Obsessive-Compulsive DisorderAvoidOCDNCT04685018
The Neurocircuitry of Relief During Avoidance Learning in Patients With Obsessive-compulsive Disorder
An observational study of Obsessive-Compulsive Disorder, run by KU Leuven at 1 site in Belgium.
Trial summary
To investigate the neuro-mechanisms underpinning persistent avoidance in OCD patients Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- fMRI acquisition
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2020to 1 May 2022
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy group: Mentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition. OCD group: Same as the healthy group, except for the diagnosis of OCD and medication-free or with a stable medication regimen for at least 3 weeks prior to the study.
Who may be able to join
- Healthy volunteers 18-60 years old;
- Participants are motivated and give written informed consent;
- Adequate demand of Dutch language;
- Subjects have never participated in a fear conditioning task;
- Diagnosis of OCD (for OCD group only);
- Contraindications for the MRI exam.
Who cannot join
- Current neurological (e.g. Epilepsia), respiratory, cardiovascular, metabolic, gastrointestinal, endocrine (especially diabetes), renal or urinary diseases, psychiatric disorder or other relevant medical histories (except for OCD in the OCD group);
- Being pregnant or lactating;
- Alcohol intake greater than 14 alcoholic units per week (one alcoholic unit = 10 gr ethanol);
- History of cannabis use or any other drug of abuse during the 3 months prior to the study;
- The medical doctor has asked to the participant to stay away from stressful situations;
- Electronic implants (e.g., pacemaker);
- Pain or other condition of the hand or the wrist.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Psychiatry | UZ Leuven campus Gasthuisberg
Leuven, 3000
Bram Vervliet, Prof. Dr., +32 16 3 26145, bram.vervliet@kuleuven.be
Chris Bervoets, Prof. Dr., chris.bervoets@upckuleuven.be
About this study
To investigate the neuro-mechanisms underpinning persistent avoidance in OCD patients
Read the detailed description
Many compulsions displayed by obsessive-compulsive disorder (OCD) patients serve to protect against perceived threat and can, therefore, be conceptualized as 'avoidance responses'. Exposure treatment with response prevention (ET+RP) is aimed at exposing patients to their obsessive thoughts and perceived threats while preventing engagement in compulsive avoidant responses. This induces extinction of threat perception and fearful arousal and hence reduces the motivation to avoid. While successful in many patients, however, as much as 40% dropout during treatment or display persistent avoidance after ET+RP. There is a clear need for treatment improvement for these often highly disabled patients.
Improving ET+RP outcomes requires a deeper understanding of the mechanisms that drive excessive and persistent avoidance in OCD patients. Psychological theories ascribe an important role to the relief that follows avoidance when the anticipated threat is successfully averted. This positive feeling arguably functions as a reward to reinforce the foregoing avoidance actions. Indeed, fMRI studies have found that the neurocircuitry of relief overlaps with that of reward, including the ventral tegmental area, ventral striatum and orbitofrontal cortex. Here, the authors will test the hypothesis that excessive-persistent avoidance is linked to exaggerated activation of the relief circuitry in OCD patients. For that purpose, we will acquire functional brain images of OCD patients in an MRI scanner and compare to healthy participants, while they participate in a computer task that is designed to model avoidance learning and relief.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- fMRI acquisition
- Keywords
- Avoidance behavior, Reward, Conditioning, Extinction, Anxiety Disorders, OCD, fMRI
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI acquisitionDevice
Also called Behavioral task
Participants from the two groups will perform an avoidance-relief task inside an MRI scanner
| Study group | Role | What they receive |
|---|---|---|
| HC | Mentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition. Receives: Device: fMRI acquisition | |
| OCD | Adults between 18 and 60 years, with a diagnosis of Obsessive-Compulsive Disorder and medication-free or with stable medication regimen for at least 3 weeks prior to the study. Receives: Device: fMRI acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidance responses during the avoidance-relief task
Avoidance responses during avoidance learning and test will be recorded in terms of button press and Reaction times
Measured: 1 hour for avoidance task
Relief during the omissions of the US
Relief will be measured as:
Brain data during fMRI: whole-brain activations, as well as activations in specific regions of interest (ROI: VTA, NAcc, OFC) at the moment of the omissions of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task;
Individual ratings: relief pleasantness ratings measured on a Likert scale from 0 (neutral) to 3 (very pleasant) after each omission of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task;
Physiological data: skin conductance responses (SCR) at the moment of the omissions of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task.
Measured: 1 hour to perform the avoidance task
Secondary outcomes (3)
Tolerance to stress
The individual level of tolerance to distress will be measured via the self-administration of the Distress Tolerance Scale
Measured: 1 hour to perform the avoidance task
Therapeutic outcome in OCD
The therapeutic outcome in OCD individuals will be evaluated by using the Y-BOCS (self-administered) questionnaire
Measured: 1 hour to perform the avoidance task
Resting-state connectivity
The strength of connectivity between NAcc, VTA, and OFC, will be measured during the resting state MRI acquisition
Measured: 1 hour to perform the avoidance task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start10 Jan 2020
- Primary completion10 Jan 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 KU LeuvenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bram Vervliet, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685018
- Sponsor's protocol ID
- bram vervliet
- Acronym
- AvoidOCD
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vervliet B, Lange I, Milad MR. Temporal dynamics of relief in avoidance conditioning and fear extinction: Experimental validation and clinical relevance. Behav Res Ther. 2017 Sep;96:66-78. doi: 10.1016/j.brat.2017.04.011. Epub 2017 Apr 23.
PubMed 28457484Milad MR, Furtak SC, Greenberg JL, Keshaviah A, Im JJ, Falkenstein MJ, Jenike M, Rauch SL, Wilhelm S. Deficits in conditioned fear extinction in obsessive-compulsive disorder and neurobiological changes in the fear circuit. JAMA Psychiatry. 2013 Jun;70(6):608-18; quiz 554. doi: 10.1001/jamapsychiatry.2013.914.
PubMed 23740049Leknes S, Lee M, Berna C, Andersson J, Tracey I. Relief as a reward: hedonic and neural responses to safety from pain. PLoS One. 2011 Apr 7;6(4):e17870. doi: 10.1371/journal.pone.0017870.
PubMed 21490964Gillan CM, Morein-Zamir S, Urcelay GP, Sule A, Voon V, Apergis-Schoute AM, Fineberg NA, Sahakian BJ, Robbins TW. Enhanced avoidance habits in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):631-8. doi: 10.1016/j.biopsych.2013.02.002. Epub 2013 Mar 16.
PubMed 23510580
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurocircuitry of Relief During Avoidance Learning in Patients With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT04685018
- Acronym / sponsor ID
- AvoidOCD / bram vervliet
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Avoidance behavior, Reward, Conditioning, Extinction, Anxiety Disorders, OCD, fMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Jan 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 28 Dec 2020 (actual)
- 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.
To investigate the neuro-mechanisms underpinning persistent avoidance in OCD patients
Detailed description
Many compulsions displayed by obsessive-compulsive disorder (OCD) patients serve to protect against perceived threat and can, therefore, be conceptualized as 'avoidance responses'. Exposure treatment with response prevention (ET+RP) is aimed at exposing patients to their obsessive thoughts and perceived threats while preventing engagement in compulsive avoidant responses. This induces extinction of threat perception and fearful arousal and hence reduces the motivation to avoid. While successful in many patients, however, as much as 40% dropout during treatment or display persistent avoidance after ET+RP. There is a clear need for treatment improvement for these often highly disabled patients.
Improving ET+RP outcomes requires a deeper understanding of the mechanisms that drive excessive and persistent avoidance in OCD patients. Psychological theories ascribe an important role to the relief that follows avoidance when the anticipated threat is successfully averted. This positive feeling arguably functions as a reward to reinforce the foregoing avoidance actions. Indeed, fMRI studies have found that the neurocircuitry of relief overlaps with that of reward, including the ventral tegmental area, ventral striatum and orbitofrontal cortex. Here, the authors will test the hypothesis that excessive-persistent avoidance is linked to exaggerated activation of the relief circuitry in OCD patients. For that purpose, we will acquire functional brain images of OCD patients in an MRI scanner and compare to healthy participants, while they participate in a computer task that is designed to model avoidance learning and relief.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HC | – | Device: fMRI acquisitionMentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition. |
| OCD | – | Device: fMRI acquisitionAdults between 18 and 60 years, with a diagnosis of Obsessive-Compulsive Disorder and medication-free or with stable medication regimen for at least 3 weeks prior to the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy group: Mentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition. OCD group: Same as the healthy group, except for the diagnosis of OCD and medication-free or with a stable medication regimen for at least 3 weeks prior to the study.
Key inclusion criteria (6 listed)
- Healthy volunteers 18-60 years old;
- Participants are motivated and give written informed consent;
- Adequate demand of Dutch language;
- Subjects have never participated in a fear conditioning task;
- Diagnosis of OCD (for OCD group only);
Key exclusion criteria (7 listed)
- Current neurological (e.g. Epilepsia), respiratory, cardiovascular, metabolic, gastrointestinal, endocrine (especially diabetes), renal or urinary diseases, psychiatric disorder or other relevant medical histories (except for OCD in the OCD group);
- Being pregnant or lactating;
- Alcohol intake greater than 14 alcoholic units per week (one alcoholic unit = 10 gr ethanol);
- History of cannabis use or any other drug of abuse during the 3 months prior to the study;
- The medical doctor has asked to the participant to stay away from stressful situations;
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 |
|---|---|---|
| fMRI acquisitionAlso: Behavioral taskParticipants from the two groups will perform an avoidance-relief task inside an MRI scanner | Device | HC, OCD |
Primary outcome
Avoidance responses during the avoidance-relief task
Time frame: 1 hour for avoidance task
Avoidance responses during avoidance learning and test will be recorded in terms of button press and Reaction times
Relief during the omissions of the US
Time frame: 1 hour to perform the avoidance task
Relief will be measured as: Brain data during fMRI: whole-brain activations, as well as activations in specific regions of interest (ROI: VTA, NAcc, OFC) at the moment of the omissions of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task; Individual ratings: relief pleasantness ratings measured on a Likert scale from 0 (neutral) to 3 (very pleasant) after each omission of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task; Physiological data: skin conductance responses (SCR) at the moment of the omissions of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task.
3 secondary outcomes
Tolerance to stress
Time frame: 1 hour to perform the avoidance task
Therapeutic outcome in OCD
Time frame: 1 hour to perform the avoidance task
Resting-state connectivity
Time frame: 1 hour to perform the avoidance task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Results publication: PubMed 28457484Vervliet B, Lange I, Milad MR. Temporal dynamics of relief in avoidance conditioning and fear extinction: Experimental validation and clinical relevance. Behav Res Ther. 2017 Sep;96:66-78. doi: 10.1016/j.brat.2017.04.011. Epub 2017 Apr 23.
- Results publication: PubMed 23740049Milad MR, Furtak SC, Greenberg JL, Keshaviah A, Im JJ, Falkenstein MJ, Jenike M, Rauch SL, Wilhelm S. Deficits in conditioned fear extinction in obsessive-compulsive disorder and neurobiological changes in the fear circuit. JAMA Psychiatry. 2013 Jun;70(6):608-18; quiz 554. doi: 10.1001/jamapsychiatry.2013.914.
- Results publication: PubMed 21490964Leknes S, Lee M, Berna C, Andersson J, Tracey I. Relief as a reward: hedonic and neural responses to safety from pain. PLoS One. 2011 Apr 7;6(4):e17870. doi: 10.1371/journal.pone.0017870.
- Results publication: PubMed 23510580Gillan CM, Morein-Zamir S, Urcelay GP, Sule A, Voon V, Apergis-Schoute AM, Fineberg NA, Sahakian BJ, Robbins TW. Enhanced avoidance habits in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):631-8. doi: 10.1016/j.biopsych.2013.02.002. Epub 2013 Mar 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by KU Leuven at 1 site in Belgium.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Dec 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bram Vervliet, Prof. Dr. (+32 16 3 26 145, bram.vervliet@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Avoidance responses during the avoidance-relief task (time frame: 1 hour for avoidance task). The study lists 2 primary outcomes in all. 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 NCT04685018, which also lists 4 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 28 Dec 2020.