Mindfulness in sex therapy and intimate relationships: a feasibility and randomized controlled pilot study in a cross-diagnostic group.

Background: Mindfulness facets can be trained with structured mindfulness interventions, but little is known regarding application on a broader level within sex therapy (e.g. men, partners and different sexual dysfunctions). Aim: To evaluate the feasibility and preliminary efficacy of an 8-week intervention-specifically, mindfulness for sex and intimacy in relationships (MSIR)-as a supplement to treatment as usual (TAU) as compared with only TAU in a clinical sample of men and women referred for sexual difficulties with or without a partner. Methods: In this randomized controlled feasibility pilot study, 34 participants were randomized to MSIR + TAU (n = 15) or TAU (n = 19). Six healthy partners were also included in the study. MSIR was administered as 2 individual evaluations and six 2-hour group sessions of mixed gender and different types of sexual dysfunction. Outcomes: The primary outcome measures were as follows: (1) feasibility, defined as the implementation of recruitment, acceptance, and attendance of intervention in daily clinical practice and the MSIR completion rate; (2) sexual functioning, as measured on a visual analog scale ("bothered by problem") and by validated questionnaires (Changes in Sexual Function Questionnaire for Females and Males, Female Sexual Function Index, Female Sexual Distress Scale, International Index of Erectile Function). Results: MSIR was feasible and well received by patients, with high rates of acceptance and intervention completion. As compared with pretreatment, the MSIR + TAU group and TAU control group were significantly less bothered by their sexual problems at the end of treatment, but the change was significantly larger in the MSIR + TAU group (P = .04). Participants in the MSIR + TAU group did not receive fewer TAU sessions than the TAU group (MSIR + TAU mean, 6 sessions; TAU mean, 8 sessions). Clinical Implications: MSIR could be effectively used in a clinical setting as an add-on to TAU in the treatment of female and male sexual dysfunction and healthy partners. Strengths and Limitations: The major strength of the study is that it is a randomized controlled study. This study is novel in the sense that it included men and women with different types of sexual dysfunction in the same mindfulness group. Limitations include the pilot nature of the study (e.g. a small sample size), and statistical conclusions should be made with caution. More accurate results may be found in a larger sample. Conclusion: Results from this study support already existing evidence that mindfulness-based interventions are feasible and effective for targeting sexual dysfunctions in men and women.

Are investigators' access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials.

OBJECTIVES: To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators. METHODS: Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early. RESULTS: The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%). CONCLUSIONS: Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.

Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols.

OBJECTIVE: To investigate to what extent evidence from previous similar trials or systematic reviews was considered before conducting new trials. DESIGN: Cohort study of contemporary protocols for trials with ethical approval. METHODS: All protocols for randomised trials approved by the five ethical committees in Denmark between January 2012 and March 2013 were screened for eligibility. Included protocols were read in full to determine whether a systematic search had been conducted and references were checked to evaluate whether trial rationale and design could be challenged for not adequately considering previous evidence. To investigate whether protocols cited relevant trials, we used simple search strategies that could easily be conducted by researchers without experience with literature searches. RESULTS: Sixty-seven protocols were included. Only two (3%) of the protocols explicitly stated to have conducted a literature search and only one (1%) provided information that allowed the search to be replicated. Eleven (16%) of the protocols described trials where we found the information insufficient to judge if the trial was ethically justified, either due to a comparator that was not supported by the presented evidence (six protocols), because they did not present a rationale for conducting the trial (two protocols), or for both reasons (three protocols). For eight (12%) of the protocols, our search identified trials that could have been relevant to cite as justification. CONCLUSIONS: While most protocols seem to adequately consider existing evidence, a substantial minority of trials might lack a sufficient evidence base. Very few trials seemed to have been based on a literature search which makes it impossible to know whether all relevant previous trials had been considered. Rules for ethical approval should include requirements for systematic literature searches to ensure that research participants are not exposed to sub-optimal treatments or unnecessary harms as well as to reduce research waste.

[Mindfulness in the treatment of sexual difficulties].

In this review, we present the status of mindfulness in the treatment of sexual difficulties in men and women. The prevalence of sexual difficulties is high among both men and women. Sexual difficulties are often associated with somatic and mental disorders, and therefore effective treatments are needed. Growing evidence shows, that standardised mindfulness programmes are effective in the treatment of stress, anxiety, depression and chronic pain. Evidence for mindfulness therapy in sexology is sparse, but results so far suggest, that mindfulness can be effective in sex therapy.

Redactions in protocols for drug trials: what industry sponsors concealed.

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.