An interventional study of Cognitive Behavioral Therapy - Adolescents and Stress Management Therapy - Adolescents in Obsessive-Compulsive Disorder, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 13 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.
This study's enrollment of 206 is above the median of 45 across 492 interventional studies indexed under Obsessive-Compulsive Disorder.
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Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Inclusion Criteria for all OCD Subjects \& Healthy Volunteers:
Exclusion Criteria for OCD Subjects:
Additional Exclusion Criteria for Healthy Volunteers:
12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.
Behavioral: Cognitive Behavioral 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).
Behavioral: Stress Management Therapy - Adolescents · Behavioral: Optional CBT - Adolescents
12 CBT sessions scheduled weekly over a 12-week period.
Behavioral: Cognitive Behavioral 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).
Behavioral: Stress Management Therapy - Adults · Behavioral: Optional CBT - Adults
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).
Other: fMRI only - Healthy Control Adolescents
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).
Other: fMRI only - Healthy Control Adults
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.
Behavioral: Optional CBT - Adolescents
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.
Behavioral: Optional CBT - Adults
A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
Also known as: CBT
An active control therapy with minimal effects on OCD symptoms.
Also known as: SMT
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Also known as: 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.
Also known as: CBT
An active control therapy with minimal effects on OCD symptoms.
Also known as: SMT
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Also known as: 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.
Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans
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 or the Child Yale Brown Obsessive Compulsive Scale for adolescents.
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.
Time frame: Baseline to 12-weeks
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder→
University of Michigan