Metacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial|
|- candidate number||20745|
|- NTR Number||NTR4855|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-okt-2014|
|- Secondary IDs||NL50201.058.14 METC|
|- Public Title||Metacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial|
|- Scientific Title||Metacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial|
|- hypothesis||MCT is more effective than ERP, both statistically significant and clinically relevant.|
|- Healt Condition(s) or Problem(s) studied||Obsessive-compulsive disorder (OCD)|
|- Inclusion criteria||Inclusion criteria are: |
1) primary diagnosis of OCD
2) age 18-65.
|- Exclusion criteria||Patients 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 received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-apr-2017|
|- Target number of participants||100|
|- Interventions||Patients 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
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 outcome||Treatment 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
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) and the Thought Fusion Instrument (TFI; Wells et al., 2001) will be employed.
|- Secondary outcome||In 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
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,
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.
|- Timepoints||We 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|
|- CONTACT FOR PUBLIC QUERIES||Dr. C. Heiden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C. Heiden, van der|
|- Sponsor/Initiator ||PsyQ Rijnmond|
(Source(s) of Monetary or Material Support)
|- Brief summary||Obsessive-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|
|- RECORD||21-okt-2014 - 27-nov-2016|
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