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Disgust Reduction Through Evaluative Conditioning (DREC) and tDCS in Contamination-Based OCD

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Active EC training
Sham EC training
Active tDCS
Sham tDCS
Sponsored by
Ferdowsi University of Mashhad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Contamination symptoms, Disgust, Evaluative Conditioning, Transcranial Direct Current Stimulation, Orbitofrontal Cortex

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5-TR) with the symptoms of contamination subtype Able to read, write and do computerized tasks Stable medication for at least the last three months Filling out the written consent Exclusion Criteria: Severe physical illness Severe other mental disorders Alcohol and drug dependence A history of epilepsy or seizure Have metal or electronic implants in the head or use a cardiac pacemaker History of head trauma or neurological disorders Women who are pregnant or may be pregnant Unable to complete questionnaires, computerized tasks, or informed consent

Sites / Locations

  • Ferdowsi University of MashhadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Sham Comparator

Arm Label

aEC/ stDCS

sEC/atDCS

aEC/atDCS

sEC/stDCS

Arm Description

Participants in this group receive active EC training but sham tDCS.

Participants in this group receive active tDCS training but sham EC training.

Participants in this group receive both active EC training and active tDCS.

Participants in this group receive the sham EC training and also sham tDCS.

Outcomes

Primary Outcome Measures

Disgust Feeling
Effect of evaluative conditioning, cathodal tDCS over OFC, and both on changing disgust feeling intensity measured by disgust rating scale. The scale rates from 0 (not disgusting) to 10 (very disgusting). Lower scores show less disgust feeling.
Clinical Symptoms Severity of Contamination-Based OCD
Change in Clinical symptoms of contamination-based OCD after evaluative conditioning, cathodal tDCS over OFC, and both, measured by Yale-Brown Obsessive-Compulsive scale. It is scored on a 5-point rating. The lower scores show less symptom severity.

Secondary Outcome Measures

The power spectrum of brain waves based on quantitative electroencephalogram
Effect of evaluative conditioning, cathodal tDCS over OFC, and both on power spectrum of recorded brain waves.
Attentional bias
Change in attentional bias toward contamination stimuli, measured by Dot-prob test, comparing evaluative conditioning, cathodal tDCS over OFC, and both.
Inhibitory control
Change in inhibitory control, measured by go/nogo and stop-signal tests, comparing evaluative conditioning, cathodal tDCS over OFC, and both.

Full Information

First Posted
May 15, 2023
Last Updated
September 11, 2023
Sponsor
Ferdowsi University of Mashhad
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1. Study Identification

Unique Protocol Identification Number
NCT05907369
Brief Title
Disgust Reduction Through Evaluative Conditioning (DREC) and tDCS in Contamination-Based OCD
Official Title
Disgust Reduction Through Evaluative Conditioning and tDCS in Patients With Contamination-Based OCD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ferdowsi University of Mashhad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Obsessive-compulsive disorder (OCD) is a debilitating health condition that is known by intrusive and unwanted thoughts and repetitive behavioral or mental acts. 2-3% of the population suffers from OCD in their lifetime. The most common OCD subtype is contamination. The Serotonin-selective reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT) based on exposure and response prevention (ERP) technique are the first-line treatments for OCD. The challenge is that nearly half do not respond to the first-line treatments or have residual symptoms after completion of treatments. However, the prevalence of the disorder, diversity of symptoms, inadequate response rate, and necessity of having long-lasting treatment effects make the treatments of OCD more challenging. It seems that abnormal, more intense disgust experience has a prominent role in developing and maintaining OCD symptoms, particularly the contamination subtype. Evaluative conditioning (EC), defined as transferring the value of the US to the CS through pairing them, is the most common way of establishing disgust responses. The present study aims to develop an emotion-based intervention technique using EC targeting disgust emotion in contamination-based OCD (C-OCD). The hypothesis is that EC training may modify disgust experiences. Disgust may be the culprit, at least in part, of cognitive deficiencies in OCD. The other hypothesis is whether disgust reduction-focused EC may improve cognitive function, such as attention bias and inhibitory control. The orbitofrontal cortex (OFC) is one of the brain areas engaged in disgust processing and is mostly hyperactive in OCD patients. Cathodal transcranial direct current stimulation (tDCS) over OFC is one of the helpful neuromodulation methods in treating OCD. We aim to see if this method may help to regulate disgust experiences in combination with EC. The participants may be referred by psychiatrists or psychotherapists or be self-referred due to online advertisements or paper flyers. They will be randomly assigned to one of for arms of the study for sham or active EC training along with sham or active tDCS, to which they are blind. The novelty of the present study is the application of EC training in the clinical OCD population in combination with a neuromodulation method.
Detailed Description
Disgust as a primary emotion has evolved to protect our lives by driving dirt and disease avoidance behaviors and motivating for cleaning and hygienic behaviors. In recent years, many studies have focused on the role of disgust in psychiatric disorders such as anxiety disorders, eating disorders, body dysmorphic disorders, and phobias. Nowadays, we have robust evidence of the correlation between disgust and the etiology and treatment of OCD symptoms, particularly the contamination subtype. The principal explanation for the insufficient treatment effect of ERP is that disgust is resistant to extinction. Since evaluative conditioning is one of the main sources of disgust feeling, the same process may effectively reduce disgust. The present trial will try to pair contamination-related pictures that are disgust-eliciting with positive, pleasant pictures in order to modify their disgust valence. We also will administer this EC training plus to OFC cathodal tDCS to see if the EC effect becomes more significant than EC alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Contamination symptoms, Disgust, Evaluative Conditioning, Transcranial Direct Current Stimulation, Orbitofrontal Cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The two interventions include evaluative conditioning (EC) training and cathodal tDCS over OFC. Each is present in two forms: active and sham. So, there are four interventional conditions, including sham EC-sham tDCS, active EC- sham tDCS, sham EC-active tDCS, and active EC-active tDCS.
Masking
Participant
Masking Description
Participants are blind to which of the interventions is active or a sham. Interventional sessions look the same for all participants regarding duration and activities (including doing a computerized EC task and receiving tDCS).
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aEC/ stDCS
Arm Type
Experimental
Arm Description
Participants in this group receive active EC training but sham tDCS.
Arm Title
sEC/atDCS
Arm Type
Active Comparator
Arm Description
Participants in this group receive active tDCS training but sham EC training.
Arm Title
aEC/atDCS
Arm Type
Experimental
Arm Description
Participants in this group receive both active EC training and active tDCS.
Arm Title
sEC/stDCS
Arm Type
Sham Comparator
Arm Description
Participants in this group receive the sham EC training and also sham tDCS.
Intervention Type
Other
Intervention Name(s)
Active EC training
Intervention Description
The active EC includes pairing contamination-related pictures (CSs) with pleasant pictures (USs). The EC training takes about 15 minutes and is administered for ten sessions (5 days a week) in 4 difficulty levels.
Intervention Type
Other
Intervention Name(s)
Sham EC training
Intervention Description
The active EC includes pairing contamination-related pictures (CSs) with neutral pictures (USs). The EC training takes about 15 minutes and is administered for ten sessions (5 days a week) in 4 difficulty levels, the same as active EC training.
Intervention Type
Other
Intervention Name(s)
Active tDCS
Intervention Description
For the active tDCS, the cathode is placed over the left OFC and the anode over the right cerebellum. The brain stimulation is delivered with a 2mA current intensity for 20 minutes in 10 sessions (5 days a week).
Intervention Type
Other
Intervention Name(s)
Sham tDCS
Intervention Description
For the sham tDCS, the cathode is placed over the left OFC and the anode over the right cerebellum, the same as active tDCS. The device is on for 20 minutes, but the current intensity is under the threshold of affecting cortical activity modulation. The participants receive the sham tDCS in 10 sessions (5 days a week).
Primary Outcome Measure Information:
Title
Disgust Feeling
Description
Effect of evaluative conditioning, cathodal tDCS over OFC, and both on changing disgust feeling intensity measured by disgust rating scale. The scale rates from 0 (not disgusting) to 10 (very disgusting). Lower scores show less disgust feeling.
Time Frame
From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)
Title
Clinical Symptoms Severity of Contamination-Based OCD
Description
Change in Clinical symptoms of contamination-based OCD after evaluative conditioning, cathodal tDCS over OFC, and both, measured by Yale-Brown Obsessive-Compulsive scale. It is scored on a 5-point rating. The lower scores show less symptom severity.
Time Frame
From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)
Secondary Outcome Measure Information:
Title
The power spectrum of brain waves based on quantitative electroencephalogram
Description
Effect of evaluative conditioning, cathodal tDCS over OFC, and both on power spectrum of recorded brain waves.
Time Frame
From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)
Title
Attentional bias
Description
Change in attentional bias toward contamination stimuli, measured by Dot-prob test, comparing evaluative conditioning, cathodal tDCS over OFC, and both.
Time Frame
From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)
Title
Inhibitory control
Description
Change in inhibitory control, measured by go/nogo and stop-signal tests, comparing evaluative conditioning, cathodal tDCS over OFC, and both.
Time Frame
From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5-TR) with the symptoms of contamination subtype Able to read, write and do computerized tasks Stable medication for at least the last three months Filling out the written consent Exclusion Criteria: Severe physical illness Severe other mental disorders Alcohol and drug dependence A history of epilepsy or seizure Have metal or electronic implants in the head or use a cardiac pacemaker History of head trauma or neurological disorders Women who are pregnant or may be pregnant Unable to complete questionnaires, computerized tasks, or informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Moghimi, PhD
Phone
0098 09153176390
Email
moghimi@um.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Faezeh Raeisalmohaddesin, MsC
Phone
0098 09151232724
Email
fh.raeesi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Moghimi, PhD
Organizational Affiliation
Ferdowsi University of Mashhad
Official's Role
Study Director
Facility Information:
Facility Name
Ferdowsi University of Mashhad
City
Mashhad
State/Province
Khorassan Razavi
ZIP/Postal Code
91779 48974
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Moghimi, PhD
Phone
0098 09153176390
Email
moghimi@um.ac.ir
First Name & Middle Initial & Last Name & Degree
Faezeh Raeisalmohaddesin, MsC
Phone
0098 09151232724
Email
fh.raeesi@gmail.com
First Name & Middle Initial & Last Name & Degree
Faezeh Raeisolmohaddesin, MsC

12. IPD Sharing Statement

Plan to Share IPD
No

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Disgust Reduction Through Evaluative Conditioning (DREC) and tDCS in Contamination-Based OCD

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