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…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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 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) 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 (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.
Background 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.
Study objective
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.
Study design
We will conduct a randomized controlled trial (RCT) with a
pretest-posttest-6-month-30-month-follow-up-design, with two treatment
conditions. Both manual-driven treatments consist of 15 weekly sessions. To
achieve a power of 0.80 (α = 0.05) to detect a medium difference (effect size
0.5) the minimum sample size necessary in each condition is 45.
Intervention
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 patients* beliefs
about thoughts and thought processes, with the aim to alter the patients*
relationship with their thoughts as opposed to challenging the actual content
of thoughts (as is done in CT).
Study burden and risks
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.
Max Euwelaan 60-80
Rotterdam 3062 MA
NL
Max Euwelaan 60-80
Rotterdam 3062 MA
NL
Listed location countries
Age
Inclusion criteria
Primary diagnosis of obsessive-compulsive disorder, age between 18-65
Exclusion criteria
To enhance the clinical representativeness of the sample, exclusion criteria will be kept to a minimum. Patients are only excluded if they currently:
1) meet DSM-V criteria for severe major depressive disorder that requires immediate treatment, psychotic disorder, or bipolar disorder
2) have mental impairment or evidence of organic brain disorder
3) have substance abuse requiring specialist treatment
4) have a change in medication type or dose in the six weeks before assessment or during treatment.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50201.058.14 |
| OMON | NL-OMON22167 |