- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02437773
Neurocircuit Mechanisms of OCD Across the Lifespan
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 Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Cognitive Behavioral Therapy - Adolescents
- Behavioral: Stress Management Therapy - Adolescents
- Behavioral: Optional CBT - Adolescents
- Behavioral: Cognitive Behavioral Therapy - Adults
- Behavioral: Stress Management Therapy - Adults
- Behavioral: Optional CBT - Adults
- Other: fMRI only - Healthy Control Adolescents
- Other: fMRI only - Healthy Control Adults
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cognitive Behavioral Therapy - Adolescents
12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.
|
A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
Other Names:
|
Other: Stress Management Therapy - Adolescents
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). |
An active control therapy with minimal effects on OCD symptoms.
Other Names:
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Other Names:
|
Active Comparator: Cognitive Behavioral Therapy - Adults
12 CBT sessions scheduled weekly over a 12-week period.
|
A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
Other Names:
|
Other: Stress Management Therapy - Adults
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). |
An active control therapy with minimal effects on OCD symptoms.
Other Names:
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Other Names:
|
Other: Healthy Control - Adolescents
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).
|
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.
|
Other: Healthy Control - Adults
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).
|
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: Optional CBT - Adolescents
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.
|
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Other Names:
|
Other: Optional CBT - Adults
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.
|
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans
Time Frame: Baseline to 12-weeks
|
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 trials based on average signal in a priori defined regions of interest for pMFC, vmPFC and aIns.
The investigators are looking for increases in pMFC activation in adolescents from pre- to post-treatment.
In contrast, the investigators are looking for increases in inverse connectivity (resting state and during task) between vmPFC and aIns in adults from pre- to post-treatment.
|
Baseline to 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 to 40, with 40 being most severe.
The investigators are looking for decreases in OCD severity ratings from pre- to post-treatment.
|
Baseline to 12-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate Fitzgerald, MD, University of Michigan, Dept of Psychiatry
Publications and helpful links
General Publications
- Rueppel M, Mannella KA, Fitzgerald KD, Schroder HS. Post-error slowing in anxiety and obsessive-compulsive disorders. Cogn Affect Behav Neurosci. 2022 Jun;22(3):610-624. doi: 10.3758/s13415-021-00976-9. Epub 2021 Dec 29.
- Norman LJ, Mannella KA, Yang H, Angstadt M, Abelson JL, Himle JA, Fitzgerald KD, Taylor SF. Treatment-Specific Associations Between Brain Activation and Symptom Reduction in OCD Following CBT: A Randomized fMRI Trial. Am J Psychiatry. 2021 Jan 1;178(1):39-47. doi: 10.1176/appi.ajp.2020.19080886. Epub 2020 Aug 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00091368
- R01MH102242-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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