Pilot: Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

Pilot: Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder

Description

The purpose of this study is to find out more about how the brain forms and stores emotional learning. Emotional learning means 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. If you take part in this research study, you 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. You will be asked to participate in tasks while in an MRI that takes pictures of your brain. This study will also use mild, half-second electric shocks to your 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 you will be able to feel, and then increase in gradual steps with your permission. You will be asked to stop the increase at a level of the current that you find highly annoying but not painful. The level of current that you select during this trial procedure, and no higher level, will be used during the study so that you will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. You will receive no more than ten of these electric shocks.

If you 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 your therapy, you will receive weekly practice work between sessions, which should take you around 30 minutes to an hour each day to complete. Additionally, you will participate in 3 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during your baseline visit, 2 scans over a two-day period during your week 4 visit, and 2 scans over a two-day period during your 3-month follow-up (week 24) appointment.

If you 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. You will be asked to come to the clinic for assessments during weeks 4 and 6 and after the waiting period (week 12). You will also participate in 2 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during your baseline visit and 2 scans over a two-day period during your week 4 visit. You may NOT begin any new therapy or medication while on the waiting list.

You may receive up to $500 for your participation (depending on the number of visits).

Please note that this study involves a 24-36 week participation period, and therapy visits are generally 60-90 minutes long during normal business hours. If you do decide to come in for a baseline visit, your medication must remain constant and you cannot begin any new therapy. You also must be willing to stop any therapy you are already receiving prior to your participation with us.

For more information, please contact Dylan Abrams at 617-643-4387 or dabrams3@mgh.harvard.edu.

Details
Condition Obsessive-Compulsive Disorder
Clinical Study IdentifierTX145174
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

-60 years of age
Proficiency in English and able to give informed consent
For OCD patients only: Primary OCD that causes at least moderate distress and/or impairment (Y-BOCS total score > 16)
Normal (or corrected) vision
Stable medication regimen or medication-free for ≥ 8 weeks

Exclusion Criteria

Weight > 250 lbs
Current clinically significant suicidality and/or BDI-II suicide item (#9) score > 1
History of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) other than OCD, secondary anxiety disorders, or secondary major depression that is non-psychotic
Psychopathology not appropriate for the treatment, such as
Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference
Current manic episode
Psychosis
Previous treatment with ≥4 sessions of BT for OCD or currently in BT or any other psychotherapy; planning to initiate such treatment during the study
Use of conventional antipsychotic medications or medications that would lower seizure threshold in high doses or may otherwise affect cerebral metabolism (other than to those required for stabilization of OCD). Use of other psychotropic medications (e.g., SSRIs and atypical antipsychotics) will be allowed provided the dose has been stable for > 8 weeks prior to study baseline or discontinuation of psychotropic medication has been > than 8 weeks prior to study baseline; Use of benzodiazepines within 2 weeks prior to study
Planning on initiation or dose change of psychotropic medication during the study
Major/chronic medical conditions that would likely interfere with participation
Metal in the body, metal injury to the eyes; Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae, history of seizures, history of stroke, signs of increased intracranial pressure, prior neurological procedure
Pregnancy, breastfeeding, or nursing; if the patient cannot rule out the possibility of pregnancy, a pregnancy test (to be ruled out by urine-βHCG) will be conducted prior to the study
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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