Sexual DysfunctionNCT03775239
Mindfulness as Treatment of Sexological Problems
A study testing Mindfulness in Sex Therapy and Intimate Relationships (MSIR) and Treatment-as-usual in people with Sexual Dysfunction and Sexual Dysfunctions, Psychological, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sexual Dysfunction, Sexual Dysfunctions, Psychological, Sexual Dysfunctions, Physiological
- What is being tested?
- Mindfulness in Sex Therapy and Intimate Relationships (MSIR) and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jul 2018to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Sexual Dysfunction, Sexual Dysfunctions, Psychological, Sexual Dysfunctions, Physiological
- Being tested
- Mindfulness in Sex Therapy and Intimate Relationships (MSIR), Treatment-as-usual
- Keywords
- Desire dysfunction, Erectile dysfunction, Orgasm dysfunction, Sexual pain, Hyper sexuality, Mindfulness
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness in Sex Therapy and Intimate Relationships (MSIR)Behavioural
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-usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | Other | Those who are randomly selected to treatment-as-usual will receive a minimum of 6 sessions at Sexological Clinic. Receives: 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. Receives: Behavioral: Mindfulness in Sex Therapy and Intimate Relationships (MSIR); Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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?"
Measured: Change from baseline VAS score to 6 month follow-up VAS score
Secondary outcomes (4)
The Five Facet Mindfulness Questionnaire (FFMQ)
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.
Measured: 1 time a week after mindfulness session up to 8 weeks
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
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.
Measured: Week 0, week 3,6,9,month 6
World Health Organization 5 Wellbeing Questionnaire (WHO-5)
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.
Measured: Week 0, week 3,6,9,month 6
The Symptom Checklist (SCL-10)
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.
Measured: Week 0, week 3,6,9,month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start25 Jul 2018
- Primary completion1 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Den Owesenske Fond
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775239
- Sponsor's protocol ID
- H-18017600
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2018
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03775239
- Acronym / sponsor ID
- H-18017600
- Conditions
- Sexual Dysfunction, Sexual Dysfunctions, Psychological, Sexual Dysfunctions, Physiological
- Keywords
- Desire dysfunction, Erectile dysfunction, Orgasm dysfunction, Sexual pain, Hyper sexuality, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Den Owesenske Fond
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | Other | Behavioral: Treatment-as-usualThose who are randomly selected to treatment-as-usual will receive a minimum of 6 sessions at Sexological Clinic. |
| Treatment-as-usual + MSIR | Other | Behavioral: Mindfulness in Sex Therapy and Intimate Relationships (MSIR), Behavioral: Treatment-as-usualThose 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Treatment-as-usual + MSIR |
| Treatment-as-usualThe 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. | Behavioural | Treatment-as-usual, Treatment-as-usual + MSIR |
Primary outcome
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.
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
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.
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).
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?"
4 secondary outcomes
The Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 1 time a week after mindfulness session up to 8 weeks
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Week 0, week 3,6,9,month 6
World Health Organization 5 Wellbeing Questionnaire (WHO-5)
Time frame: Week 0, week 3,6,9,month 6
The Symptom Checklist (SCL-10)
Time frame: Week 0, week 3,6,9,month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in Sex Therapy and Intimate Relationships (MSIR) and Treatment-as-usual in people with Sexual Dysfunction and Sexual Dysfunctions, Psychological, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.