Evaluating the effectiveness of exposure techniques in the treatment of obsessive-compulsive disorder and their application in working with patients diagnosed with OCD
Design
The study is a parallel-group clinical trial conducted on 30 patients diagnosed with obsessive-compulsive disorder (OCD).
Settings and conduct
The study will be conducted in Kurdistan Province (Sanandaj city) at the Psychology Clinic of Ghods Hospital. After screening and random allocation without knowledge of their assigned group, participants will enter the study. The statistical assessor will also be blinded to the group assignments. Additionally, participants will not incur any costs for the services provided
Participants/Inclusion and exclusion criteria
inclusion criteria:
• Willingness to participate in the study
• Ability to read and write at a middle school level
• Diagnosis of obsessive-compulsive disorder (OCD) based on a psychiatric evaluation
• Not currently undergoing any psychotherapy
• No changes in medication during the psychotherapy period
Not inclusion criteria:
• Presence of a psychotic disorder or lack of insight in OCD
• Having intellectual or cognitive impairments such as intellectual disability, dementia, or delirium
• Concurrent substance use disorders
Intervention groups
The study includes two groups: one group receives a structured and direct intervention of mindfulness-based exposure and response prevention (ERP), while the other group does not receive any specific intervention concurrently. The intervention program is based on a protocol that integrates cognitive-behavioral therapy with mindfulness.
Main outcome variables
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Depression Anxiety and Stress Scale
Anxiety sensetivity index 3
Multidimensional Assessment of Interoceptive Awareness-2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220113053705N2
Registration date:2025-07-06, 1404/04/15
Registration timing:registered_while_recruiting
Last update:2025-07-06, 1404/04/15
Update count:0
Registration date
2025-07-06, 1404/04/15
Registrant information
Name
Fateh Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3371 8025
Email address
f.sohrabi20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-02, 1404/04/11
Expected recruitment end date
2025-12-02, 1404/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Minfdul Interoceptive Exposure on improvement of symptoms of patients with Obsessive Compulsive Disorder
Public title
The effectiveness of Minfdul Interoceptive Exposure on improvement of OCD symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Willingness to participate in the study
• Ability to read and write at a middle school level
• Diagnosis of obsessive-compulsive disorder (OCD) based on a psychiatric evaluation
• Not currently undergoing any psychotherapy
• No changes in medication during the psychotherapy period
Exclusion criteria:
• Presence of a psychotic disorder or lack of insight in OCD
• Having intellectual or cognitive impairments such as intellectual disability, dementia, or delirium
• Concurrent substance use disorders
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying and selecting eligible participants, they will be randomly assigned to the study groups through a lottery method. Specifically, the participants’ names will be written on identical cards, which will then be randomly drawn from a designated container to divide the individuals into intervention and control groups. This approach is used to eliminate any potential bias in the allocation process and to enhance the internal validity of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
During the data analysis phase, the clinical evaluator or researcher reviewing the data is kept unaware of the participants' group assignments and their characteristics. The data are coded or anonymized in a way that prevents the evaluator from identifying which data belongs to which group. This procedure helps prevent evaluator bias in interpreting and assessing the data, thereby enhancing the validity of the study results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committees of Kurdistan university of medical sciences
Street address
Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
۱۵۱۷۵-۶۶۱۷۷
Approval date
2025-06-10, 1404/03/20
Ethics committee reference number
IR.MUK.REC.1404.089
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Timepoint
Before the intervention starts – after completing the treatment sessions – and three months after the last session
Method of measurement
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
2
Description
Anxiety Sensitivity Index-3
Timepoint
Before the intervention starts – after completing the treatment sessions – and three months after the last session
Method of measurement
Anxiety Sensitivity Index-3
3
Description
Multidimensional Assessment of Interoceptive Awareness-2
Timepoint
Before the intervention starts – after completing the treatment sessions – and three months after the last session
Method of measurement
Multidimensional Assessment of Interoceptive Awareness-2
4
Description
Depression, Anxiety and Stress scale
Timepoint
Before the intervention starts – after completing the treatment sessions – and three months after the last session
Method of measurement
Depression, Anxiety and Stress scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives mindfulness-based exposure therapy as the treatment, which consists of four therapy sessions with specific goals and strategies. Details of the weekly sessions are provided in Table 1. This therapy is a third-wave cognitive-behavioral treatment and is one of the transdiagnostic approaches that utilize mindfulness skill training along with cognitive-behavioral techniques. All sessions (Sessions 1–8) are outlined according to the relevant protocol (Sohrabi et al., 2024; Kiyon, 2011; Kiyon, Francis & Shirz, 2018).The primary goal of the therapy, following the therapeutic contract and client preparation, is to facilitate the process of change, which continues with several main objectives pursued across multiple sessions. The first phase is introversion, which focuses on developing attention skills, attention restoration, and attention regulation within the context of emotion regulation, using mindfulness techniques.Next, in the extroversion phase, the learned skills provide a basis for confronting intrapersonal problems, employing mindful exposure techniques to address harmful personal contexts. Then, as skills expand, the interpersonal and extrapersonal phases broaden this confrontation to wider interpersonal contexts. Finally, these stages are integrated into a comprehensive therapeutic package.
Category
Treatment - Other
2
Description
Control group: After being assigned to the control group, participants do not receive any specific psychotherapeutic intervention concurrently and continue to receive only their usual medication treatment.
kirdistan University of Medica sciences- Pasdaran Ave.
City
ُsanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷۱۳۱۴۱
Phone
+98 87 3366 4664
Email
Fardin8725@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
kurdistan 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
Sanandaj University of Medical Sciences
Full name of responsible person
Fateh Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Clinical Psychology Branch, Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4664
Email
f.sohrabi20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fateh Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Clinical Psychology Branch, Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4664
Email
F.sohrabi20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fateh Sohrabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Clinical Psychology Branch, Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4664
Email
f.sohrabi20@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data related to the study will be provided in response to legitimate requests from the relevant organizations.
When the data will become available and for how long
After publication of the data
To whom data/document is available
Academic researchers can access the data upon submitting a formal and justified request.
Under which criteria data/document could be used
The individual must have a verified identity and submit the request through an official or academic organization. They must accept responsibility for maintaining confidentiality and not disclosing the data without permission, in accordance with ethical principles.
From where data/document is obtainable
They can correspond via the following email to make a request:
F.sohrabi20@gmail.com
What processes are involved for a request to access data/document
After receiving the email and reviewing it through official channels, the request will be responded to as soon as possible.