CompletedNot Applicable

Mindfulness as Treatment of Sexological Problems

Denmark34 participantsStarted 2018-07-25

Plain-language summary

The primary aim of this study is to test Mindfulness in Sex Therapy and Intimate Relationships (MSIR) as an add-on treatment to sex therapy in a clinical sample of patients referred with sexual problems, controlling for time effect, with a treatment as usual activity group. The secondary aim is to investigate the effect of MSIR alone on sexual dysfunction compared to treatment-as-usual (TAU). It is hypothesized that the MSIR group, in preceding the usual TAU intervention, will achieve greater benefits in relation to sexual functioning outcomes as measured by subjective and objective measures. The investigators expect that MSIR will help the patients to cultivate accept and body awareness, which will create a wider sense of safety and stability that might help integrating the assistant provided by the traditional approach to the treatment of sexual dysfunctions. It is hypothesized that the intervention (MSIR+TAU) reduces the amount of TAU sessions needed in order to achieve a benefit in terms of the patient's sexual dysfunction. It is furthermore, hypothesized that the intervention (MSIR) alone will have a positive effect on the sexual dysfunction. The research project outlines a pragmatic pilot randomized control trial to evaluate MSIR treatment as an add-on to the treatment-as-usual (TAU) compared to TAU for sexual difficulties in men and women.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients aged 20-65 years referred to Sexological Clinic and diagnosed with sexual dysfunction (desire dysfunction, erectile dysfunction, orgasm dysfunction, sexual pain or hyper sexuality). * After assessment, being allocated to individual or couple therapy for their sexual dysfunction. The partner will be included in case of couples therapy * Allocated to a minimum of 6 treatment sessions in TAU after assessment * Giving informed consent * Being able to read, write, speak and understand the Danish language. Exclusion Criteria: * Assessed for group therapy * Cannot participate at the scheduled MSIR session due for practical reasons * Having experienced sexual trauma in the past, suffering from mental illness, severe somatic disease and/or addiction * Withdrawing their informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Sexual Function Questionnaire for Females & Males (CSFQ-14-F/M)

Timeframe: Change from baseline CSFQ score to 6 month follow-up CSFQ score

Female Sexual Function Index (FSFI)

Timeframe: Change from baseline FSFI score to 6 month follow-up FSFI score

Female Sexual Distress Scale (FSDS)

Timeframe: Change from baseline FSDS score to 6 month follow-up FSDS score

The International Index of Erectile Function (IIEF)

Timeframe: Change from baseline IIEF score to 6 month follow-up IIEF score

Bothered by Problem (VAS)

Timeframe: Change from baseline VAS score to 6 month follow-up VAS score

Trial details

NCT IDNCT03775239

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Sexual Dysfunction trials