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Interpretation Bias as a Mechanism of Treatment Response in OCD

Interpretation Bias as a Mechanism of Treatment Response in OCD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05224414
Enrollment
106
Registered
2022-02-04
Start date
2022-03-30
Completion date
2026-08-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

Brief summary

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.

Interventions

Sessions 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.

BEHAVIORALPsychoeducation

Sessions 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.

Sponsors

Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * 5\) primary diagnosis of OCD (as measured by a score of \>16 on the Y-BOCS and a clinical diagnosis of OCD by their treatment team * 6\) score of \>131 on the Obsessive Beliefs Questionnaire-44 at admission \[which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)\]

Exclusion criteria

* 1\) Currently experiencing acute symptoms of psychosis * 2\) Psychotic disorder diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Change in Average Score on Yale-Brown Obsessive Compulsive ScaleWeeks 0, 4, and 8Interviewer-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.

Secondary

MeasureTime frameDescription
Change in Average Score on Obsessive Beliefs QuestionnaireTime Frame: Weeks 0, 2, 4, and 8Measure 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.

Countries

United States

Contacts

CONTACTMartha Falkenstein, PhD
mfalkenstein@mclean.harvard.edu617-855-4424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026