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

• Sponsor: Qazvin University Of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03427918
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 71.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Sexual Dysfunction	Behavioral: Mindfulness-Based Sex Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 1, 2017
• Anticipated Primary Completion Date: Apr 1, 2018
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sexual functioning [changes from baseline, 1 Months and 6 months]

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

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

   The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.

3. Psychological distress [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 [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 [changes from baseline, 1 Months and 6 months]

   QOLIE-31-P will be used to assess patient's quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Booali Sina Hospital	Qazvin		Iran, Islamic Republic of	3419759811

Sponsors and Collaborators

• Qazvin University Of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amir H Pakpour, Director of Social Determinants of Health Research Center (SDH), Qazvin University Of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03427918
• Other Study ID Numbers: IR.QUMS.REC.1396.169
• First Posted: Feb 9, 2018
• Last Update Posted: Feb 9, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Feb 9, 2018