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The effect of compassion-focused therapy on functional connectivity of brain networks and psychological symptoms in individuals with major depressive disorder

Protocol summary

Study aim
Effect of Compassion-Focused Therapy on Brain Connectivity and Psychological Symptoms in Major Depressive Disorder
Design
This study is a randomized controlled clinical trial conducted with 40 individuals diagnosed with major depressive disorder. After screening, participants are randomly assigned to two groups: experimental group (20 individuals) and control group (20 individuals
Settings and conduct
After obtaining the ethics code from the Ethics Committee of Shahid Beheshti University of Medical Sciences, 40 patients with major depressive disorder based on DSM-5-TR criteria will be referred by a collaborating psychiatrist. Then, initial assessments will be conducted by the researcher to check compliance with inclusion and exclusion criteria. Patients will then be randomly assigned to two groups: experimental and control.
Participants/Inclusion and exclusion criteria
Participants: 40 patients. Inclusion: Age 18-50 years, PHQ-9 score (10-27), informed consent, medication stability, no claustrophobia, no pregnancy or metal in body Exclusion: Absence from more than two sessions, withdrawal, or active suicidal ideation.
Intervention groups
The experimental group receives Compassion-Focused Therapy (CFT) based on Gilbert's standard protocol in 12 weekly 90-minute sessions. The control group receives pharmacotherapy during this period.
Main outcome variables
Change in functional connectivity of brain networks (DMN, SAN, CEN) measured by resting-state fMRI; Reduction in the severity of depressive symptoms based on the Patient Health Questionnaire-9 (PHQ-9) score; Reduction in depression severity based on the Hamilton Rating Scale for Depression score.

General information

Reason for update
Acronym
CFT
IRCT registration information
IRCT registration number: IRCT20260607069694N1
Registration date: 2026-07-02, 1405/04/11
Registration timing: prospective

Last update: 2026-07-02, 1405/04/11
Update count: 0
Registration date
2026-07-02, 1405/04/11
Registrant information
Name
Ghazaleh آذر
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2661 4755
Email address
ghazalehazar.8540@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-22, 1405/07/30
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of compassion-focused therapy on functional connectivity of brain networks and psychological symptoms in individuals with major depressive disorder
Public title
The effect of compassion-focused therapy on functional connectivity of brain networks and psychological symptoms in individuals with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Major Depressive Disorder (MDD) based on a structured clinical interview conducted by a psychiatrist and a clinical psychologist Age between 18 and 50 years. A score between 10 and 27 on the Patient Health Questionnaire (PHQ-9) Ability to understand and complete the questionnaires (minimum educational level: middle school/junior high school) Provision of written informed consent for participation in the study and undergoing fMRI scanning Stable medication regimen during Compassion-Focused Therapy (CFT) No severe claustrophobia that would interfere with undergoing fMRI scanning Ability to remain motionless in the scanner for approximately 30 minutes No significant physical health problems or medical conditions, including pregnancy, that would contraindicate fMRI scanning. No diagnosis of bipolar disorder, psychotic disorders, or severe neurological disorders. No active use of illicit drugs or alcohol. No history of traumatic brain injury, epilepsy, or neurological diseases affecting brain function.
Exclusion criteria:
Active suicidal ideation with plan and intent. Inability to undergo fMRI scanning after the intervention due to any medical or technical reason. Voluntary withdrawal from the study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After eligibility confirmation, the randomization sequence will be generated by an independent individual using random number generation software. The sequence will be placed in opaque, identical, numbered envelopes and kept inaccessible to the principal investigator until allocation. Following the completion of baseline assessments, the principal investigator will open each patient's envelope sequentially and assign them to experimental or control groups based on the number inside. The outcome assessor will be blinded to group allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Approval date
2026-06-07, 1405/03/17
Ethics committee reference number
IR.SBMU.MSP.REC.1405.161

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder (MDD)
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Major Depressive Disorder (MDD)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Change in functional connectivity of brain networks (DMN, SAN, CEN)
Timepoint
Before the start of the intervention and after the completion of the intervention
Method of measurement
fMRI

2

Description
Reduction in the severity of depressive symptoms
Timepoint
Before the start of the intervention and after the completion of the intervention
Method of measurement
Patient Health Questionnaire-9 (PHQ-9). Hamilton Rating Scale for Depression (HAM-D)

Secondary outcomes

1

Description
Increase in self-compassion score
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
Self-Compassion Scale (Short Form)

2

Description
Reduction in rumination score
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
Ruminative Response Scale

3

Description
Reduction in external shame score
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
External Shame Scale

4

Description
Increase in quality of life score
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire (Brief Version)

5

Description
Reduction in depression, anxiety, and stress scores
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
Depression, Anxiety, and Stress Scale

Intervention groups

1

Description
Participants in the experimental group receive Compassion-Focused Therapy (CFT) based on Gilbert's standard protocol (2009). The intervention consists of 12 weekly sessions, each lasting 90 minutes (total duration: approximately 3 months). Sessions are conducted individually by a PhD student in clinical psychology under the supervision of the supervisor at Taleghani Hospital Psychology Clinic, Tehran.Sessions 1-4: Psychoeducation (evolutionary model of depression, "tricky brain," three-system model: threat, drive, soothing), mindfulness, and rhythmic breathing exercises.Sessions 5-8: Defining compassion (kindness, common humanity, mindfulness), identifying the "inner critic," developing the "compassionate self" through imagery exercises (safe place, compassionate self, compassionate others), and cognitive restructuring with a supportive tone.Sessions 9-10: Identifying shame triggers and self-critical patterns, exploring developmental roots (childhood experiences), addressing fear of compassion, and reducing avoidance behaviors (e.g., perfectionism).Sessions 11-12: Writing a compassionate letter to oneself, reviewing all learned skills, and developing a relapse prevention plan.
Category
Treatment - Other

2

Description
Control group: Participants in the control group receive standard pharmacotherapy under the supervision of a collaborating psychiatrist for approximately 3 months. Based on standard guidelines for major depressive disorder treatment, first-line medications from the SSRI class (Selective Serotonin Reuptake Inhibitors) are prescribed. The type of medication, dosage, and treatment duration are determined by the treating psychiatrist based on clinical judgment and with the aim of achieving medication stability throughout the study period.Common medication options include Sertraline (starting dose: 50 mg/day, titrated up to 200 mg/day if needed) or Escitalopram (starting dose: 10 mg/day, titrated up to 20 mg/day). Prescriptions follow the latest clinical guidelines (e.g., American Psychiatric Association guidelines).Patients are monitored by the psychiatrist for side effects and treatment response throughout the study. The control group does not receive any additional psychological intervention (such as CFT or other psychotherapies) during the study period.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Hassan Khazraei
Street address
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 912 957 6671
Email
hassankhazaraee@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
Arabi Street, Daneshjo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 21 2243 9937
Email
ghazalehazar.8540@gmail.com
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
50
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
Dr. Hassan Khazraei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 21 2303 1548
Email
hassankhazraee@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hassan Khazraei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 21 2303 1548
Email
hassankhazraee@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hassan Khazraei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 21 2303 1548
Email
hassankhazraee@sbmu.ac.ir

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
The data from this study include fMRI brain images and sensitive clinical information from patients with major depressive disorder. Due to the potentially traceable nature of neuroimaging data (even after removal of identifiable features) and ethical commitments to participant confidentiality, sharing de-identified individual participant data is not possible. Furthermore, the original proposal did not include a plan for IPD sharing, and the informed consent form does not cover this option.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Title: Statistical Analysis Plan of the Randomized Clinical Trial of CFT in Major Depression Details: Includes methods for analyzing questionnaire data (SPSS, MANCOVA tests, repeated measures) and methods for preprocessing and analyzing fMRI data (SPM software, CONN toolbox, resting-state functional connectivity analysis).
When the data will become available and for how long
6 months after study completion and primary results publication (estimated late 2027)
To whom data/document is available
All researchers, professors, students, and specialists in clinical psychology, neuroscience, and psychiatry affiliated with accredited academic, research, or medical institutions.
Under which criteria data/document could be used
The study protocol is available for scientific study and citation only. Commercial use or reproduction without source attribution is not permitted. Any use must include full citation of the source (published article or IRCT-registered protocol).
From where data/document is obtainable
Primary contact: Principal investigator – Ms. Ghazaleh Azar Email: ghazalehazar.8540@sbmu.ac.ir Secondary contact: Supervisor – Dr. Hassan Khazraei Email: hassankhazaraee@sbmu.ac.ir Tertiary contact: Taleghani Hospital, Psychology Clinic – Address: Arabi Street, Daneshjo Blvd., Velenjak, Tehran, Iran
What processes are involved for a request to access data/document
Applicant submits a written request along with a letter of introduction from their academic institution to the principal investigator's email. The request will be reviewed within a maximum of 2 business weeks. If approved, the protocol file will be sent to the applicant via email.
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