Clinical trial NCT03799419: Cognitive Bias Modification for OCD
Official title: Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Obsessive-compulsive Disorders and Symptoms
Keywords: cognitive bias modification
interpretation bias
approach avoidance
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.

Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.


Eligibility criteria: Inclusion Criteria:

* Currently receiving treatment at the McLean Hospital OCD Institute
* For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute
* For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute
* Able to complete a computer task for 20 minutes
* Consent to main OCD Institute study protocol

Exclusion Criteria:

* Currently undergoing electroconvulsive therapy (ECT)
* Current symptoms of acute mania or psychosis
* A reported diagnosis at admission of a psychotic disorder
* History of traumatic brain injury

Primary outcomes:
measure: Change in Average Score on Obsessive Beliefs Questionnaire
timeFrame: Weeks 0, 2, 4, and 8
Secondary outcomes:
measure: Change in Average Score on Yale-Brown Obsessive Compulsive Scale
timeFrame: Weeks 0, 4, and 8
measure: Change in Columbia-Suicide Severity Rating Scale
timeFrame: Weeks 0, 4, and 8
measure: Change in Suicide Implicit Association Test
timeFrame: Weeks 0, 2, and 4
measure: Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.
timeFrame: Weeks 0, 1, 2, 3, and 4
measure: Credibility/Expectancy Questionnaire
timeFrame: Week 0
measure: Exit Interview
timeFrame: Week 4
measure: Change in Behavioral Approach Test
timeFrame: Weeks 0, 2, and 4
measure: Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales
timeFrame: Weeks 0, 2, 4, and 8
measure: Dimensional Obsessive-Compulsive Scale
timeFrame: Weeks 0, 2, 4, and 8
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References: