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comparative examination of mindfulness‑based compassion therapy and eye movement desensitization and reprocessing therapy with pharmacological control on emotion regulation, psychological adjustment, and anxiety in patients with obsessive–compulsive disorder

Protocol summary

Study aim
Comparing the effectiveness of two approaches: mindfulness-based compassion therapy and eye movement desensitization therapy, along with conventional drug treatment, on the psychological state of patients with obsessive-compulsive disorder
Design
Controlled clinical trial, with parallel groups, single-blind, individually randomized on 45 patients
Settings and conduct
Individuals with obsessive-compulsive disorder who visit the Armana Psychology Clinic in Yazd during the study will be included if they meet the eligibility criteria. Simple randomization will be used for allocation. This study is single-blind. Questionnaires will be recorded with anonymous codes and delivered to the outcome assessor and data analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from obsessive-compulsive disorder, minimum literacy, receiving consistent medication, full attendance at sessions; Exclusion criteria: history of psychotic disorders, history of suicide attempts, severe learning disabilities, drug use or alcohol dependence
Intervention groups
Intervention Group 1: Participants will undergo Mindfulness-Based Compassion Therapy (MBCT) according to the protocol developed by Pirzad et al. This intervention comprises 8 weekly sessions, with each session lasting 90 minutes. Intervention Group 2: Participants will undergo Eye Movement Desensitization and Reprocessing (EMDR) according to the protocol developed by Dressen et al. This intervention comprises 8 weekly sessions, with each session lasting 45 minutes. Control Group: Participants in this group will not receive any specific intervention.
Main outcome variables
Severity of obsessive-compulsive disorder symptoms; anxiety; psychological adjustment; emotion regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260604069641N1
Registration date: 2026-07-24, 1405/05/02
Registration timing: registered_while_recruiting

Last update: 2026-07-24, 1405/05/02
Update count: 0
Registration date
2026-07-24, 1405/05/02
Registrant information
Name
Sepideh Semsar Yazdi
Name of organization / entity
University of Science and Art, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 2747
Email address
sepidehsemsaryazdi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-26, 1405/04/05
Expected recruitment end date
2026-09-27, 1405/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative examination of mindfulness‑based compassion therapy and eye movement desensitization and reprocessing therapy with pharmacological control on emotion regulation, psychological adjustment, and anxiety in patients with obsessive–compulsive disorder
Public title
Comparison of psychological treatments for OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from obsessive-compulsive disorder (OCD) OCD of the type of contamination, washing and checking Treatment started less than six months ago in the sample Having minimum reading and writing skills to answer questionnaire questions Receive fixed drug treatment (Asentra 100 mg) Availability to fully attend therapy sessions
Exclusion criteria:
History of psychotic or bipolar disorders History of suicide attempt in the last 6 months Receiving other structured psychotherapy at the same time Starting, stopping, or changing the dose of psychiatric medication within 8 weeks prior to study entry Presence of severe learning disabilities or neurological disorders Drug use or alcohol dependence in the last 6 months
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to one of three groups—Mindfulness-Based Compassion Therapy (MBCT), Eye Movement Desensitization and Reprocessing (EMDR), or the control group—using a simple randomization method, with individual participants serving as the unit of randomization. To generate the allocation sequence, a series of random numbers will be produced using the random number generator function in SPSS (version 26.0). Allocation will be based on the generated numbers: numbers assigned to the MBCT group will be designated as ‘1’, numbers for the EMDR group as ‘2’, and numbers for the control group as ‘3’. To ensure strict allocation concealment, this sequence will be managed by an independent researcher who will have no involvement in the recruitment, clinical assessment, or treatment delivery. Prior to the start of the study, the independent researcher will prepare sequentially numbered, opaque, and sealed envelopes, each containing the group assignment (1, 2, or 3) based on the pre-generated random sequence. Upon enrollment and after obtaining written informed consent, the researcher/assessor will open the next available envelope in the sequence and assign the participant to the corresponding group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is conducted in a single-blind manner. Questionnaires are recorded with anonymous codes and delivered to the outcome assessor and data analyst.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Science and Culture, Jihad Daneshgahi
Street address
Bahar Ave., Shahid Ghamoshi., Ashrafi Esfahani Blvd
City
Tehran
Province
Tehran
Postal code
1461968151
Approval date
2026-05-09, 1405/02/19
Ethics committee reference number
IR.ACECR.USC.REC.1405.039

Health conditions studied

1

Description of health condition studied
Obsessions and compulsions
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
Severity of obsessive-compulsive symptoms (OCD)
Timepoint
Pre-intervention, immediately post-intervention, and 4 weeks post-intervention
Method of measurement
Clinical Assessment

Secondary outcomes

1

Description
Anxiety
Timepoint
Pre-intervention, immediately post-intervention, and 4 weeks post-intervention
Method of measurement
Beck Anxiety Inventory(Beck et al.,1990)

2

Description
Psychological adjustment
Timepoint
Pre-intervention, immediately post-intervention, and 4 weeks post-intervention
Method of measurement
Bell Adjustment Inventory(1961)

3

Description
emotion regulation
Timepoint
Pre-intervention, immediately post-intervention, and 4 weeks post-intervention
Method of measurement
Emotion Regulation Questionnaire(Gross & John,2003)

Intervention groups

1

Description
"Intervention group1:" The primary intervention is based on the Mindfulness-Based Compassion Training protocol, adapted from the model by Pirzad et al. (2024). This intervention will be conducted in eight weekly 90-minute sessions at the Armana Clinic in Yazd. Session 1: Introduction to Obsessive-Compulsive Disorder (OCD), mindfulness, and self-compassion, focusing on their role in reducing hopelessness. Exercises include breathing awareness and non-judgmental observation of obsessive thoughts. Session 2: Distinguishing between “thoughts,” “emotions,” and “obsessive behaviors,” emphasizing non-reactive observation. Practice of body scan with a compassionate approach toward unpleasant experiences. Session 3: Identifying difficult emotions associated with OCD (anxiety, shame, hopelessness) and fostering acceptance. Exercises focus on compassion-focused breathing and cultivating a sense of safety when facing threatening emotions. Session 4: Examining the role of self-blame and self-criticism in the maintenance of OCD. Practice of compassionate self-talk in response to obsessive thoughts and perceived mistakes. Session 5: Training in compassionate responses to obsessive thoughts as an alternative to avoidance or struggle. Exercises in experiencing acceptance with kindness, without the urge for immediate control. Session 6: Training in emotion regulation strategies based on the mindfulness and self-compassion model. Session 7: Practicing the “Mindful Pause” in OCD-triggering situations. Application of mindfulness and compassion to daily life challenges and OCD symptoms. Session 8: Mindful exposure to obsessive thoughts while maintaining a compassionate attitude. Review of acquired skills and the role of self-compassion in reducing hopelessness and enhancing psychological adjustment. Development of a personalized self-care and mindfulness plan for relapse prevention and sustained improvement.The therapeutic process is structured across eight distinct sessions, each carefully sequenced to build upon the foundational knowledge and skills established in preceding sessions. This hierarchical progression ensures that clients are adequately prepared and resourced at each stage, facilitating a systematic and cumulative approach to achieving therapeutic objectives.
Category
Treatment - Other

2

Description
"Intervention group 2:" The second intervention is based on the Eye Movement Desensitization and Reprocessing (EMDR) protocol, adapted from the model by Dreessen et al. (2024). This intervention will be implemented weekly in eight 45-minute sessions at the Armana Clinic in Yazd. Phase 1 (History Taking and Treatment Planning): Gathering baseline information, including family history, clinical background, current symptomatology, and the client’s existing social support system. Phase 2 (Preparation): Educating and preparing the client for processing traumatic memories. This phase involves teaching coping skills, pain management techniques, and relaxation exercises to be practiced between sessions. Phase 3 (Assessment): Identifying the target memory, selecting a negative cognition (NC), and establishing a positive cognition (PC). The client’s Subjective Units of Disturbance (SUD) scale and Validity of Cognition (VoC) scale are assessed and recorded. Phase 4 (Desensitization): The client focuses on the distressing image, negative beliefs, and associated physical sensations while receiving bilateral stimulation (BLS) through eye movements. This process continues until the intensity of the distress is reduced to a manageable level. Phase 5 (Installation): The goal is to strengthen the positive cognition and replace the negative belief associated with the traumatic memory with a more adaptive, positive one. Phase 6 (Body Scan): The client performs a head-to-toe body scan to identify any remaining physical tension. Bilateral stimulation is utilized to process and release these somatic sensations, fostering a sense of relief and well-being. Phase 7 (Closure): The client reflects on their current emotional and cognitive state. The therapist ensures the client ends the session in a stable and balanced state. Phase 8 (Re-evaluation): Reviewing treatment goals, conducting a follow-up assessment of the client’s progress, and concluding the therapy process.The therapeutic process is structured across eight distinct sessions, each carefully sequenced to build upon the foundational knowledge and skills established in preceding sessions. This hierarchical progression ensures that clients are adequately prepared and resourced at each stage, facilitating a systematic and cumulative approach to achieving therapeutic objectives.
Category
Treatment - Other

3

Description
Control group: will receive no therapeutic intervention during the study period, serving as a baseline for comparison with the experimental group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Armana Psychology Clinic
Full name of responsible person
Dr.Mohsen Saeidmanesh
Street address
Armana Psychology Clinic, Hazrat Abbas St., Jomhouri Eslami Blvd., Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945730
Phone
+98 35 3530 4351
Email
m.saeidmanesh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Science and Art, Yazd, Iran
Full name of responsible person
Dr.Javad Aghajani
Street address
University of Science and Art, Daneshjoo Blvd., Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916713335
Phone
+98 35 3826 4080
Fax
+98 35 3826 4090
Email
j.aghajani@sau.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Science and Art, Yazd, Iran
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
University of Science and Art, Yazd, Iran
Full name of responsible person
Sepideh Semsar Yazdi
Position
PhD Student in Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No.6, Alley 8, Amir Kabir Blvd, University Town,Yazd,Iran
City
Yazd
Province
Yazd
Postal code
8916147164
Phone
+98 35 3821 2747
Fax
Email
sepidehsemsaryazdi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Science and Art, Yazd, Iran
Full name of responsible person
Dr.Mohsen Saeidmanesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Armana Psychology Clinic, Hazrat Abbas St., Jomhouri Eslami Blvd., Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945730
Phone
+98 35 3530 4351
Email
m.saeidmanesh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Science and Art, Yazd, Iran
Full name of responsible person
Sepideh Semsar Yazdi
Position
PhD Student in Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No. 6, Alley 8, Amir Kabir Blvd., University Town, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8916147164
Phone
+98 35 3821 2747
Fax
Email
sepidehsemsaryazdi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect the privacy and confidentiality of the participants, raw individual-level data (IPD) will not be shared publicly. The study adheres to strict ethical guidelines regarding data protection to ensure that no participant can be identified from the shared information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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