Interpretation Bias as a Mechanism of Treatment Response in OCD
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMclean Hospital
About this trial
This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.
Adults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1) OCD Institute patients
2) adults (> 18 years old)
3) able to complete a computer task for 20 minutes
4) consent to main OCD Institute study protocol
Disqualifiers
1) Currently experiencing acute symptoms of psychosis
2) Psychotic disorder diagnosis
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive bias modification for interpretation bias
BehavioralSessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity.
Psychoeducation
BehavioralSessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Cognitive bias modification with treatment as usualExperimental treatment 1 intervention
Group B: Psychoeducation with treatment as usualSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Average Score on Yale-Brown Obsessive Compulsive Scale
Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity.
Time frame
Weeks 0, 4, and 8Secondary outcomes
1
Change in Average Score on Obsessive Beliefs Questionnaire
Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity.
Time frame
Time Frame: Weeks 0, 2, 4, and 8Sponsors and contacts
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Source ClinicalTrials.gov