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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427918
• Other study ID #: 1396.169
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: January 2023
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Sexual Dysfunction

Intervention

Behavioral:
• Mindfulness-Based Sex Therapy
Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.

Locations

Country	Name	City	State
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	Karaj
Iran, Islamic Republic of	Mehregan	Qazvin
Iran, Islamic Republic of	Razi Hospital	Qazvin
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	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual functioning	Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)	changes from baseline, 1 Months and 6 months
Primary	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
Primary	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	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
Secondary	Marital satisfaction	The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.	changes from baseline, 1 Months and 6 months
Secondary	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
Secondary	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
Secondary	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