Neurocircuit Mechanisms of OCD Across the Lifespan
2 other identifiers
interventional
206
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2015
CompletedFirst Submitted
Initial submission to the registry
May 2, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2020
CompletedNovember 6, 2020
November 1, 2020
5.1 years
May 2, 2015
November 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 12-weeks
Secondary Outcomes (1)
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
Study Arms (8)
Cognitive Behavioral Therapy - Adolescents
ACTIVE COMPARATOR12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.
Stress Management Therapy - Adolescents
OTHER12 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).
Cognitive Behavioral Therapy - Adults
ACTIVE COMPARATOR12 CBT sessions scheduled weekly over a 12-week period.
Stress Management Therapy - Adults
OTHER12 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
OTHERHealthy 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).
Healthy Control - Adults
OTHERHealthy 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).
Optional CBT - Adolescents
OTHEROCD 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.
Optional CBT - Adults
OTHEROCD 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.
Interventions
A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
An active control therapy with minimal effects on OCD symptoms.
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
An active control therapy with minimal effects on OCD symptoms.
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (3)
Himle JA, Grogan-Kaylor A, Hiller MA, Mannella KA, Norman LJ, Abelson JL, Prout A, Shunnarah AA, Becker HC, Russman Block SR, Taylor SF, Fitzgerald KD. Exposure and response prevention versus stress management training for adults and adolescents with obsessive compulsive disorder: A randomized clinical trial. Behav Res Ther. 2024 Jan;172:104458. doi: 10.1016/j.brat.2023.104458. Epub 2023 Dec 12.
PMID: 38103359DERIVEDRueppel 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.
PMID: 34966981DERIVEDNorman 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.
PMID: 32854533DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Fitzgerald, MD
University of Michigan, Dept of Psychiatry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Psychiatry, University of Michigan
Study Record Dates
First Submitted
May 2, 2015
First Posted
May 8, 2015
Study Start
March 9, 2015
Primary Completion
April 13, 2020
Study Completion
October 21, 2020
Last Updated
November 6, 2020
Record last verified: 2020-11