RECRUITING

Individually Targeted Neuromodulation for Contamination-based OCD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with obsessive-compulsive disorder (OCD) experience a wide array of different types of obsessions and compulsions. However, current treatments for OCD employ a "one size fits all" approach and are used for all patients regardless of symptom type. In this project, the investigators propose to investigate whether a novel method of transcranial magnetic stimulation specifically reduces contamination/washing symptoms - one of the most common types of OCD.

Official Title

Individually Targeted Neuromodulation for Contamination-based Obsessive-compulsive Disorder

Quick Facts

Study Start:2022-07-01

Study Completion:2024-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05048251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. male or female age 18-55 years old 2. DSM-5 diagnosis of OCD as primary presenting disorder 3. CONTAM as the predominant symptom dimension (i.e., Dimension 4 (CONTAM symptoms) is the highest score on the Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS); participants with more than one Dimension as highest score will still be eligible as long as Dimension 4 is one of these) 4. score of ≥ 8 on Dimension 4 of the D-YBOCS 5. taking no psychiatric medications or on a stable dose of an SSRI, clomipramine, SNRI, or second generation antipsychotic for at least 4 weeks prior to enrollment. Use of PRN benzodiazepines will be permitted as long as the dose/usage has not changed significantly leading up to enrollment. No medication changes will be permitted during the study 6. have not initiated a new course of exposure and response prevention (ERP) therapy within 4 weeks of enrollment (ongoing ERP will be permitted if initiated more than 8 weeks before enrollment).	1. positive urine drug screen (other than prescribed benzodiazepines) 2. use of psychiatric medications other than permitted above 3. substance use disorder in the last 3 months (with the exception of nicotine) 4. history of schizophrenia, bipolar disorder, autism, Tourette's syndrome (current and past history of depressive, anxiety, and eating disorders permitted as long as OCD is considered the primary disorder) 5. active suicidal ideation over the week prior to screening (as indicated by answering yes to questions 1 or 2 on the C-SSRS) 6. history of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease 7. pregnancy or lactating 8. contraindication to MRI scanning or TMS

Inclusion Criteria

Exclusion Criteria

1. male or female age 18-55 years old
2. DSM-5 diagnosis of OCD as primary presenting disorder
3. CONTAM as the predominant symptom dimension (i.e., Dimension 4 (CONTAM symptoms) is the highest score on the Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS); participants with more than one Dimension as highest score will still be eligible as long as Dimension 4 is one of these)
4. score of ≥ 8 on Dimension 4 of the D-YBOCS
5. taking no psychiatric medications or on a stable dose of an SSRI, clomipramine, SNRI, or second generation antipsychotic for at least 4 weeks prior to enrollment. Use of PRN benzodiazepines will be permitted as long as the dose/usage has not changed significantly leading up to enrollment. No medication changes will be permitted during the study
6. have not initiated a new course of exposure and response prevention (ERP) therapy within 4 weeks of enrollment (ongoing ERP will be permitted if initiated more than 8 weeks before enrollment).

1. positive urine drug screen (other than prescribed benzodiazepines)
2. use of psychiatric medications other than permitted above
3. substance use disorder in the last 3 months (with the exception of nicotine)
4. history of schizophrenia, bipolar disorder, autism, Tourette's syndrome (current and past history of depressive, anxiety, and eating disorders permitted as long as OCD is considered the primary disorder)
5. active suicidal ideation over the week prior to screening (as indicated by answering yes to questions 1 or 2 on the C-SSRS)
6. history of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease
7. pregnancy or lactating
8. contraindication to MRI scanning or TMS

Contacts and Locations

Study Contact

Rosalind Sokoll

CONTACT

617-855-2911

rsokoll@mgh.harvard.edu

Principal Investigator

Brian P Brennan, MD

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Study Locations (Sites)

McLean Hospital

Belmont, Massachusetts, 02478

United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Brian P Brennan, MD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01

Study Completion Date2024-06-30

Study Record Updates

Study Start Date2022-07-01

Study Completion Date2024-06-30

Terms related to this study

Additional Relevant MeSH Terms

Obsessive-Compulsive Disorder