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Completed

NCT Number: NCT03427918

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Genital Diseases Nervous System Diseases Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abbasi, Karaj, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Sex Therapy

Behavioral

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

Primary outcomes

  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 outcomes

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

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

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2018
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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