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 range20 Years – 65 Years

SexALL

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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

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