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

Not Applicable
Completed
Conditions
Epilepsy
Sexual Dysfunction
Interventions
Behavioral: Mindfulness-Based Sex Therapy
Registration Number
NCT03427918
Lead Sponsor
Qazvin University Of Medical Sciences
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
660
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
patient-partnerMindfulness-Based Sex Therapypatients 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.
patient-partner and health care providersMindfulness-Based Sex Therapypatients 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.
Primary Outcome Measures
NameTimeMethod
Sexual functioningchanges from baseline, 1 Months and 6 months

Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)

Intimacychanges from baseline, 1 Months and 6 months

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

sexuality-related distresschanges from baseline, 1 Months and 6 months

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.

Secondary Outcome Measures
NameTimeMethod
Psychological distresschanges from baseline, 1 Months and 6 months

Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations

Marital satisfactionchanges from baseline, 1 Months and 6 months

The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.

Erectile Functionchanges from baseline, 1 Months and 6 months

International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function

quality of lifechanges of QOLIE-31-P from baseline, 1 Months and 6 months

QOLIE-31-P will be used to assess patient's quality of life

Mindfulness for sexual functioningchanges from baseline, 1 Months and 6 months

Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.

Trial Locations

Locations (15)

Abbasi

🇮🇷

Karaj, Iran, Islamic Republic of

Brain and Neuropsychological Clinic

🇮🇷

Karaj, Iran, Islamic Republic of

Lolagar Hospital

🇮🇷

Tehran, Iran, Islamic Republic of

Rasoul Akram Hospital

🇮🇷

Tehran, Iran, Islamic Republic of

Sina

🇮🇷

Tehran, Iran, Islamic Republic of

Razi Hospital

🇮🇷

Qazvin, Iran, Islamic Republic of

Shahid Madani

🇮🇷

Karaj, Iran, Islamic Republic of

Mehregan

🇮🇷

Qazvin, Iran, Islamic Republic of

Shahid Rejaei

🇮🇷

Karaj, Iran, Islamic Republic of

Attar clinic

🇮🇷

Tehran, Iran, Islamic Republic of

Baharlu Hospital

🇮🇷

Tehran, Iran, Islamic Republic of

Sadaf

🇮🇷

Tehran, Iran, Islamic Republic of

Rezaei Clinic

🇮🇷

Tehran, Iran, Islamic Republic of

Raha

🇮🇷

Tehran, Iran, Islamic Republic of

Ziaeian

🇮🇷

Tehran, Iran, Islamic Republic of

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