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van CCT (UK)

van CCT (UK)

Metacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial

- candidate number20745
- NTR NumberNTR4855
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2014
- Secondary IDsNL50201.058.14  METC
- Public TitleMetacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial
- Scientific TitleMetacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial
- hypothesisMCT is more effective than ERP, both statistically significant and clinically relevant.
- Healt Condition(s) or Problem(s) studiedObsessive-compulsive disorder (OCD)
- Inclusion criteriaInclusion criteria are:
1) primary diagnosis of OCD
2) age 18-65.
- Exclusion criteriaPatients are only excluded if they currently:
1) meet DSM-IV-TR criteria for severe major depressive disorder that requires immediate treatment, psychotic disorder, or bipolar disorder,
2) have substance abuse requiring specialist treatment, or
3) have a change in psychiatric medication type or dose in the six weeks before assessment or during treatment.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate31-dec-2019
- Target number of participants100
- InterventionsPatients will be randomly assigned to metacognitive therapy or exposure and responsprevention. The interventions will be offered at the Anxiety Disorders Department of PsyQ (Rotterdam and Spijkenisse). Both manual-driven treatments consist of 15 weekly sessions of 45 minutes duration.

Exposure with responsprevention consists of (1) exposure to the anxiety provoking stimuli and (2) prevention of neutralizing responses that reduce anxiety.
Metacognition refers to knowledge or beliefs about thinking and strategies used to regulate and control thinking processes.

The metacognitive model of OCD specifies two subcategories of beliefs that are fundamental to the maintenance of the disorder; (1) metacognitive beliefs about the meaning and consequences of intrusive thoughts and feelings, and (2) beliefs about the necessity of performing rituals and the negative consequences of failing to do so.
Resulting from the metacognitive model, treatment focuses on modifying patientsí beliefs about thoughts and thought processes, with the aim to alter the patientsí relationship with their thoughts as opposed to challenging the actual content of thoughts (as is done in CT).
- Primary outcomeTreatment outcome will be evaluated by means of the Dutch versions of both a standardized self-report scale (Padua Inventory; Burns et al., 1996) and a semi-structured interview (Yale-Brown Obsessive Compulsive Scale [Y-BOCS]; Goodman et al., 1989) for measuring the core symptoms of OCD (primary outcomes). Additionally, we will do a SCID-I screening.

To study changes in both belief domains that have been proposed to be important in the etiology of OCD and metacognitive beliefs about the meaning, significance, and danger of intrusive thoughts, the Obsessive Beliefs Questionnaire-44 (OBQ-44; OCCWG, 2005), the Thought Fusion Instrument (TFI; Wells et al., 2001) and the Beliefs About Rituals Inventory (BARI; Adrian Wells & Kirsten McNicol, 2012) will be employed.
- Secondary outcomeIn addition of the primary study parameters, questionnaires of general psychopathology (Symptom Checklist [SCL-90]; Derogatis, 1983), depression (Beck Depression Inventory, 2nd version [BDI-II]; Beck et al., 1996), and quality of life (WHOQOL-Bref; WHO, 2004) will be administered to assess comorbid symptoms and degree of perceived well-being (secondary outcomes).
At entry also three additional measurements will be employed in order to describe the participants characteristics at baseline (intolerance of uncertainty scale [IUS]; Freeston, Rheaume, Letarte, Dugas, & Ladouceur, 1994; NEO Five Factor Index [NEO-FFI]; Costa & mcCrae, 1992; Anxiety Sensitivity Index [ASI]; Reiss, Peterson, Gursky, & McNally, 1986).
Additionally, on both follow-up assessments, participants will be called by a member of the research team, who will ask them to provide responses for the Treatment Change Recording Form (TCRF; Tolin et al., 2004), which will be used to assess the initiation, termination, or change of any form of therapy, hospital services, support group, self-help program, or medication utilized by the participant since posttreatment.
- TimepointsWe will conduct a randomized controlled trial (RCT) with a pretest-posttest-6-month-30-month-follow-up-design.

Estimated time to fill in the questionnaires will take about 360 minutes per participant at max. (4 times 90 minutes)
Participation at the telephonic interview will take 20 minutes per participant at max. (2 times 10 minutes).
Their are no risks for the participants.
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESDr. C. Heiden, van der
- Sponsor/Initiator PsyQ Rijnmond
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryObsessive-compulsive disorder (OCD) is characterized by recurrent obsessions and/or compulsions that cause marked distress and interfere with daily functioning. Exposure with responsprevention is the current treatment of choice for OCD. However, ERP for OCD is a good example of the discrepancy between statistically and clinically significant change. Although several studies and meta-analyses have shown ERP to lead to statistically significant improvements and large effect sizes, only about 60% of treatment completers achieve recovery. These data show that there is room for improvement and a need for augmentation of current CBT strategies. It has been suggested that progress might be made by basing treatments on key cognitive processes involved in the development and maintenance of the disorder, such as metacognition. So far, two studies have provided support for the efficacy of MCT for OCD.

The present trial is initiated to compare the effectiveness of MCT with ERP, the current treatment of choice for OCD, in an outpatient clinical sample of patients with OCD. The following hypothesis is formulated: MCT is more effective than ERP, both statistically significant and clinically relevant.
- Main changes (audit trail)27-nov-2016: New power calculation: participants inclusion 100
- RECORD21-okt-2014 - 20-aug-2018

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