The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women

Female sexual dysfunction (FSD) includes impairments in sexual desire, arousal, orgasm, and genital pain resulting in significant subjective distress. This study is aimed to assess a mindfulness-based intervention for improving sexual functioning among women with epilepsy

Study Overview

• Status: Completed
• Conditions: Epilepsy; Sexual Dysfunction
• Intervention / Treatment: Behavioral: Mindfulness-Based Sex Therapy

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Karaj, Iran, Islamic Republic of
    • Abbasi
  • Karaj, Iran, Islamic Republic of
    • Brain and Neuropsychological Clinic
  • Karaj, Iran, Islamic Republic of
    • Shahid Madani
  • Karaj, Iran, Islamic Republic of
    • Shahid Rejaei
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Mehregan
  • Qazvin, Iran, Islamic Republic of
    • Razi hospital
  • Tehran, Iran, Islamic Republic of
    • Attar clinic
  • Tehran, Iran, Islamic Republic of
    • Baharlu Hospital
  • Tehran, Iran, Islamic Republic of
    • Lolagar Hospital
  • Tehran, Iran, Islamic Republic of
    • Raha
  • Tehran, Iran, Islamic Republic of
    • Rasoul Akram Hospital
  • Tehran, Iran, Islamic Republic of
    • Rezaei Clinic
  • Tehran, Iran, Islamic Republic of
    • Sadaf
  • Tehran, Iran, Islamic Republic of
    • Sina
  • Tehran, Iran, Islamic Republic of
    • Ziaeian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Aged 65 years or older
• Female sexual dysfunctions are categorized by the DSM-5 as sexual interest/arousal disorder, genitopelvic pain/penetration disorder, and female orgasmic disorder. The diagnoses require symptoms to be present for six months or more,
• Currently in a relationship that has lasted longer than 1 year
• Both members of the couple are able to speak and read Persian
• Both members of the couple provide signed and dated informed consent form

Exclusion Criteria:

• Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program
• Major psychiatric disorder (e.g., psychosis, personality disorder)
• Current suicidal ideation or suicide attempt within past 3 months
• Past participation in an MBCT program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient-partner; patients and their partners will receive a weekly Mindfulness-Based Sex Therapy program. The treatments will deliver by a group of facilitators to groups of women consisting of 4-7 women.	Behavioral: Mindfulness-Based Sex Therapy; Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.
Experimental: patient-partner and health care providers; patients and their partners as well as health care providers will receive a weekly Mindfulness-Based Sex Therapy program. Th treatments will deliver by a group of facilitators to groups of women consisting of 4-7 women.	Behavioral: Mindfulness-Based Sex Therapy; Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.
No Intervention: Control group; The control group will receive a routine counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual functioning	Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)	changes from baseline, 1 Months and 6 months
Intimacy	Personal Assessment of Intimacy in Relationships (PAIR) will use to assess relationship satisfaction. The PAIR is a self-reported measure with 36 items which cover five subscales	changes from baseline, 1 Months and 6 months
sexuality-related distress	The Female Sexual Distress Scale revised version (FSDS-R) is extensively validated and among the most widely used tools to measure sexually related personal distress.	changes from baseline, 1 Months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness for sexual functioning	Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.	changes from baseline, 1 Months and 6 months
Marital satisfaction	The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.	changes from baseline, 1 Months and 6 months
Psychological distress	Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations	changes from baseline, 1 Months and 6 months
Erectile Function	International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function	changes from baseline, 1 Months and 6 months
quality of life	QOLIE-31-P will be used to assess patient's quality of life	changes of QOLIE-31-P from baseline, 1 Months and 6 months

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: December 9, 2017
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 1396.169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No