Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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.


Study summary:

While the study itself is of parallel design for its data-collection and measurement purpose, it is listed as a partial-crossover design in the IRB-approved protocol because subjects randomized to the SMT group are given the option of entering 12-weeks of CBT sessions after all of their SMT data collection. To understand brain changes that occur with CBT compared to SMT in both age groups, the investigators will collect fMRI data before and after therapy. Some limited data will be collected in patients who are initially randomized to SMT but then opt to crossover to CBT. fMRI data will also be collected in healthy teens and adults before and after 12 weeks (but without intervening therapy) to allow the investigators to control for the simple effects of time that may cause brain changes that are not related to therapy.


Criteria:

Inclusion Criteria for all OCD Subjects & Healthy Volunteers: - Male or female - Age 13-17 (inclusive) subjects diagnosed with OCD, age of onset before 15 years - Age 25-45 (inclusive) subjects diagnosed with OCD, age of onset before 15 years - Age 13-17 (inclusive) year old healthy volunteers - Age 25-45 (inclusive) year old healthy volunteers - OCD adolescent and adult subjects can be on medications but will have to be on a stable medication regimen for at least 4 weeks prior to enrolling. - Able and willing to give informed consent - Ability to tolerate small, enclosed spaces without anxiety Exclusion Criteria for OCD Subjects: - Anyone between the ages of 18-24 (inclusive range) - No lifetime diagnosis of bipolar or psychosis disorders - Age of OCD onset after 15 years old - No substance/alcohol abuse in the past 6 months - No lifetime history of substance/alcohol dependence - No evidence of suicidal intentions or behaviors in the past 6 months - No history of serious medical or neurological illness - No history of closed head injury (e.g. loss of consciousness) - Pregnant or trying to become pregnant Additional Exclusion Criteria for Healthy Volunteers: - No history of past or current mental illness - Not taking any medication, prescription or non-prescription, with psychotropic effects - First-degree family members with OCD or tic disorders


Study is Available At:


Original ID:

HUM00091368


NCT ID:

NCT02437773


Secondary ID:


Study Acronym:


Brief Title:

Neurocircuit Mechanisms of OCD Across the Lifespan


Official Title:

Neurocircuit Mechanisms of OCD Across the Lifespan


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

13 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

8


Number of Groups:

0


Total Enrollment:

206


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kate Fitzgerald, MD
Principal Investigator
University of Michigan, Dept of Psychiatry

Study Dates

Start Date:September 2014
Completion Date:March 2020
Completion Type:Anticipated
Primary Completion Date:March 2020
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 4, 2019
First Received Date:May 2, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans
Time Frame:Baseline to 12-weeks
Safety Issues:False
Description:fMRI BOLD signal response of posterior medial frontal cortex (pMFC), ventral medial prefrontal cortex (vmPFC) and anterior insula (aIns) during performance monitoring. This signal will be measured as BOLD contrast estimates for errors compared to correct
Outcome Type:Secondary Outcome
Measure:OCD symptom severity measured by the Yale Brown Obsessive Compulsive Scale for adults or the Child Yale Brown Obsessive Compulsive Scale for adolescents.
Time Frame:Baseline to 12-weeks
Safety Issues:False
Description:OCD symptom severity measured by the Yale Brown Obsessive Compulsive Scale for adults and the Child Yale Brown Obsessive Compulsive Scale for adolescents. This scale is administered by an independent assessor to rate OCD symptom severity on a scale of 0 t

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Behavioral Therapy - Adolescents
Description:A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
Arm Name:Cognitive Behavioral Therapy - Adolescents
Other Name:CBT
Intervention Type:Behavioral
Name:Stress Management Therapy - Adolescents
Description:An active control therapy with minimal effects on OCD symptoms.
Arm Name:Stress Management Therapy - Adolescents
Other Name:SMT
Intervention Type:Behavioral
Name:Optional CBT - Adolescents
Description:This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Arm Name:Stress Management Therapy - Adolescents
Other Name:CBT
Intervention Type:Behavioral
Name:Cognitive Behavioral Therapy - Adults
Description:A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
Arm Name:Cognitive Behavioral Therapy - Adults
Other Name:CBT
Intervention Type:Behavioral
Name:Stress Management Therapy - Adults
Description:An active control therapy with minimal effects on OCD symptoms.
Arm Name:Stress Management Therapy - Adults
Other Name:SMT
Intervention Type:Behavioral
Name:Optional CBT - Adults
Description:This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Arm Name:Stress Management Therapy - Adults
Other Name:CBT
Intervention Type:Other
Name:fMRI only - Healthy Control Adults
Description: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.
Arm Name:Healthy Control - Adults
Intervention Type:Other
Name:fMRI only - Healthy Control Adolescents
Description: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.
Arm Name:Healthy Control - Adolescents

Study Arms

Study Arm Type:Active Comparator
Arm Name:Cognitive Behavioral Therapy - Adolescents
Description:12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.
Study Arm Type:Other
Arm Name:Stress Management Therapy - Adolescents
Description:12 SMT sessions scheduled weekly over a 12-week period. After study completion, the OCD subjects who received SMT may derive benefit for non-OCD anxiety symptoms. They will be offered a 12-week course of CBT with a study therapist to directly target OCD symptoms (i.e., a partial cross-over).
Study Arm Type:Active Comparator
Arm Name:Cognitive Behavioral Therapy - Adults
Description:12 CBT sessions scheduled weekly over a 12-week period.
Study Arm Type:Other
Arm Name:Stress Management Therapy - Adults
Description:12 SMT sessions scheduled weekly over a 12-week period. After study completion, the OCD subjects who received SMT may derive benefit for non-OCD anxiety symptoms. They will be offered a 12-week course of CBT with a study therapist to directly target OCD symptoms (i.e., a partial cross-over).
Study Arm Type:Other
Arm Name:Healthy Control - Adolescents
Description:Healthy control adolescents matched to gender, race and socioeconomic status (SES) with adolescent patients with OCD will be enrolled. These healthy adolescents will be scanned with fMRI before and after 12 weeks, but without any intervention (i.e., no therapy).
Study Arm Type:Other
Arm Name:Healthy Control - Adults
Description:Healthy control adults matched to gender, race and socioeconomic status (SES) with adult patients with OCD will be enrolled. These healthy adults will be scanned with fMRI before and after 12 weeks, but without any intervention (i.e., no therapy).
Study Arm Type:Other
Arm Name:Optional CBT - Adolescents
Description:OCD adolescent participants who were randomized to the SMT and have completed all study procedures will be offered an additional 12 weeks of Optional Cognitive-Behavioral Therapy.
Study Arm Type:Other
Arm Name:Optional CBT - Adults
Description:OCD adult participants who were randomized to the SMT and have completed all study procedures will be offered an additional 12 weeks of Optional Cognitive-Behavioral Therapy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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