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Mindfulness as Treatment of Sexological Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775239
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Den Owesenske Fond
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

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.


Condition or disease Intervention/treatment Phase
Sexual Dysfunction Sexual Dysfunctions, Psychological Sexual Dysfunctions, Physiological Behavioral: Mindfulness in Sex Therapy and Intimate Relationships (MSIR) Behavioral: Treatment-as-usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Treatment-as-usual
Those who are randomly selected to treatment-as-usual will receive a minimum of 6 sessions at Sexological Clinic.
Behavioral: Treatment-as-usual

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.


Treatment-as-usual + MSIR
Those who are randomly selected to receive Mindfulness in Sex Therapy and Intimate Relationships (MSIR) will first receive 6 weeks of mindfulness followed by treatment-as-usual. The intervention will take place at Sexological Clinic.
Behavioral: Mindfulness in Sex Therapy and Intimate Relationships (MSIR)

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


Behavioral: Treatment-as-usual

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.





Primary Outcome Measures :
  1. The Sexual Function Questionnaire for Females & Males (CSFQ-14-F/M) [ Time Frame: Change from baseline CSFQ score to 6 month follow-up CSFQ score ]
    The CSFQ is a 14 item self-report inventory which measures sexual functioning on a 5 point likert scale. The questionnaire comprises: a 5 scale structure consistent with the original (longer) CSFQ - Desire/Frequency, Desire/Interest, Arousal/Excitement, Orgasm/Completion, Pleasure, The questionnaire has a high degree of internal consistency as a whole (Cronbach's alpha = 0.90 for females and 0.89 for males) and for the individual scales (all were between 0.68 and 0.84, except the male orgasm/completion scale, 0.59). Good scale coherency and discrimination was demonstrated by highly significant mean difference scores between the CSFQ and control groups.

  2. Female Sexual Function Index (FSFI) [ Time Frame: Change from baseline FSFI score to 6 month follow-up FSFI score ]
    The Female Sexual Function Index (FSFI) is a validated 19-item multidimensional self-report instrument for the assessment of female sexual function that comprise a full scale and six subscales (desire, arousal, lubrication, orgasm, satisfaction and pain). It measures the overall sexual function through either 0-5 or 1-5-point Likert scales. A higher score represents better sexual function. A score equal to or below 26.55 points represents a risk of sexual dysfunction. The FSFI has shown test-retest reliability (r=0,75-0,86). The scale is recommended for clinical practice as a measure of symptoms severity in women who have been sexually active in the prior 4 weeks51 and is the golden standard when measuring sexual function in women

  3. Female Sexual Distress Scale (FSDS) [ Time Frame: Change from baseline FSDS score to 6 month follow-up FSDS score ]
    The Female Sexual Distress Scale (FSDS) is a validated 12-item self-administered questionnaire, developed to measure sexually related personal distress in women. Lower scores represent less sexual distress. Scores equal to or above 15 points indicates sexually related distress.

  4. The International Index of Erectile Function (IIEF) [ Time Frame: Change from baseline IIEF score to 6 month follow-up IIEF score ]
    The IIEF is a validated self-administered 15-item questionnaire that asses male sexual function. The IIEF-questionnaire seeks to detect treatment-related changes in patients with erectile functions and is the golden standard. The IIEF comprises a full scale and five subdomains (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). A low score represents worse sexual function. The questionnaire comprises a full scale and five subdomains. The subdomains are; erectile function; orgasmic function; sexual desire; intercourse satisfaction; and overall satisfaction).

  5. Bothered by Problem (VAS) [ Time Frame: Change from baseline VAS score to 6 month follow-up VAS score ]
    Single-item distress scale measuring on a Likert scale from 1-10 (10 is most distressed) distress by the problem which the person sought help for. "How bothered are you at this time of the problem you are/were seeking for help for?"


Secondary Outcome Measures :
  1. The Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 1 time a week after mindfulness session up to 8 weeks ]
    The FFMQ is a 39-item selfreport scale that measures levels of dispositional mindfulness in everyday life across the five facets: observing, describing, acting with awareness, non-judging and non-reactivity.

  2. The Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: Week 0, week 3,6,9,month 6 ]
    The MAIA is a self-report public domain questionnaire developed. It is a 32-item multidimensional instrument that assesses eight concepts. The scale has been confirmed as a valuable source in understanding clinical outcomes, as the MAIA is concerned with understanding a large scope of medical and psychological conditions.

  3. World Health Organization 5 Wellbeing Questionnaire (WHO-5) [ Time Frame: Week 0, week 3,6,9,month 6 ]
    The WHO-5 is a self-administered 5 item questionnaire assessing the degree of positive well-being during the past 2 weeks on a six-point Likert scale graded from 0 (at no time) to 5 (all of the time), and the total score ranges from 0 to 25, with high scores indicating an increased sense of well-being. It has been shown to have good internal reliability (Cronbach's Alpha = 0.89), external concurrent validity and discriminatory validity as a screening tool for depression (p<0.001) in older people, diabetic patients and a general outpatient sample.

  4. The Symptom Checklist (SCL-10) [ Time Frame: Week 0, week 3,6,9,month 6 ]
    The SCL-10 is a brief version developed from the SCL-90 questionnaire that measures mental or affective distress. The SCL-10 is well validated to measure psychological distress. The SCL-10 has been translated into Danish and is routinely used when measuring the effect of psychotherapeutic intervention. The questionnaire uses a 5-point Likert scale rate ranging from 0 (not at all) to 4 (extremely) and measures the past two weeks.


Other Outcome Measures:
  1. Questionnaire to collect individual demographic data [ Time Frame: Week 0 and month 6. ]
    The demographic questionnaire will entail questions concerning date of birth, gender, relationship status, medication, education and occupation. These demographic questions can through statistical analysis help us identify a potential pattern of who is more susceptible for treatment and if there are any correlations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775239


Locations
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Denmark
Sexological Clinic
Copenhagen, Denmark, 2200
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Den Owesenske Fond
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Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03775239    
Other Study ID Numbers: H-18017600
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mental Health Services in the Capital Region, Denmark:
Desire dysfunction
Erectile dysfunction
Orgasm dysfunction
Sexual pain
Hyper sexuality
Mindfulness
Additional relevant MeSH terms:
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Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders