Mindfulness as Treatment of Sexological Problems

Sexual Dysfunction Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Sexual Dysfunction
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Physiological
• Sexual Dysfunctions, Psychological

• NCT number: NCT03775239
• Study type: Interventional
• Source: Mental Health Services in the Capital Region, Denmark
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Completion date: December 19, 2022