An interventional study of Behavior Therapy in Obsessive Compulsive Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to find out more about how the brain stores emotional learning in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human beings learn not to fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. We hope this study will help us understand why people with OCD cannot control unwanted fear and to develop better treatments for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive 12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking individuals 18-60 with OCD and individuals with no psychiatric history. Participation includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist followed by BT, questionnaires, and up to six (6) MRI scans. You may receive up to $500 for your participation and reimbursement for parking.
The purpose of this study is to find out more about how the brain forms and stores emotional learning. Emotional learning refers to our ability to form an association between sounds or places with emotional events. In particular, we would like to understand how human beings learn not to fear and whether individuals with OCD use certain areas of the brain differently than control individuals. We hope this study will help us understand why people with OCD cannot control unwanted fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. Patients in this study will have an equal chance of undergoing 12 weeks of BT immediately or being placed on a 12-week "waitlist," and then partaking in BT. They will be asked to participate in tasks while in an MRI that takes pictures of the brain. This study will also use mild, half-second electric shocks to fingers. The electric current will be generated from a 9V battery (e.g., battery in a smoke alarm). In order to set the level of the current to be used during the study, we will begin at a level below what patients will be able to feel, and then increase in gradual steps with permission. Patients will be asked to stop the increase at a level of the current that they find highly annoying but not painful. The level of current that patients select during this trial procedure, and no higher level, will be used during the study so that they will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. Patients will receive no more than ten of these electric shocks.
If patients are assigned to immediate BT, participation in this study includes about 20-22 visits to our two clinics at MGH and the Charlestown Navy Yard over the span of 6 months. This includes an initial assessment visit (2.5-3 hours), 12 therapy visits (each session lasting 60-90 minutes long), and 1 booster session at the MGH OCD and Related Disorders Clinic. During the course of therapy, patients will receive weekly practice work between sessions, which should take around 30 minutes to an hour each day to complete. Additionally, patients will participate in 3 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during baseline visit, 2 scans over a two-day period during week 4 visit, and 2 scans over a two-day period during 3-month follow-up (week 24) appointment.
If patients are assigned to the 12-week waiting period before starting BT, participation will include about 21 visits to our clinics, including an initial assessment visit (2.5-3 hours), 12 therapy visits (after the waiting period ends), and 1 booster session at the MGH OCD and Related Disorders Clinic. Patients will be asked to come to the clinic for assessments during weeks 4 and 6 and after the waiting period (week 12). Patients will also participate in 2 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during baseline visit and 2 scans over a two-day period during week 4 visit. Patients may NOT begin any new therapy or medication while on the waiting list.
367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's enrollment of 54 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.
Browse Compulsive Personality Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
If assigned to the immediate BT condition, patients will be asked to make about 24 visits to our clinics at MGH, including an initial assessment, 12 therapy visits over 12 weeks, and 1 booster session (Week 16). Patients will be asked to come to the clinic for assessments during weeks 4 and 6 and after the treatment (week 12), as well as 1 follow-up visit (week 24). Additionally, patients will participate in 6 MRI scanning sessions at the Charlestown Navy Yard.
Behavioral: Behavior Therapy
Patients will wait for 12 weeks before starting BT. In this case, they will be asked to make about 21 visits to our clinics, including an initial assessment visit, 12 therapy visits, and 1 booster session. Patients will be asked to come to the clinic for assessments during (weeks 4 and 6) and after the waiting period (week 12). Additionally, patients will participate in 6 MRI scanning sessions at the Charlestown Navy Yard.
Behavioral: Behavior Therapy
BT for OCD focuses primarily on "exposure with response prevention (ERP)." "ERP" involves gradual exposure to anxiety-provoking situations (things or situations that frighten or disturb some people), and will help to prevent compulsions (repetitive behaviors).
Also known as: Exposure and Response Prevention
Obsessive compulsive symptoms as measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
We assesed reduction in OCD symptom severity over a 24 week period. Efficacy was again compared in the follow-up phase of the study in from week 24 to week 36.
Time frame: 24-36 weeks
Fear Conditioning/Extinction Paradigm
Test Paradigm within MRI scanner
Time frame: 24-36 weeks
Skin Conductance
Recording electrodes will be attached to the palm of the subject's left hand to measure Skin Conductance Rate (SCR). SCR will be measured through a 9-mm (sensor diameter) Sensor Medics Ag/AgCl electrodes (safe for use in the magnet environment).
Time frame: 24-36 weeks
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Compulsive Personality Disorder→
Massachusetts General Hospital