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IBA Treatment in Adolescents With OCD

Primary Purpose

Obsessive-Compulsive Disorder in Adolescence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inference Based Approach (IBA)
Sponsored by
Karakter Kinder- en Jeugdpsychiatrie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder in Adolescence

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    A non-concurrent multiple baseline design

    Arm Description

    A non-concurrent multiple baseline design

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Change in OCD symptomatology
    measured with three-weekly ratings of the adolescents' obsessions, compulsions and the level of insight.
    Treatment history (psychotherapy and medication)
    Treatment history (psychotherapy and medication)
    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

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 20, 2022
    Sponsor
    Karakter Kinder- en Jeugdpsychiatrie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05547334
    Brief Title
    IBA Treatment in Adolescents With OCD
    Official Title
    Effect of Inference Based Approach in Adolescents With OCD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Karakter Kinder- en Jeugdpsychiatrie

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder in Adolescence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A non-concurrent multiple baseline design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A non-concurrent multiple baseline design
    Arm Type
    Other
    Arm Description
    A non-concurrent multiple baseline design
    Intervention Type
    Behavioral
    Intervention Name(s)
    Inference Based Approach (IBA)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in severity of OCD
    Description
    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
    Time Frame
    through study completion, an average of 9 months
    Secondary Outcome Measure Information:
    Title
    Change in OCD symptomatology
    Description
    measured with three-weekly ratings of the adolescents' obsessions, compulsions and the level of insight.
    Time Frame
    three-weekly questions during the intervention
    Title
    Treatment history (psychotherapy and medication)
    Description
    Treatment history (psychotherapy and medication)
    Time Frame
    T0 = Study intake (baseline phase)
    Title
    Change in current medication use
    Description
    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
    Time Frame
    through study completion, an average of 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    L.A.A.C. Webers, Msc
    Phone
    06-31915818
    Email
    l.webers@karakter.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    H Klip, Phd
    Phone
    06-31915818
    Email
    h.klip@karakter.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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