NCT03427918

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

December 9, 2017

Last Update Submit

January 9, 2023

Conditions

EpilepsySexual Dysfunction

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Mindfulness for sexual functioning

    changes from baseline, 1 Months and 6 months

  • Marital satisfaction

    changes from baseline, 1 Months and 6 months

  • Psychological distress

    changes from baseline, 1 Months and 6 months

  • Erectile Function

    changes from baseline, 1 Months and 6 months

  • quality of life

    changes of QOLIE-31-P from baseline, 1 Months and 6 months

Study Arms (3)

patient-partner

EXPERIMENTAL

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

patient-partner and health care providers

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will receive a routine counseling

Interventions

Mindfulness-Based Sex TherapyBEHAVIORAL

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

patient-partnerpatient-partner and health care providers

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Abbasi

Karaj, Iran

Location

Brain and Neuropsychological Clinic

Karaj, Iran

Location

Shahid Madani

Karaj, Iran

Location

Shahid Rejaei

Karaj, Iran

Location

Mehregan

Qazvin, 3419759811, Iran

Location

Razi Hospital

Qazvin, Iran

Location

Attar clinic

Tehran, Iran

Location

Baharlu Hospital

Tehran, Iran

Location

Lolagar Hospital

Tehran, Iran

Location

Raha

Tehran, Iran

Location

Rasoul Akram Hospital

Tehran, Iran

Location

Rezaei Clinic

Tehran, Iran

Location

Sadaf

Tehran, Iran

Location

Sina

Tehran, Iran

Location

Ziaeian

Tehran, Iran

Location

MeSH Terms

Conditions

EpilepsySexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Social Determinants of Health Research Center (SDH)

Study Record Dates

First Submitted

December 9, 2017

First Posted

February 9, 2018

Study Start

February 1, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

IR(15)