NCT04685018

Brief Summary

To investigate the neuro-mechanisms underpinning persistent avoidance in OCD patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 10, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 14, 2020

Last Update Submit

December 21, 2020

Conditions

Keywords

Avoidance behaviorRewardConditioningExtinctionAnxiety DisordersOCDfMRI

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 hour to perform the avoidance task

Secondary Outcomes (3)

  • Tolerance to stress

    1 hour to perform the avoidance task

  • Therapeutic outcome in OCD

    1 hour to perform the avoidance task

  • Resting-state connectivity

    1 hour to perform the avoidance task

Study Arms (2)

HC

Mentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition.

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.

Device: fMRI acquisition

Interventions

Participants from the two groups will perform an avoidance-relief task inside an MRI scanner

Also known as: Behavioral task
HCOCD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry | UZ Leuven campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Related Publications (4)

  • 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.

  • Milad 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.

  • Leknes 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.

  • Gillan 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.

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Bram Vervliet, Prof. Dr.

CONTACT

Chris Bervoets, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Prof. Dr. Bram Vervliet

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 28, 2020

Study Start

January 10, 2020

Primary Completion

January 10, 2022

Study Completion

May 1, 2022

Last Updated

December 28, 2020

Record last verified: 2020-12

Locations