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Obsessive-Compulsive DisorderNCT05907369

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

A study testing Active EC training and Active tDCS in people with Obsessive-Compulsive Disorder, run by Ferdowsi University of Mashhad at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Active EC training and Active tDCS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteIran
Study dates
20 Jan 2023to 29 Mar 2024
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ali Moghimi, PhD contact

0098 09153176390

moghimi@um.ac.ir

Faezeh Raeisalmohaddesin, MsC contact

0098 09151232724

fh.raeesi@gmail.com

Iran1 site, 1 recruiting
  • Ferdowsi University of Mashhad

    Mashhad, Razavi Khorasan Province, 91779 48974

    Ali Moghimi, PhD, 0098 09153176390, moghimi@um.ac.ir

    Faezeh Raeisalmohaddesin, MsC, 0098 09151232724, fh.raeesi@gmail.com

    Recruiting

Other trials in Iran

About this study

Official title: Disgust Reduction Through Evaluative Conditioning and tDCS in Patients With Contamination-Based OCD

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.

Read the 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.

Being tested
Active EC training, Sham EC training, Active tDCS, Sham tDCS
Keywords
Obsessive-Compulsive Disorder, Contamination symptoms, Disgust, Evaluative Conditioning, Transcranial Direct Current Stimulation, Orbitofrontal Cortex
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.

  • Active EC trainingOther

    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.

  • Sham EC trainingOther

    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.

  • Active tDCSOther

    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).

  • Sham tDCSOther

    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).

Study groups in NCT05907369
Study groupRoleWhat they receive
aEC/ stDCSExperimentalParticipants in this group receive active EC training but sham tDCS.
Receives: Other: Active EC training; Other: Sham tDCS
sEC/atDCSActive comparatorParticipants in this group receive active tDCS training but sham EC training.
Receives: Other: Sham EC training; Other: Active tDCS
aEC/atDCSExperimentalParticipants in this group receive both active EC training and active tDCS.
Receives: Other: Active EC training; Other: Active tDCS
sEC/stDCSSham comparatorParticipants in this group receive the sham EC training and also sham tDCS.
Receives: Other: Sham EC training; Other: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)

  2. 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.

    Measured: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)

Secondary outcomes (3)
  1. 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.

    Measured: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)

  2. Attentional bias

    Change in attentional bias toward contamination stimuli, measured by Dot-prob test, comparing evaluative conditioning, cathodal tDCS over OFC, and both.

    Measured: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)

  3. Inhibitory control

    Change in inhibitory control, measured by go/nogo and stop-signal tests, comparing evaluative conditioning, cathodal tDCS over OFC, and both.

    Measured: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start20 Jan 2023
  3. Primary completion30 Dec 2023
  4. Study completion29 Mar 2024 (estimated)

Resources

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
Factorial
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
Single blind
Who is masked
Participant
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05907369
Sponsor's protocol ID
3/56765
Other IDs
100/18979
Status last verified
Sep 2023
First submitted
15 May 2023
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Raeis Al Mohaddesin F, Moghimi A, Kobravi H, Yaghoubian E, Salehi Fadardi J. Disgust-reduction evaluative conditioning (DREC) and tDCS in contamination-based OCD: a randomized controlled trial. BMC Psychiatry. 2026 Apr 6;26(1):414. doi: 10.1186/s12888-026-07934-0.

    PubMed 41942946
  • Al Mohaddesin FR, Moghimi A, Fadardi JS. Disgust-reduction evaluative conditioning (DREC) and brain stimulation in patients with contamination-based obsessive-compulsive disorder: a protocol for a randomized control trial. Trials. 2023 Nov 24;24(1):750. doi: 10.1186/s13063-023-07791-2.

    PubMed 38001473

Questions about this trial

What is this clinical trial studying?

A study testing Active EC training and Active tDCS in people with Obsessive-Compulsive Disorder, run by Ferdowsi University of Mashhad at 1 site in Iran.

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 4 inclusion and 8 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 Feb 2024. 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 Iran. 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. Some participants in this study may receive a placebo. 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 Ali Moghimi, PhD (0098 09153176390, moghimi@um.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). 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 NCT05907369, which also lists 2 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 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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