Mindfulness as Treatment of Sexological Problems

NCT03775239 | Completed DMC

• 1 other identifier: H-18017600
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Sexual Dysfunctions, Psychological; Sexual Dysfunctions, Physiological

Keywords

Desire dysfunction; Erectile dysfunction; Orgasm dysfunction; Sexual pain; Hyper sexuality; Mindfulness

Outcome Measures

Primary Outcomes (5)

• The Sexual Function Questionnaire for Females & Males (CSFQ-14-F/M)

  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.

  Change from baseline CSFQ score to 6 month follow-up CSFQ score

• Female Sexual Function Index (FSFI)

  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

  Change from baseline FSFI score to 6 month follow-up FSFI score

• Female Sexual Distress Scale (FSDS)

  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.

  Change from baseline FSDS score to 6 month follow-up FSDS score

• The International Index of Erectile Function (IIEF)

  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).

  Change from baseline IIEF score to 6 month follow-up IIEF score

• Bothered by Problem (VAS)

  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?"

  Change from baseline VAS score to 6 month follow-up VAS score

Secondary Outcomes (4)

• The Five Facet Mindfulness Questionnaire (FFMQ)

  1 time a week after mindfulness session up to 8 weeks

• The Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Week 0, week 3,6,9,month 6

• World Health Organization 5 Wellbeing Questionnaire (WHO-5)

  Week 0, week 3,6,9,month 6

• The Symptom Checklist (SCL-10)

  Week 0, week 3,6,9,month 6

Other Outcomes (1)

• Questionnaire to collect individual demographic data

  Week 0 and month 6.

Study Arms (2)

Treatment-as-usual

OTHER

Those who are randomly selected to treatment-as-usual will receive a minimum of 6 sessions at Sexological Clinic.

Behavioral: Treatment-as-usual

Treatment-as-usual + MSIR

OTHER

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); Behavioral: Treatment-as-usual

Interventions

Mindfulness in Sex Therapy and Intimate Relationships (MSIR) BEHAVIORAL

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

Treatment-as-usual + MSIR

Treatment-as-usual BEHAVIORAL

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; Treatment-as-usual + MSIR

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Den Owesenske Fond: collaborator

Study Sites (1)

Sexological Clinic

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: December 13, 2018
• Study Start: July 25, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 19, 2022
• Last Updated: February 3, 2023

Record last verified: 2022-12

Locations

DK (1)