IBA Treatment in Adolescents With OCD

NCT05547334 | Unknown

• 2 other identifiers: 217-22NL81157.091.22
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder in Adolescence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in OCD symptomatology

  three-weekly questions during the intervention

• Treatment history (psychotherapy and medication)

  T0 = Study intake (baseline phase)

• Change in current medication use

  through study completion, an average of 9 months

Study Arms (1)

A non-concurrent multiple baseline design

OTHER

A non-concurrent multiple baseline design

Behavioral: Inference Based Approach (IBA)

Interventions

Inference Based Approach (IBA) BEHAVIORAL

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.

A non-concurrent multiple baseline design

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Karakter Kinder- en Jeugdpsychiatrie: lead

Central Study Contacts

L.A.A.C. Webers, Msc

CONTACT

06-31915818; l.webers@karakter.com

H Klip, Phd

CONTACT

06-31915818; h.klip@karakter.com

Study Design

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

Model Details: A non-concurrent multiple baseline design

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share