Neurocircuit Mechanisms of OCD Across the Lifespan
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 13 - 45 |
| Updated: | 1/17/2019 |
| Start Date: | September 2014 |
| End Date: | July 2019 |
| Contact: | Eunice Kim |
| Email: | Psych-OCD-Study@med.umich.edu |
| Phone: | 734-232-0443 |
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.
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.
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.
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.
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
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kate Fitzgerald, MD
Phone: 734-232-0443
University of Michigan The University of Michigan was founded in 1817 as one of the...
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