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Comparison of the Effectiveness of Mindfulness-Integrated Cognitive Behavioral Therapy (MiCBT) and Exposure and Response Prevention (ERP) in Individuals with Obsessive-Compulsive Disorder with a History of Childhood Maltreatment

Protocol summary

Study aim
Comparison of the Effectiveness of Mindfulness-Integrated Cognitive Behavioral Therapy (MiCBT) and Exposure and Response Prevention (ERP) in Individuals with Obsessive Compulsive Disorder with a History of Childhood Maltreatment.
Design
The clinical trial has two intervention groups (in parallel), double-blind, with a total of 62 people randomized using the rand function of Excel software.
Settings and conduct
This study will be conducted at the psychiatric and psychological outpatient clinics of Shahid Beheshti University of Medical Sciences. Patients who obtain at least a moderate score on one of the CTQ subscales will be assessed using the SCID-5-CV to confirm the presence of depressive and anxiety disorders. Participants will be evaluated at three time points: pre-test, post-test, and follow-up. In this study, both participants and the statistical analyst will be blinded to the type of intervention
Participants/Inclusion and exclusion criteria
IInclusion criteria: Age 18–65 years, DSM-5-TR diagnosis of OCD confirmed by SCID-5-CV, a history of childhood maltreatment (moderate to severe score on at least one CTQ subscale), stable psychiatric medication for at least 4 weeks prior to treatment with no medication changes during the study, and provision of written informed consent. Exclusion criteria: Concurrent psychotherapy, severe cognitive or neurological disorders, substance or alcohol use disorders, psychotic disorders, suicidal ideation or suicide attempt during treatment, and absence from more than two treatment sessions.
Intervention groups
ERP group: 12 individual 60-90 minute sessions over 12 weeks. MiCBT group: 10 individual 60-90 minute sessions over 10 weeks.
Main outcome variables
Severity of obsessive-compulsive symptoms, Internalized shame, Obsessive beliefs, Emotion regulation and experiential avoidance

General information

Reason for update
Acronym
MiCBT, ERP
IRCT registration information
IRCT registration number: IRCT20260421069122N1
Registration date: 2026-07-06, 1405/04/15
Registration timing: prospective

Last update: 2026-07-06, 1405/04/15
Update count: 0
Registration date
2026-07-06, 1405/04/15
Registrant information
Name
Farnaz Doostdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9945
Email address
f.doostdari@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-22, 1405/05/31
Expected recruitment end date
2027-05-22, 1406/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Mindfulness-Integrated Cognitive Behavioral Therapy (MiCBT) and Exposure and Response Prevention (ERP) in Individuals with Obsessive-Compulsive Disorder with a History of Childhood Maltreatment
Public title
Comparison of the Effectiveness of MiCBT and ERP in Individuals with Obsessive-Compulsive Disorder with a History of Childhood Maltreatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 to 65 years Providing written informed consent to participate in the study A diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5-TR criteria, established using the Structured Clinical Interview for DSM-5, Clinician Version (SCID-5-CV) A history of childhood maltreatment, defined as obtaining a score in the moderate-to-severe range on at least one subscale of the Childhood Trauma Questionnaire (CTQ) For participants receiving pharmacotherapy, maintaining a stable medication regimen for at least four weeks before the intervention and throughout the study period, with no changes in medication type or dosage
Exclusion criteria:
Inability to read and write Receiving concurrent psychotherapy (individual or group therapy) during the study period Severe cognitive or neurological disorders (e.g., intellectual disability, dementia, or organic brain disorders) that preclude meaningful participation in the intervention. Diagnosis of severe psychiatric disorders (e.g., psychotic disorders or bipolar disorder) based on the Structured Clinical Interview for DSM-5, Clinician Version (SCID-5-CV). Emergence of suicidal ideation or a suicide attempt during the course of treatment. Substance and alcohol abuse or dependence.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was employed. Randomization was performed using a random number table. For each participant, a random number between 0 and 1 was generated. Participants with random values greater than or equal to 0.5 were assigned to the Mindfulness-Integrated Cognitive Behavioral Therapy (MiCBT) group, whereas those with random values less than 0.5 were assigned to the Exposure and Response Prevention (ERP) group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the statistical analyst will be blinded to the intervention conditions. Participants will not be informed about the specific type of intervention they receive, and the analyst responsible for data analysis will have no knowledge of group allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2025-11-05, 1404/08/14
Ethics committee reference number
IR.SBMU.MSP.REC.1404.483

Health conditions studied

1

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-Compulsive Disorder (OCD)

Primary outcomes

1

Description
Severity of obsessive-compulsive symptom
Timepoint
Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention.
Method of measurement
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary outcomes

1

Description
Emotion dysregulation
Timepoint
Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention.
Method of measurement
Difficulties in Emotion Regulation Scale–Short Form (DERS-SF)

2

Description
Obsessive beliefs
Timepoint
Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention.
Method of measurement
Short Form of Obsessive Beliefs Questionnaire (OBQ-20)

3

Description
experiential Avoidance
Timepoint
Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention.
Method of measurement
Acceptance and Action Questionnaire-II (AAQ-II)

4

Description
Internalized Shame
Timepoint
Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention.
Method of measurement
Internalized Shame Scale (ISS)

Intervention groups

1

Description
Intervention group: Mindfulness integrated of cognitive behavioral therapy. Participants will participate in ten structured 60- to 90-minute MICBT sessions, conducted according to the standard Bruno Cayon protocol. It emphasizes components such as improving emotion regulation, enhancing cognitive flexibility and mindfulness, and reducing avoidance of situations that trigger obsessive thoughts and compulsive behaviors
Category
Treatment - Other

2

Description
Intervention group: Exposure and Response Prevention (ERP) therapy will be administered in twelve 60-90 minute sessions based on the standard Edna Foa protocol.. This intervention focuses on gradual exposure to obsession-triggering stimuli and prevention of compulsive responses to reduce anxiety and obsessive-compulsive symptoms.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric and psychological outpatient clinics affiliated with Shahid Beheshti University of Medic
Full name of responsible person
Hoda Doosalivand
Street address
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 993 051 8701
Email
doosalivand.h@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iranf Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Doostdari
Position
Ph.D student in Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 7, No. 29, Mosivand Alley, Qazvin Street
City
Tehran
Province
Tehran
Postal code
1333983181
Phone
+98 21 2243 9945
Fax
Email
f.doostdari@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hoda Doos Alivand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 23871
Fax
Email
doosalivand.h@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Doostdari
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 29, Mousavand Alley, Qazvin Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333983181
Phone
+98 21 2243 9945
Email
farnazdoostdari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying individuals, including the following: 1. Demographic data; 2. Data related to independent and dependent variables at pre-test, post-test, and follow-up.
When the data will become available and for how long
Start of access period before results are printed
To whom data/document is available
No restrictions
Under which criteria data/document could be used
Writing and publishing articles based on the data from this study is not permitted.
From where data/document is obtainable
Send your request to farnazdoostdari@gmail.com. 2. Visit the OSF.io website.
What processes are involved for a request to access data/document
The data is available online at the mentioned site.
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