Mindfulness as Treatment of Sexological Problems
Condition: Sexual Dysfunction; Sexual Dysfunctions, Psychological; Sexual Dysfunctions, Physiological
MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Study type: Interventional

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.
    

Intervention name(s): Mindfulness in Sex Therapy and Intimate Relationships (MSIR); Treatment-as-usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness is a mental discipline inviting intentional, non-judgmental attending of the stream of experience. Mindfulness can be seen as an adjunct to sexual therapy. Firstly, it is a way of teaching the patients and the couples to carry out sensate focus so that it can achieve its goals. Beyond this, Mindfulness may invite a stance to one's own and a partner's physical and emotional experience that is more widely beneficial. The MSIR intervention was originally developed from the Mindfulness Based Cognitive Therapy (MBCT) protocol and consists of:
Week 1: Moving into the Body Week 2: Sensing & Exploring Week 3: Avoidance & Intimacy- Midway individual session. Week 4: Recognising our automatic mind Week 5: Spacious Awareness Week 6: Expanding new learning; The current treatment in Sexological Clinic is an eclectic, synthetic therapy form conducted by psychiatrists, other medical doctors, psychologists and bodytherapists.
In order to implement the bio-psycho-social character of sexual dysfunctions, the current treatment takes advantage of different elements from different therapy forms combined with pharmacological treatment if necessary.
The integrated treatment combines elements from therapy's such as cognitive behavioural therapy (CBT), psychodynamic therapy and systemic therapy together with Master and Johnson's sensate focus training, body exercises training as pelvis floor exercises, introduction of sexual aids and if necessary pharmacological treatment. The therapy can be individual treatment, couple therapy (marital therapy) or group therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Desire dysfunction; Erectile dysfunction; Orgasm dysfunction; Sexual pain; Hyper sexuality; Mindfulness