EpilepsyNCT03427918
The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
A study testing Mindfulness-Based Sex Therapy in people with Epilepsy and Sexual Dysfunction, run by Qazvin University Of Medical Sciences at 15 sites in Iran.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Epilepsy, Sexual Dysfunction
- What is being tested?
- Mindfulness-Based Sex Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 15 sitesIran
- Study dates
- 1 Feb 2018to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Iran15 sites
Abbasi
Karaj
Brain and Neuropsychological Clinic
Karaj
Shahid Madani
Karaj
Shahid Rejaei
Karaj
Mehregan
Qazvin, 3419759811
Razi Hospital
Qazvin
Attar clinic
Tehran
Baharlu Hospital
Tehran
Lolagar Hospital
Tehran
Raha
Tehran
Rasoul Akram Hospital
Tehran
Rezaei Clinic
Tehran
Sadaf
Tehran
Sina
Tehran
Ziaeian
Tehran
About this study
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
- Conditions
- Epilepsy, Sexual Dysfunction
- Being tested
- Mindfulness-Based Sex Therapy
- Medical subject headings
- Epilepsy, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Sex TherapyBehavioural
Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness-Based Sex Therapy |
| Control group | No intervention | The control group will receive a routine counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual functioning
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Measured: 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
Measured: 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.
Measured: changes from baseline, 1 Months and 6 months
Secondary outcomes (5)
Mindfulness for sexual functioning
Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.
Measured: changes from baseline, 1 Months and 6 months
Marital satisfaction
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
Measured: changes from baseline, 1 Months and 6 months
Psychological distress
Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations
Measured: changes from baseline, 1 Months and 6 months
Erectile Function
International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function
Measured: changes from baseline, 1 Months and 6 months
quality of life
QOLIE-31-P will be used to assess patient's quality of life
Measured: changes of QOLIE-31-P from baseline, 1 Months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Feb 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427918
- Sponsor's protocol ID
- 1396.169
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2017
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
- ClinicalTrials.gov ID
- NCT03427918
- Acronym / sponsor ID
- 1396.169
- Conditions
- Epilepsy, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient-partner | Experimental | Behavioral: Mindfulness-Based Sex Therapypatients 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. |
| patient-partner and health care providers | Experimental | Behavioral: Mindfulness-Based Sex Therapypatients 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. |
| Control group | No intervention | –The control group will receive a routine counseling |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Sex TherapyMindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills. | Behavioural | patient-partner, patient-partner and health care providers |
Primary outcome
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)
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
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.
5 secondary outcomes
Mindfulness for sexual functioning
Time frame: changes from baseline, 1 Months and 6 months
Marital satisfaction
Time frame: changes from baseline, 1 Months and 6 months
Psychological distress
Time frame: changes from baseline, 1 Months and 6 months
Erectile Function
Time frame: changes from baseline, 1 Months and 6 months
quality of life
Time frame: changes of QOLIE-31-P from baseline, 1 Months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Sex Therapy in people with Epilepsy and Sexual Dysfunction, run by Qazvin University Of Medical Sciences at 15 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual functioning (time frame: changes from baseline, 1 Months and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.