University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT02437773
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.
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Notify Me13 year–45 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for all OCD Subjects & Healthy Volunteers:
Exclusion criteria
for OCD Subjects:
Additional Exclusion Criteria for Healthy Volunteers:
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: CBT
An active control therapy with minimal effects on OCD symptoms.
Other names: SMT
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Other names: CBT
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: CBT
An active control therapy with minimal effects on OCD symptoms.
Other names: SMT
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Other names: CBT
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.
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.
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.
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.
University of Michigan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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