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IRCT20260616069833N1 IRCT 2026-07-07 Kashan University of Medical Sciences Comparison of the effectiveness of Emotion Efficacy Therapy and Mindfulness-Based Cognitive Therapy in improving symptoms and functioning in women with vaginismus EET-MBCT A Comparison of the Effectiveness of Emotion Efficacy Therapy and Mindfulness-Based Cognitive Therapy on Emotional Symptoms, Psychological Flexibility,Marital Satisfaction, and Sexual Function in Women with Vaginismus 2026-08-23 anticipated 60 Recruiting https://irct.ir/trial/91285 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: The study will be conducted as an open-label trial. However, to minimize bias, the data analyst will be blinded to group allocation, Randomization description: After confirming eligibility and obtaining written informed consent, a unique identification code will be assigned to each participant. A random allocation sequence will then be generated using a random number table, and participants will be randomly assigned in a 1:1:1 allocation ratio to the Emotion Efficacy Therapy group, the Mindfulness-Based Cognitive Therapy group, or the control group. Allocation will be performed according to the pre-generated sequence obtained from the random number table. N/A Vaginismus. Intervention 1: Intervention group: Participants will receive eight weekly 90-minute sessions of Emotion Efficacy Therapy, based on a standardized treatment protocol, in addition to usual treatment. Intervention 2: Intervention group: Participants will receive eight weekly 90-minute sessions of Mindfulness-Based Cognitive Therapy, based on a standardized treatment protocol, in addition to usual treatment. Intervention 3: Control group: Participants will receive usual treatment only, with no additional psychological intervention during the study period. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data will not be shared due to participant confidentiality.
public Monire Artang
No. 4, Fereshteh 3 Alley, Khwarizmi 1 St., Sepahan Shahr, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8179934571 +98 31 3651 6736 mnr.artang@gmail.com Kashan University of Medical Sciences scientific Monire Artang
No. 4, Fereshteh 3 Alley, Khwarizmi 1 St., Sepahan Shahr, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8179934571 +98 31 3651 6736 mnr.artang@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of vaginismus confirmed by a gynecologist or obstetrician. Age between 18 and 45 years. Absence of psychiatric disorders requiring immediate treatment. Absence of other significant physical illnesses. Not receiving any other psychological intervention or psychotherapy concurrently. Provision of written informed consent to participate in the study. Iranian nationality. 18 years 45 years Female Receiving any other educational or therapeutic intervention concurrently. Development of psychiatric disorders during the study that require immediate treatment. Absence from more than two psychotherapy sessions. Incomplete completion of the study questionnaires. Withdrawal of consent to continue participation in the study at any stage of the trial. Use of medications that may affect sexual function. N94.2 Vaginismus Treatment - Other Treatment - Other Treatment - Other Intervention group: Participants will receive eight weekly 90-minute sessions of Emotion Efficacy Therapy, based on a standardized treatment protocol, in addition to usual treatment. Intervention group: Participants will receive eight weekly 90-minute sessions of Mindfulness-Based Cognitive Therapy, based on a standardized treatment protocol, in addition to usual treatment. Control group: Participants will receive usual treatment only, with no additional psychological intervention during the study period. Emotional symptoms score measured by the DASS-21 questionnaire. Timepoint: At baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and 3 months after the completion of the intervention (follow-up). Method of measurement: Depression, Anxiety and Stress Scale, 21-Item Version. Psychological flexibility score measured by the AAQ-II questionnaire. Timepoint: At baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and 3 months after the completion of the intervention (follow-up). Method of measurement: Acceptance and Action Questionnaire, Second Version. Marital satisfaction score measured by the ENRICH Marital Satisfaction Questionnaire. Timepoint: At baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and 3 months after the completion of the intervention (follow-up). Method of measurement: Enrich Marital Satisfaction Questionnaire. Sexual function score measured by the Female Sexual Function Index (FSFI). Timepoint: At baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and 3 months after the completion of the intervention (follow-up). Method of measurement: Female Sexual Function Index. Kashan University of Medical Sciences Approved 2026-06-29 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Physician Blvd., Km 3, Ravand Road, Kashan, Isfahan, Iran Kashan Isfehan Iran (Islamic Republic of)