Neurocircuit Mechanisms of OCD Across the Lifespan

NCT02437773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2020-11-06

No results posted yet for this study

Summary

Obsessive-compulsive disorder (OCD), characterized by intrusive thoughts (obsessions) and related behavioral rituals (compulsions), is a common psychiatric illness that often emerges in childhood and causes life-long disability in over 50% of patients. Psychological theory suggests that OCD symptoms are driven by a person's difficulty disengaging their feelings from simple tasks (e.g. washing hands, locking a door) due to excessive anxiety about performance errors. Cognitive behavioral therapy (CBT), the gold standard treatment for OCD, repeatedly exposes patients to their OCD-stressor until this anxiety is reduced. While CBT is typically more effective in teenagers than adults, patients from both age groups are usually left with residual symptoms, highlighting the need for better treatments. In this study, CBT will be studied in both teen-aged and adult patients. Two groups, both with childhood onset OCD, will be randomized to either CBT for OCD or stress management training (SMT), an active therapy but with minimal effects on OCD symptoms. The investigators will also study age-matched, healthy controls as comparison subjects.

Before and after 12 weeks of CBT, all subjects will undergo functional Magnetic Resonance Imaging (fMRI) scans to see what regions of the brain become active when a concentration task is performed and how that activation is changed after CBT. The purpose of this study is to demonstrate the brain changes associated with CBT treatment and how differences in these changes in teenage compared to adult patients may drive differences in CBT response.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy - Adolescents

A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.

BEHAVIORAL

Stress Management Therapy - Adolescents

An active control therapy with minimal effects on OCD symptoms.

BEHAVIORAL

Optional CBT - Adolescents

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

BEHAVIORAL

Cognitive Behavioral Therapy - Adults

A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.

BEHAVIORAL

Stress Management Therapy - Adults

An active control therapy with minimal effects on OCD symptoms.

BEHAVIORAL

Optional CBT - Adults

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

OTHER

fMRI only - Healthy Control Adults

Two fMRI's only, scheduled at 12-weeks apart. This is for Healthy Control Adults and is used only as a means for observation, NOT as an intervention to be studied.

OTHER

fMRI only - Healthy Control Adolescents

Two fMRI's only, scheduled at 12-weeks apart. This is for Healthy Control Adolescents and is used only as a means for observation, NOT as an intervention to be studied.

Sponsors & Collaborators

Principal Investigators

  • Kate Fitzgerald, MD · University of Michigan, Dept of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-09
Primary Completion
2020-04-13
Completion
2020-10-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02437773 on ClinicalTrials.gov