Clinical trial NCT03775239: Mindfulness as Treatment of Sexological Problems
Official title: Mindfulness as Treatment of Sexological Problems: A Randomized, Controlled Pilot Study of Mindfulness in Sex Therapy and Intimate Relationships (MSIR) in the Treatment of Sexual Dysfunctions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Sexual Dysfunctions, Psychological
Sexual Dysfunctions, Physiological
Keywords: Desire dysfunction
Erectile dysfunction
Orgasm dysfunction
Sexual pain
Hyper sexuality
Mindfulness
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Den Owesenske Fond
First posted: 2018-12-13
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: BACKGROUND:

Prevalence of sexual dysfunction is high, although estimates are variable. For men, the reported level of sexual difficulty, taking all conditions into account, is around 33% or up to 46%. For women, the reported level of sexual difficulty is higher, with estimates up to around 66%. Sexual dysfunctions are associated with a negative impact on the quality of life in both men and women and there is therefore a need for effective treatments.

AIM:

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

METHODS:

The present study will take form as a feasibility study and is seen as a pilot study which will provide a view on MSIR's effectiveness in the natural environment of Sexological Clinic, Psychiatric Centre Copenhagen.

The research project outlines a pragmatic randomized control trial to evaluate MSIR treatment as an add-on to the treatment-as-usual (TAU) compared to TAU for male and female sexual difficulties. The participants will be drawn from Sexological Clinic's patients referred with sexual problems as decreased desire, erectile dysfunction, orgasmic/ejaculatory dysfunction or hypersexuality.

30 patients will be included; 15 in the MSIR group and 15 as controls. The investigators aim for an equal number of men and women in each group. To follow the methodology of a pragmatic design, the inclusion and exclusion criteria will be kept at a minimum.

MEASURES:

Validated questionnaires will measure the main dependent variables: sexual functioning (FSFI, FSDS, IIEF), mindfulness (TMS, MAIA, FFMQ) and number of sessions of treatment completed. Descriptive variables are SCL-10, well-being (WHO-5) and sociodemographic questionnaire. The questionnaires will be handed out before the beginning of the treatment, after 3 sessions, after 6 sessions, after 9 sessions, in the end of the treatment and then after 6 months of follow-up.

STATISTICS:

Baseline characteristics of the two groups will be compared as appropriate, using independent samples t-test for continuous variables, Kruskal-Wallis and chi-square for categorical variables. The second step is calculating the effect size for change in each dimension for each group using Cohens' d. The statistically significant level p \< 0.05 (two sides) will be used.

ETHICAL CONSIDERATIONS:

The trial is approved by the Regional Ethics Committee in the Capital Region of Denmark and the Danish Data Protection agency.

Eligibility criteria: 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

Primary outcomes:
measure: The Sexual Function Questionnaire for Females & Males (CSFQ-14-F/M)
timeFrame: Change from baseline CSFQ score to 6 month follow-up CSFQ score
measure: Female Sexual Function Index (FSFI)
timeFrame: Change from baseline FSFI score to 6 month follow-up FSFI score
measure: Female Sexual Distress Scale (FSDS)
timeFrame: Change from baseline FSDS score to 6 month follow-up FSDS score
measure: The International Index of Erectile Function (IIEF)
timeFrame: Change from baseline IIEF score to 6 month follow-up IIEF score
measure: Bothered by Problem (VAS)
timeFrame: Change from baseline VAS score to 6 month follow-up VAS score
Secondary outcomes:
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 1 time a week after mindfulness session up to 8 weeks
measure: The Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Week 0, week 3,6,9,month 6
measure: World Health Organization 5 Wellbeing Questionnaire (WHO-5)
timeFrame: Week 0, week 3,6,9,month 6
measure: The Symptom Checklist (SCL-10)
timeFrame: Week 0, week 3,6,9,month 6
Other outcomes:
measure: Questionnaire to collect individual demographic data
timeFrame: Week 0 and month 6.
Locations:
city: Copenhagen
country: Denmark
facility: Sexological Clinic
Study officials:
References: