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

NCT ID: NCT03427918

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-03-30

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

Detailed Description

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Conditions

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Epilepsy Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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patient-partner

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.

Group Type EXPERIMENTAL

Mindfulness-Based Sex Therapy

Intervention Type BEHAVIORAL

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

patient-partner and health care providers

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.

Group Type EXPERIMENTAL

Mindfulness-Based Sex Therapy

Intervention Type BEHAVIORAL

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

Control group

The control group will receive a routine counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-Based Sex Therapy

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir H Pakpour

Director of Social Determinants of Health Research Center (SDH)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abbasi

Karaj, , Iran

Site Status

Brain and Neuropsychological Clinic

Karaj, , Iran

Site Status

Shahid Madani

Karaj, , Iran

Site Status

Shahid Rejaei

Karaj, , Iran

Site Status

Mehregan

Qazvin, , Iran

Site Status

Razi Hospital

Qazvin, , Iran

Site Status

Attar clinic

Tehran, , Iran

Site Status

Baharlu Hospital

Tehran, , Iran

Site Status

Lolagar Hospital

Tehran, , Iran

Site Status

Raha

Tehran, , Iran

Site Status

Rasoul Akram Hospital

Tehran, , Iran

Site Status

Rezaei Clinic

Tehran, , Iran

Site Status

Sadaf

Tehran, , Iran

Site Status

Sina

Tehran, , Iran

Site Status

Ziaeian

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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1396.169

Identifier Type: -

Identifier Source: org_study_id

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