Neurocircuit Mechanisms of OCD Across the Lifespan

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy - Adolescents; Behavioral: Stress Management Therapy - Adults; Behavioral: Optional CBT - Adolescents; Behavioral: Cognitive Behavioral Therapy - Adults; Other: fMRI only - Healthy Control Adults; Other: fMRI only - Healthy Control Adolescents; Behavioral: Stress Management Therapy - Adolescents; Behavioral: Optional CBT - Adults

• Registration Number: NCT02437773
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03-09
• Study First Submitted: 2015-05-02
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Primary Completion: 2020-04-13
• Study Completion: 2020-10-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy - Adolescents	Cognitive Behavioral Therapy - Adolescents	12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.
Stress Management Therapy - Adults	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).
Optional CBT - Adolescents	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.
Cognitive Behavioral Therapy - Adults	Cognitive Behavioral Therapy - Adults	12 CBT sessions scheduled weekly over a 12-week period.
Stress Management Therapy - Adults	Optional CBT - 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).
Healthy Control - Adults	fMRI only - 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).
Stress Management Therapy - Adolescents	Optional CBT - 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).
Healthy Control - Adolescents	fMRI only - 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).
Stress Management Therapy - Adolescents	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).
Optional CBT - Adults	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.

Primary Outcome Measures

Name	Time	Method
Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans	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.

Secondary Outcome Measures

Name	Time	Method
OCD symptom severity measured by the Yale Brown Obsessive Compulsive Scale for adults or the Child Yale Brown Obsessive Compulsive Scale for adolescents.	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States