[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05224414":3,"trial-entities:NCT05224414":88,"trial-summary:NCT05224414":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":49,"minimum_age":50,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":63,"locations":66,"central_contacts":82,"overall_officials":85,"references":86,"see_also_links":87},"NCT05224414","2022P000190","Interpretation Bias as a Mechanism of Treatment Response in OCD","RECRUITING","2026-08-31","2026-05","2026-05-18","2022-03-30","Mclean Hospital","OTHER",false,"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.\n\nAdults 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.",null,[18],"Obsessive-Compulsive Disorder",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},106,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Cognitive bias modification for interpretation bias","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.",[33],"Cognitive bias modification with treatment as usual",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Psychoeducation","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.",[38],"Psychoeducation with treatment as usual",[40],{"measure":41,"description":42,"timeFrame":43},"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.","Weeks 0, 4, and 8",[45],{"measure":46,"description":47,"timeFrame":48},"Change in Average Score on Obsessive Beliefs Questionnaire","Measure of interpretation biases, specifically: Inflated Responsibility\u002FOverestimation of Threat, Perfectionism\u002FIntolerance of Uncertainty, and Importance\u002FControl of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity.","Time Frame: Weeks 0, 2, 4, and 8","ALL","18 Years",{"inclusion":52,"exclusion":59,"raw_text":62},[53,54,55,56,57,58],"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)\\]",[60,61],"1\\) Currently experiencing acute symptoms of psychosis","2\\) Psychotic disorder diagnosis","Inclusion Criteria:\n\n* 1\\) OCD Institute patients\n* 2\\) adults (\\> 18 years old)\n* 3\\) able to complete a computer task for 20 minutes\n* 4\\) consent to main OCD Institute study protocol\n* 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\n* 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)\\]\n\nExclusion Criteria:\n\n* 1\\) Currently experiencing acute symptoms of psychosis\n* 2\\) Psychotic disorder diagnosis",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"status":7,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"McLean Hospital","Belmont","Massachusetts","02478","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Martha Falkenstein","CONTACT","617-855-4424","mfalkenstein@mclean.harvard.edu",{"lat":80,"lon":81},42.39593,-71.17867,[83],{"name":84,"role":76,"phone":77,"email":78},"Martha Falkenstein, PhD",[],[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Obsessive Compulsive Disorder",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is a randomized controlled trial with 106 planned participants. You would be randomly assigned to one of two groups.","completed","OCD Treatment with Cognitive Bias Modification","This study is looking at a new approach called Cognitive Bias Modification for Interpretation (CBM-I) for adults with Obsessive-Compulsive Disorder (OCD). CBM-I is a digital program that helps change how people interpret ambiguous situations, aiming to reduce biased thinking often seen in anxiety. You would be recruited from an OCD treatment program and randomly assigned to either receive up to 12 sessions of CBM-I or up to 12 sessions of psychoeducation (education about anxiety and treatments). The researchers want to see if CBM-I is practical, acceptable, and helps improve OCD symptoms, measured by changes in your Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score over 8 weeks. To join, you need to be an adult patient at the OCD Institute with a primary OCD diagnosis and be able to complete a 20-minute computer task.","Your progress will be followed for 8 weeks after the start of the study.",132,"You would participate in up to 12 sessions of either CBM-I or psychoeducation. Your OCD symptoms would be measured at the start, at 4 weeks, and at 8 weeks.","Not stated in the trial record.",[35],"v2"]