Clinical trial NCT03427918: The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
Official title: The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Sexual Dysfunction
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 660
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Sexual functioning
timeFrame: changes from baseline, 1 Months and 6 months
measure: Intimacy
timeFrame: changes from baseline, 1 Months and 6 months
measure: sexuality-related distress
timeFrame: changes from baseline, 1 Months and 6 months
Secondary outcomes:
measure: Mindfulness for sexual functioning
timeFrame: changes from baseline, 1 Months and 6 months
measure: Marital satisfaction
timeFrame: changes from baseline, 1 Months and 6 months
measure: Psychological distress
timeFrame: changes from baseline, 1 Months and 6 months
measure: Erectile Function
timeFrame: changes from baseline, 1 Months and 6 months
measure: quality of life
timeFrame: changes of QOLIE-31-P from baseline, 1 Months and 6 months
Other outcomes:
Locations:
city: Karaj
country: Iran, Islamic Republic of
facility: Abbasi
city: Karaj
country: Iran, Islamic Republic of
facility: Brain and Neuropsychological Clinic
city: Karaj
country: Iran, Islamic Republic of
facility: Shahid Madani
city: Karaj
country: Iran, Islamic Republic of
facility: Shahid Rejaei
city: Qazvin
country: Iran, Islamic Republic of
facility: Mehregan
city: Qazvin
country: Iran, Islamic Republic of
facility: Razi Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Attar clinic
city: Tehran
country: Iran, Islamic Republic of
facility: Baharlu Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Lolagar Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Raha
city: Tehran
country: Iran, Islamic Republic of
facility: Rasoul Akram Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Rezaei Clinic
city: Tehran
country: Iran, Islamic Republic of
facility: Sadaf
city: Tehran
country: Iran, Islamic Republic of
facility: Sina
city: Tehran
country: Iran, Islamic Republic of
facility: Ziaeian
Study officials:
References: