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

Study Overview
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Brief Summary
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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

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

Conditions
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Epilepsy, Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Mindfulness-Based Sex Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient-partner<br>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<br>* Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.<br>|
| Experimental: patient-partner and health care providers<br>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<br>* Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.<br>|
| No Intervention: Control group<br>The control group will receive a routine counseling | |

What is the study measuring?
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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 |