & Parner, 2018; Storch et al., 2014). Considering the substantial group of non-responders to CBT, it is necessary to have more options for effective treatment of OCD. Inference Based Approach (IBA) is already an effective treatment for adults with OCD (O'Connor et al., 2005; Visser et al., 2015) and is more effective on adults with OCD and poor cognitive insight (Visser et al., 2015). It is hypothesized that IBA could be an effective alternative for CBT in treating adolescents with OCD. This study will be a first step in examining the efficacy of IBA as treatment for adolescents with OCD.

Objective of the study:

The aim of this study is to explore the potential efficacy of IBA as treatment for adolescents with OCD.

Study design:

A non-concurrent multiple baseline design with 8 participants who receive IBA for 20 sessions perfomed in one psychiatric centre in the Netherlands.

Study population:

8 adolescents from 12 to 17;11 years old with a Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) diagnosis of OCD and a total score of 16 or higher on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). All adolescents included in this study completed an evidence-based treatment for OCD prior to participation.

Intervention (if applicable):

20 sessions IBA treatment.

Primary study parameters/outcome of the study:

Severity of OCD, measured with the CY-BOCS;

Secondary study parameters/outcome of the study (if applicable):

OCD symptomatology, measured with three-weekly ratings of the adolescents' obsessions, compulsions and the level of insight.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

No burden or risks are expected due to specific elements of the IBA intervention used in this study. Contrary to CBT, treatment elements of IBA will not include exposure to feared consequences while trying to not indulge in compulsions. On top of that, obsessions will not be questioned or challenged. These characteristics may help participants stay motivated to complete treatment and experience improvement in OCD-symptoms.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: L.A.A.C. Webers, Msc; Phone Number: 06-31915818; Email: l.webers@karakter.com
• Study Contact Backup: Name: H Klip, Phd; Phone Number: 06-31915818; Email: h.klip@karakter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Primary DSM-5 diagnosis of OCD.
• A total score of 16 or higher on the CY-BOCS.
• Age between 12 and 17;11.
• A completed evidence-based treatment for OCD.
• Medication must be stable for at least one month.

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• No sufficient knowledge of the Dutch language
• Autism spectrum disorder (ASD)**
• Mental retardation (TIQ<80)**

• Acute suicidality (defined as having suicidal thoughts and plans and/or preparations to ending their life)

  • In case of ASD and/or mental retardation, the IBA protocol maybe too challenging. It is expected that the included cognitive elements, specifically when abstract reasoning is asked, will ask too much of these subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: A non-concurrent multiple baseline design

Behavioral: Inference Based Approach (IBA); The Inference Based Approach (IBA) (as described by Visser et al., 2015 and adapted for use in adolescents by L. Webers)is a focused form of psychotherapy consists of twenty 45-minutes sessions, delivered weekly and carried out as specified in a Dutch session-by-session IBA protocol, containing standardized forms for exercises and homework assignments. Each session has a standard format, starting with agenda setting and evaluating homework assignments, followed by determining and executing a new exercise and determining new homework. The IBA model is based on the assumption that adolescents with OCD and poor inside misjudge the actual state of affairs. It is assumed that certain reasoning processes lead to these erroneous conclusions and distract the childs attention from observable reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in severity of OCD	measured with the CY-BOCS at T0 = Study intake (baseline phase);T1 = Start treatment phase; i.e. start IBA treatment; T2 = Post-treatment assessment (after IBA treatment); T3 = Follow-up 3 months post-treatment	through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in OCD symptomatology	measured with three-weekly ratings of the adolescents' obsessions, compulsions and the level of insight.	three-weekly questions during the intervention
Treatment history (psychotherapy and medication)	Treatment history (psychotherapy and medication)	T0 = Study intake (baseline phase)
Change in current medication use	Current medication use at T0 = Study intake (baseline phase) T1 = Start treatment phase; i.e. start IBA treatment T2 = Post-treatment assessment (after IBA treatment) T3 = Follow-up 3 months post-treatment	through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: Karakter Kinder- en Jeugdpsychiatrie

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): November 1, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (ACTUAL): September 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 217-22; NL81157.091.22 (REGISTRY: ToetsingOnline)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No