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IRCT20260607069694N1 IRCT 2026-07-02 Shahid Beheshti University of Medical Sciences The effect of compassion-focused therapy on functional connectivity of brain networks and psychological symptoms in individuals with major depressive disorder CFT The effect of compassion-focused therapy on functional connectivity of brain networks and psychological symptoms in individuals with major depressive disorder 2026-10-22 anticipated 40 Recruiting https://irct.ir/trial/90755 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Condition 1: Major Depressive Disorder (MDD). Condition 2: Major Depressive Disorder (MDD). Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Dr. Hassan Khazraei
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 4631- 19395. +98 21 2303 1548 hassankhazraee@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Hassan Khazraei
Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 4631- 19395. +98 21 2303 1548 hassankhazraee@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 50 years Both 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. Treatment - Other Treatment - Other 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. 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. 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. 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). Increase in self-compassion score. Timepoint: Before the intervention and after the completion of the intervention. Method of measurement: Self-Compassion Scale (Short Form). Reduction in rumination score. Timepoint: Before the intervention and after the completion of the intervention. Method of measurement: Ruminative Response Scale. Reduction in external shame score. Timepoint: Before the intervention and after the completion of the intervention. Method of measurement: External Shame Scale. 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). 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. Shahid Beheshti University of Medical Sciences Approved 2026-06-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Arabi Street , Daneshjo Boulevard, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)