Obsessive-Compulsive DisorderNCT02437773
Neurocircuit Mechanisms of OCD Across the Lifespan
A study testing Cognitive Behavioral Therapy - Adolescents, Stress Management Therapy - Adolescents and Optional CBT - Adolescents in people with Obsessive-Compulsive Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Behavioral Therapy - Adolescents, Stress Management Therapy - Adolescents and Optional CBT - Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2015to 21 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
- Additional Exclusion Criteria for Healthy Volunteers:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive Behavioral Therapy - Adolescents, Stress Management Therapy - Adolescents, Optional CBT - Adolescents, Cognitive Behavioral Therapy - Adults, Stress Management Therapy - Adults
- Keywords
- OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy - AdolescentsBehavioural
Also called CBT
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 - AdolescentsBehavioural
Also called SMT
An active control therapy with minimal effects on OCD symptoms.
Optional CBT - AdolescentsBehavioural
Also called CBT
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
Cognitive Behavioral Therapy - AdultsBehavioural
Also called 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.
Stress Management Therapy - AdultsBehavioural
Also called SMT
An active control therapy with minimal effects on OCD symptoms.
Optional CBT - AdultsBehavioural
Also called CBT
This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
fMRI only - Healthy Control AdultsOther
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.
fMRI only - Healthy Control AdolescentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy - Adolescents | Active comparator | 12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period. Receives: Behavioral: Cognitive Behavioral Therapy - Adolescents |
| Stress Management Therapy - Adolescents | Other | 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). Receives: Behavioral: Stress Management Therapy - Adolescents; Behavioral: Optional CBT - Adolescents |
| Cognitive Behavioral Therapy - Adults | Active comparator | 12 CBT sessions scheduled weekly over a 12-week period. Receives: Behavioral: Cognitive Behavioral Therapy - Adults |
| Stress Management Therapy - Adults | Other | 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). Receives: Behavioral: Stress Management Therapy - Adults; Behavioral: Optional CBT - Adults |
| Healthy Control - Adolescents | Other | 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). Receives: Other: fMRI only - Healthy Control Adolescents |
| Healthy Control - Adults | Other | 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). Receives: Other: fMRI only - Healthy Control Adults |
| Optional CBT - Adolescents | Other | 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. Receives: Behavioral: Optional CBT - Adolescents |
| Optional CBT - Adults | Other | 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. Receives: Behavioral: Optional CBT - Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start9 Mar 2015
- Primary completion13 Apr 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kate D. Fitzgerald, University of Michigan
- Investigators
- Kate Fitzgerald, MD, Principal investigator, University of Michigan, Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437773
- Sponsor's protocol ID
- HUM00091368
- Other IDs
- R01MH102242-01A1
- Status last verified
- Nov 2020
- First submitted
- 2 May 2015
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38103359Rueppel 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.
PubMed 34966981Norman 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.
PubMed 32854533
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocircuit Mechanisms of OCD Across the Lifespan
- ClinicalTrials.gov ID
- NCT02437773
- Acronym / sponsor ID
- HUM00091368
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy - Adolescents | Active comparator | Behavioral: Cognitive Behavioral Therapy - Adolescents12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period. |
| Stress Management Therapy - Adolescents | Other | Behavioral: Stress Management Therapy - Adolescents, Behavioral: Optional CBT - Adolescents12 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 comparator | Behavioral: Cognitive Behavioral Therapy - Adults12 CBT sessions scheduled weekly over a 12-week period. |
| Stress Management Therapy - Adults | Other | Behavioral: Stress Management Therapy - Adults, Behavioral: Optional CBT - Adults12 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 | Other | Other: fMRI only - Healthy Control AdolescentsHealthy 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 | Other | Other: fMRI only - Healthy Control AdultsHealthy 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 | Other | Behavioral: Optional CBT - AdolescentsOCD 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 | Other | Behavioral: Optional CBT - AdultsOCD 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. |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy - AdolescentsAlso: CBTA therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates. | Behavioural | Cognitive Behavioral Therapy - Adolescents |
| Stress Management Therapy - AdolescentsAlso: SMTAn active control therapy with minimal effects on OCD symptoms. | Behavioural | Stress Management Therapy - Adolescents |
| Optional CBT - AdolescentsAlso: CBTThis is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment. | Behavioural | Optional CBT - Adolescents, Stress Management Therapy - Adolescents |
| Cognitive Behavioral Therapy - AdultsAlso: CBTA therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates. | Behavioural | Cognitive Behavioral Therapy - Adults |
| Stress Management Therapy - AdultsAlso: SMTAn active control therapy with minimal effects on OCD symptoms. | Behavioural | Stress Management Therapy - Adults |
| Optional CBT - AdultsAlso: CBTThis is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment. | Behavioural | Optional CBT - Adults, Stress Management Therapy - Adults |
| fMRI only - Healthy Control AdultsTwo 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. | Other | Healthy Control - Adults |
| fMRI only - Healthy Control AdolescentsTwo 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. | Other | Healthy Control - Adolescents |
Primary outcome
Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans
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.
1 secondary outcome
OCD symptom severity measured by the Yale Brown Obsessive Compulsive Scale for adults or the Child Yale Brown Obsessive Compulsive Scale for adolescents.
Time frame: Baseline to 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 38103359Himle 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.
- Derived from this study: PubMed 34966981Rueppel 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.
- Derived from this study: PubMed 32854533Norman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Fitzgerald, MD principal investigator
University of Michigan, Dept of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy - Adolescents, Stress Management Therapy - Adolescents and Optional CBT - Adolescents in people with Obsessive-Compulsive Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans (time frame: Baseline to 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437773, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.