Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): 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).
Other intervention name(s): Exposure and Response Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; Neuroimaging; Fear Extinction; Behavior Therapy