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

Primary Purpose

Epilepsy, Sexual Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Mindfulness-Based Sex Therapy
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Abbasi
  • Brain and Neuropsychological Clinic
  • Shahid Madani
  • Shahid Rejaei
  • Mehregan
  • Razi Hospital
  • Attar clinic
  • Baharlu Hospital
  • Lolagar Hospital
  • Raha
  • Rasoul Akram Hospital
  • Rezaei Clinic
  • Sadaf
  • Sina
  • Ziaeian

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

patient-partner

patient-partner and health care providers

Control group

Arm Description

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.

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.

The control group will receive a routine counseling

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mindfulness for sexual functioning
Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.
Marital satisfaction
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
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
Erectile Function
International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function
quality of life
QOLIE-31-P will be used to assess patient's quality of life

Full Information

First Posted
December 9, 2017
Last Updated
January 9, 2023
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03427918
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Sexual Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient-partner
Arm Type
Experimental
Arm Description
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.
Arm Title
patient-partner and health care providers
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive a routine counseling
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Sex Therapy
Intervention Description
Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.
Primary Outcome Measure Information:
Title
Sexual functioning
Description
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Time Frame
changes from baseline, 1 Months and 6 months
Title
Intimacy
Description
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
Time Frame
changes from baseline, 1 Months and 6 months
Title
sexuality-related distress
Description
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.
Time Frame
changes from baseline, 1 Months and 6 months
Secondary Outcome Measure Information:
Title
Mindfulness for sexual functioning
Description
Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.
Time Frame
changes from baseline, 1 Months and 6 months
Title
Marital satisfaction
Description
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
Time Frame
changes from baseline, 1 Months and 6 months
Title
Psychological distress
Description
Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations
Time Frame
changes from baseline, 1 Months and 6 months
Title
Erectile Function
Description
International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function
Time Frame
changes from baseline, 1 Months and 6 months
Title
quality of life
Description
QOLIE-31-P will be used to assess patient's quality of life
Time Frame
changes of QOLIE-31-P from baseline, 1 Months and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Abbasi
City
Karaj
Country
Iran, Islamic Republic of
Facility Name
Brain and Neuropsychological Clinic
City
Karaj
Country
Iran, Islamic Republic of
Facility Name
Shahid Madani
City
Karaj
Country
Iran, Islamic Republic of
Facility Name
Shahid Rejaei
City
Karaj
Country
Iran, Islamic Republic of
Facility Name
Mehregan
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Facility Name
Razi Hospital
City
Qazvin
Country
Iran, Islamic Republic of
Facility Name
Attar clinic
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Baharlu Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Lolagar Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Raha
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Rasoul Akram Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Rezaei Clinic
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Sadaf
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Sina
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Ziaeian
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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