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Neurocircuit Mechanisms of OCD Across the Lifespan

NCT ID: NCT02437773

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-09

Study Completion Date

2020-10-21

Brief Summary

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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

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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.

Conditions

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Obsessive-Compulsive Disorder

Keywords

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OCD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Cognitive Behavioral Therapy - Adolescents

12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy - Adolescents

Intervention Type BEHAVIORAL

A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.

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).

Group Type OTHER

Stress Management Therapy - Adolescents

Intervention Type BEHAVIORAL

An active control therapy with minimal effects on OCD symptoms.

Optional CBT - Adolescents

Intervention Type BEHAVIORAL

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

Cognitive Behavioral Therapy - Adults

12 CBT sessions scheduled weekly over a 12-week period.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy - Adults

Intervention Type BEHAVIORAL

A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.

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).

Group Type OTHER

Stress Management Therapy - Adults

Intervention Type BEHAVIORAL

An active control therapy with minimal effects on OCD symptoms.

Optional CBT - Adults

Intervention Type BEHAVIORAL

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

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).

Group Type OTHER

fMRI only - Healthy Control Adolescents

Intervention Type OTHER

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.

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).

Group Type OTHER

fMRI only - Healthy Control Adults

Intervention Type OTHER

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.

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.

Group Type OTHER

Optional CBT - Adolescents

Intervention Type BEHAVIORAL

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

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.

Group Type OTHER

Optional CBT - Adults

Intervention Type BEHAVIORAL

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

Interventions

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Cognitive Behavioral Therapy - Adolescents

A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.

Intervention Type BEHAVIORAL

Stress Management Therapy - Adolescents

An active control therapy with minimal effects on OCD symptoms.

Intervention Type BEHAVIORAL

Optional CBT - Adolescents

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy - Adults

A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.

Intervention Type BEHAVIORAL

Stress Management Therapy - Adults

An active control therapy with minimal effects on OCD symptoms.

Intervention Type BEHAVIORAL

Optional CBT - Adults

This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.

Intervention Type BEHAVIORAL

fMRI only - Healthy Control Adults

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.

Intervention Type OTHER

fMRI only - Healthy Control Adolescents

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.

Intervention Type OTHER

Other Intervention Names

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CBT SMT CBT CBT SMT CBT

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kate D. Fitzgerald

Associate Professor, Department of Psychiatry, University of Michigan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Dept of Psychiatry

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38103359 (View on PubMed)

Rueppel 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.

Reference Type DERIVED
PMID: 34966981 (View on PubMed)

Norman 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.

Reference Type DERIVED
PMID: 32854533 (View on PubMed)

Other Identifiers

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R01MH102242-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00091368

Identifier Type: -

Identifier Source: org_study_id