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Alternative Treatment to Reduce Chronicity in OCD: Research Into Brain Response and Adequacy of Treatment (arrIBA)

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ClinicalTrials.gov Identifier: NCT03929081
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
VU University Medical Center
GGZ inGeest
PsyQ
Radboud University
Information provided by (Responsible Party):
GGZ Centraal

Brief Summary:

Rationale: Obsessive-Compulsive Disorder (OCD) is a disabling neuropsychiatric disorder that often has a chronic disease course. The standard psychotherapeutic treatment Cognitive Behavioural Therapy (CBT) is unable to redeem about half of all patients and is rejected by many because of its anxiety provoking methods. A promising alternative is the Interference Based Approach (IBA), which appears to be as effective as CBT, and more effective for patients with poor insight. The current study will investigate the proposed IBA non-inferiority to CBT. Furthermore, the neurobiological working mechanisms of both treatments will be investigated. Both treatment modalities are expected to alter activity and connectivity in different functional brain networks. In order to lead the way towards personalized care for OCD patients, clinical and neurobiological predictors of response to treatment will be studied. The eventual aim of this study is to prevent the demoralizing effect of undergoing an ineffective treatment by future prediction of whether an individual patient will respond better to IBA or CBT. This also contributes to solving the costs and waiting times for CBT.

Objective: To investigate non-inferiority of IBA compared to CBT and to unravel the neurobiological working mechanisms of both treatment modalities.

Study design: Multicentre randomized controlled trial.

Study population: 203 adults with a primary diagnosis of OCD and 43 healthy controls, matched on gender, age and educational level.

Intervention: The 203 adults with the primary diagnosis of OCD will be divided into the experimental- (IBA) and control intervention (CBT). Healthy controls will not receive an intervention.

Main study parameters/endpoints: Clinical measures (e.g. severity of OCD symptoms, disease insight), neurocognitive capabilities (performance on neuropsychological tests), neural correlates on brain structure (i.e. white matter integrity, grey matter volume) and brain function (i.e., activation and connectivity during resting state and symptom provocation) using 3 Tesla magnetic resonance imaging.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Inference Based Approach (IBA) Behavioral: Cognitive Behavioural Therapy (CBT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter, randomized controlled non-inferiority trial. 203 OCD patients will be recruited. During intake for treatment, patients willing to participate, will be invited for a baseline visit, after the Informed Consent process (IC). Then the patient will be randomized to 20 sessions IBA or 20 sessions CBT. Randomization ratio is 1:1, stratified by site. OCD symptom severity will be assessed by a blind assessor at baseline, after 20 sessions, and 6 and 12 months after posttest. Further, OCD symptom severity and insight in OCD symptoms will be assessed (self-report) weekly. To explore working mechanisms, 43 patients of each treatment arm will receive pre- and posttreatment brain imaging and neuropsychological assessment. After randomization, patients are screened for MRI eligibility, until the sufficient amount of participants is reached. A complementary IC will be signed. 43 healthy controls will receive a single brain imaging and neuropsychological testing session.
Masking: Single (Investigator)
Masking Description: The research assessors will be blinded for treatment allocation. Partcipants and clinicians will be requested not to reveal information about treatment allocation to the assessors.
Primary Purpose: Treatment
Official Title: Alternative Treatment to Reduce Chronicity in OCD: Research Into Brain Response and Adequacy of Treatment A Randomized Controlled Non-inferiority Trial Into the Effectiveness and Working Mechanisms of IBA in Comparison to CBT.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inference Based Approach (IBA)
The IBA treatment, a focused form of psychotherapy consists of twenty 45-minutes sessions, delivered weekly. The IBA model is based on the assumption that patients with OCD feel the need to perform compulsive acts because they misjudge the actual state of affairs, for example fearing that an appliance is on when it is visibly off. It is assumed that certain reasoning processes lead to these erroneous conclusions and distract the patient's attention from observable reality. IBA teaches patients how to defend themselves against the absorbing and confusing effect of obsessive reasoning processes and how to stay in touch with reality by actively relying on the sensory information of the very moment. As a consequence, the patient realizes that any compulsive act is superfluous and feels able to omit it.
Behavioral: Inference Based Approach (IBA)
The Inference Based Approach aims at strengthening reality testing in patients with Obsessive-Compulsive Disorder, by teaching the patient to actively rely on sensory information.
Other Name: Psychotherapy

Active Comparator: Cognitive Behavior Therapy (CBT)
In the control condition, the patients will receive twenty 45-minutes sessions of CBT consisting of self-guided exposure in vivo with response prevention (ERP) and cognitive therapy (CT), both standardized according to evidence-based session-by-session protocols, containing standardized forms for exercises and homework assignments.
Behavioral: Cognitive Behavioural Therapy (CBT)
CBT teaches the patient with Obsessive-Compulsive Disorder to refrain from compulsive acts.
Other Name: Psychotherapy

No Intervention: No intervention (healthy controls)
The healthy control group will receive no intervention.



Primary Outcome Measures :
  1. Change from baseline score on the Yale Brown Obsessive Compulsive Scale (YBOCS) after 20 sessions IBA or CBT, and after 6 months and 1 year post treatment [ Time Frame: at baseline; post intervention at week 20; at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    The YBOCS (range 0-40, higher values representing worse outcome) measures OCD symptom severity


Secondary Outcome Measures :
  1. Change from baseline brain morphology measured by Magnetic Resonance Imaging (MRI) after 20 sessions IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    Morphologic characteristics of grey matter, e.g. cortical thickness and surface area.

  2. Change from baseline structural connectivity measured by Diffusion Tensor Imaging (DTI) after 20 sessions IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    White matter integrity

  3. Change from baseline activity and functional connectivity measured by resting state functional Magnetic Resonance Imaging (rs-fMRI) after 20 sessions IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    Activity and functional connectivity based on the BOLD response during rest

  4. Change from baseline activity and functional connectivity measured by functional Magnetic Resonance Imaging (fMRI) during OCD symptom provocation after 20 sessions IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    Activity and functional connectivity based on the BOLD response during symptom provocation; watching OCD-related, general fear-related and neutral images

  5. Change from baseline score on the Overvalued Ideas Scale (OVIS) after 20 sessions IBA or CBT, and after 6 months and 1 year post treatment [ Time Frame: at baseline; post intervention at week 20; at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    The OVIS (range 0-10, higher scores representing worse outcome) measures level of insight in OCD symptoms

  6. Change form baseline on the Yale-Brown Obsessive Compulsive Scale self-report questionnaire (YBOCS-SR) after each therapy session IBA or CBT [ Time Frame: at baseline; at every therapy session at week 0-20 ]
    The YBOCS-SR (range 0-40, higher scores representing worse outcome) measures severity of OCD symptoms

  7. Change from baseline on the Overvalued Ideas Scale - Self Report (OVIS-SR) [ Time Frame: at baseline; at every therapy session at week 0-20 ]
    The OVIS-SR (range 0-10, higher scores representing worse outcome) measures level of insight in OCD symptoms

  8. Treatment Acceptability/Adherence Scale (TAAS) [ Time Frame: at baseline after randomization ]
    The TAAS (range10-70, higher scores representing more tolerability) measures tolerability of treatment

  9. Treatment Acceptability/Adherence Scale (TAAS) [ Time Frame: mid intervention at week 10 ]
    The TAAS (range10-70, higher scores representing more tolerability) measures tolerability of treatment

  10. Treatment Acceptability/Adherence Scale (TAAS) [ Time Frame: post intervention at week 20 ]
    The TAAS (range10-70, higher scores representing more tolerability) measures tolerability of treatment

  11. Change from baseline performance on Tower of London Task (ToL) after 20 sessions of IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    ToL measures executive functioning (planning)

  12. Change from baseline performance on Visual Spatial N-back Task after 20 sessions of IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    Visual Spatial N-back Task measures executive functioning (updating)

  13. Change from baseline performance on Stop Signal Task (SST) after 20 sessions of IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    SST measures executive functioning (response inhibition)

  14. Change from baseline score on the Beck Depression Inventory (BDI), after 10 sessions IBA or CBT, at post treatment after 20 sessions IBA or CBT and after 6 months and 1 year post treatment [ Time Frame: at baseline;mid-treatment at week 10; post intervention at week 20; at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    BDI (range 0-63, higher scores representing worse outcome) measures severity of depressive symptoms

  15. Change from baseline score on the Beck Anxiety Inventory (BDI), after 10 sessions IBA or CBT, at post treatment after 20 sessions IBA or CBT and after 6 months and 1 year post treatment [ Time Frame: at baseline;mid-treatment at week 10; post intervention at week 20;at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    BAI(range 0-63, higher scores representing worse outcome) measures severity of depressive symptoms

  16. Change from baseline score on Euroquol, after 10 sessions IBA or CBT, at post treatment after 20 sessions IBA or CBT and after 6 months and 1 year post treatment [ Time Frame: at baseline;mid-treatment at week 10; post intervention at week 20; at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    Euroquol (range 0-1, higher scores representing better outcome) measures quality of life

  17. Change from baseline score on Sheehan disability Scale (SDS), after 10 sessions IBA or CBT, at post treatment after 20 sessions IBA or CBT and after 6 months and 1 year post treatment [ Time Frame: at baseline;mid-treatment at week 10; post intervention at week 20; at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    SDS (range 0-30, higher scores representing worse outcome) measures disability/impairment in work, social life or leisure activities and home life or family responsibilities

  18. Change from baseline score on Relationship Satisfaction Scale (RSS), after 10 sessions IBA or CBT, at post treatment after 20 sessions IBA or CBT and after 6 months and 1 year post treatment [ Time Frame: at baseline;mid-treatment at week 10; post intervention at week 20; at follow up 6 months post week 20; at follow up 12 months post week 20 ]
    RSS (range 9-45, higher scores representing better outcome) measures relationship satisfaction


Other Outcome Measures:
  1. Change on performance on the Confidence Accuracy Task after 20 sessions of IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    Confidence Accuracy Task measures the confidence a participant has in his/her own visual perception

  2. Change of valence rating of symptom provocation stimuli after 20 sessions of IBA or CBT [ Time Frame: at baseline; post intervention at week 20 ]
    The subjective valence of OCD-related, general fear-related and neutral images rate on a 1-5 scale (not unpleasant - highly unpleasant)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants

  • Referred to one of the participating sites for OCD treatment
  • Age 18 or above
  • Primary Diagnostic Statistical Manual (DSM)-5 diagnosis of OCD (established by the Structured Clinical Interview for DSM-5 (SCID)
  • Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale Brown Obsessive Compulsive Scale (YBOCS)
  • Not currently using psychotropic medication, or on a stable dose for at least 12 weeks prior to randomisation with no plans to change the dose during the course of the study (this will be monitored during the study)
  • If CBT already has been received for OCD, treatment has ended at least 26 weeks before study participation.

Controls

- Age 18 or above

Exclusion Criteria:

Patients

  • Suffering from a current psychotic disorder, organic mental disorder, substance use disorder or mental retardation
  • No sufficient command of the Dutch language

Patients will be asked if they are willing to participate in the imaging study as well, including brain scans pre- and posttreatment. The selection will continue until 86 eligible participants are included for the MRI part of the study. Additional exclusion criteria apply for this sub study:

  • Use of psychotropic medication other than Selective Serotonin Reuptake Inhibitor/Selective Norepinephrine Reuptake Inhibitor/clomipramine (e.g. antipsychotics). Occasional (not daily, a maximal equivalent of 10 mg. diazepam at a time) use of benzodiazepines/sleeping medication is allowed, if the participant is willing to tolerate to refrain from use for at least a week before the MRI scanning session, and able to tolerate this period of refrainment.
  • Pregnancy
  • Iron in the body
  • Claustrophobia
  • Any known neurological diseases (including epilepsy) or brain surgery
  • Head trauma that resulted in unconsciousness for at least 1 hour
  • Age 65 or above
  • Controls
  • Age 65 or above
  • Current DSM-5 diagnosis (established by the SCID)
  • Personal history of DSM-5 diagnosis, except for depressive or anxiety disorder longer than 12 months ago
  • Personal history or current use of psychotropic medication (excluding sporadic use of sedatives/benzodiazepines, not having been used the week prior to participation
  • First-degree relative (parent/sibling/child) with OCD or tic-disorder
  • Insufficient command of the Dutch language
  • Pregnancy
  • Iron in the body
  • Claustrophobia
  • Any known neurological diseases (including epilepsy), or past brain surgery
  • Head trauma that resulted in unconsciousness for at least 1 hour

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929081


Contacts
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Contact: Henny Visser, PhD +31 (0)6-12742856 h.visser1@ggzcentraal.nl
Contact: Nadja Wolf, Msc +31 (0)6-51340224 n.wolf@ggzcentraal.nl

Sponsors and Collaborators
GGZ Centraal
VU University Medical Center
GGZ inGeest
PsyQ
Radboud University
Investigators
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Principal Investigator: Henny Visser, PhD GGZ Centraal

Publications:
Boedhoe PS, Schmaal L, Abe Y, Ameis SH, Arnold PD, Batistuzzo MC, Benedetti F, Beucke JC, Bollettini I, Bose A, Brem S, Calvo A, Cheng Y, Cho KI, Dallaspezia S, Denys D, Fitzgerald KD, Fouche JP, Giménez M, Gruner P, Hanna GL, Hibar DP, Hoexter MQ, Hu H, Huyser C, Ikari K, Jahanshad N, Kathmann N, Kaufmann C, Koch K, Kwon JS, Lazaro L, Liu Y, Lochner C, Marsh R, Martínez-Zalacaín I, Mataix-Cols D, Menchón JM, Minuzzi L, Nakamae T, Nakao T, Narayanaswamy JC, Piras F, Piras F, Pittenger C, Reddy YC, Sato JR, Simpson HB, Soreni N, Soriano-Mas C, Spalletta G, Stevens MC, Szeszko PR, Tolin DF, Venkatasubramanian G, Walitza S, Wang Z, van Wingen GA, Xu J, Xu X, Yun JY, Zhao Q; ENIGMA OCD Working Group, Thompson PM, Stein DJ, van den Heuvel OA. Distinct Subcortical Volume Alterations in Pediatric and Adult OCD: A Worldwide Meta- and Mega-Analysis. Am J Psychiatry. 2017 Jan 1;174(1):60-69. doi: 10.1176/appi.ajp.2016.16020201. Epub 2016 Sep 9. Erratum in: Am J Psychiatry. 2016 Oct 1;173(10 ):1049. Am J Psychiatry. 2017 Feb 1;174(2):190.

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Responsible Party: GGZ Centraal
ClinicalTrials.gov Identifier: NCT03929081     History of Changes
Other Study ID Numbers: NL66299.029.18
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GGZ Centraal:
Obsessive-Compulsive Disorder
Inference Based Approach (IBA)
Cognitive Behavioral Therapy (CBT)
Personalized care
Neurocognitive working mechanisms of treatment
Non-inferiority
Prediction of treatment efficiency

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders