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Trial record 2 of 17 for:    sabine wilhelm

Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Sabine Wilhelm, Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02467374
First received: June 1, 2015
Last updated: May 24, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Obsessive Compulsive Disorder Behavioral: Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Pilot: Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Sabine Wilhelm, Massachusetts General Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 24-36 weeks ]

Other Outcome Measures:
  • Fear Conditioning/Extinction Paradigm [ Time Frame: 24-36 weeks ]
    Test Paradigm within MRI scanner

  • Skin Conductance [ Time Frame: 24-36 weeks ]
    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).


Estimated Enrollment: 40
Study Start Date: December 2014
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate Behavior Therapy
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
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 Name: Exposure and Response Prevention
Active Comparator: Waitlist 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).
Other Name: Exposure and Response Prevention

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Outpatient men and women age 18 to 60, proficient 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)

Exclusion Criteria:

  • Current clinically significant suicidality and/or BDI-II suicide item (#9) score >1
  • Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in BT
  • Psychopathology not appropriate for the treatment (such as substance abuse or dependence within the past 3 months; current manic episode; psychosis)
  • Previous treatment with ≥4 sessions of BT for OCD
  • Currently receiving any other psychotherapy or 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 benzodiazepines within 2 weeks prior to study is not allowed. Use of other psychotropic medications (e.g., SSRIs and atypical antipsychotics) will be allowed provided the dose has been stable for > 8 weeks. Planning on initiation or dose change of psychotropic medication during the study.
  • Impaired (or uncorrected) vision, medical illness, or medical treatment that would likely interfere with participation.
  • 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 neurosurgical procedure
  • Metal in the body, metal injury to the eyes; Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
  • Pregnancy; breastfeeding or nursing; if the patient cannot rule out the possibility of pregnancy, a pregnancy test (to be ruled out by urine ß-HCG) will be conducted prior to study
  • Weight > 250 lbs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02467374

Contacts
Contact: Dylan Abrams, BA 617-643-4387 dabrams3@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dylan Abrams, BA    617-643-4387    dabrams3@mgh.harvard.edu   
Contact: Barbara Rosemberg, MHA    617-643-3079    brosemberg@mgh.harvard.edu   
Sub-Investigator: Jennifer L Greenberg, Psy. D.         
Principal Investigator: Sabine Wilhelm, Ph. D.         
Principal Investigator: Mohammed Milad, Ph. D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital: Department of Psychiatry
Principal Investigator: Mohammed Milad, Ph.D. Massachusetts General Hospital: Department of Psychiatry
  More Information

Responsible Party: Sabine Wilhelm, Sabine Wilhelm, PhD, Chief of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02467374     History of Changes
Other Study ID Numbers: 2014P002325
Study First Received: June 1, 2015
Last Updated: May 24, 2017

Keywords provided by Sabine Wilhelm, Massachusetts General Hospital:
OCD
Neuroimaging
Fear Extinction
Behavior Therapy

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior

ClinicalTrials.gov processed this record on June 23, 2017