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

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ClinicalTrials.gov Identifier: NCT03427918
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Amir H Pakpour, Qazvin University Of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Epilepsy Sexual Dysfunction Behavioral: Mindfulness-Based Sex Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 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.
Behavioral: Mindfulness-Based Sex Therapy
Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.

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

No Intervention: Control group
The control group will receive a routine counseling



Primary Outcome Measures :
  1. Sexual functioning [ Time Frame: changes from baseline, 1 Months and 6 months ]
    Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)

  2. Intimacy [ Time Frame: changes from baseline, 1 Months and 6 months ]
    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

  3. sexuality-related distress [ Time Frame: changes from baseline, 1 Months and 6 months ]
    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 :
  1. Mindfulness for sexual functioning [ Time Frame: changes from baseline, 1 Months and 6 months ]
    Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.

  2. Marital satisfaction [ Time Frame: changes from baseline, 1 Months and 6 months ]
    The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.

  3. Psychological distress [ Time Frame: changes from baseline, 1 Months and 6 months ]
    Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations

  4. Erectile Function [ Time Frame: changes from baseline, 1 Months and 6 months ]
    International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function

  5. quality of life [ Time Frame: changes from baseline, 1 Months and 6 months ]
    QOLIE-31-P will be used to assess patient's quality of life



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427918


Contacts
Contact: Amir Pakpour, Ph.D. +98-28-33239259 pakpour_amir@yahoo.com

Locations
Iran, Islamic Republic of
Booali Sina Hospital Recruiting
Qazvin, Iran, Islamic Republic of, 3419759811
Contact: Amir Pakpour, Ph.D.    +98-28-33239259    pakpour_amir@yahoo.com   
Sponsors and Collaborators
Qazvin University Of Medical Sciences

Responsible Party: Amir H Pakpour, Director of Social Determinants of Health Research Center (SDH), Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT03427918     History of Changes
Other Study ID Numbers: IR.QUMS.REC.1396.169
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No