Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.</p> <p>Methods</p> <p>The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability.</p> <p>Discussion</p> <p>The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN43218782</p

Motivation and treatment engagement intervention trial (MotivaTe-IT): The effects of motivation feedback to clinicians on treatment engagement in patients with severe mental illness

Background: Treatment disengagement and non-completion poses a major problem for the successful treatment of patients with severe mental illness. Motivation for treatment has long been proposed as a major determinant of treatment engagement, but exact mechanisms remain unclear. This current study serves three purposes: 1) to determine whether a feedback intervention based on the patients' motivation for treatment is effective at improving treatment engagement (TE) of severe mentally ill patients in outpatient psychiatric treatment, 2) to gather insight into motivational processes and pos

Lack of Efficacy of Suvorexant in People with Insomnia and Poorly Controlled Type 2 Diabetes

John W Winkelman,1,2 Benjamin Wipper,2 Jordana Zackon,1 Bettina B Hoeppner1 1Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; 2Harvard Medical School, Boston, MA, USACorrespondence: John W Winkelman, Email [email protected]/Background: Sleep disturbance is a common and underappreciated feature of diabetes and sleep may contribute to glycemic control in people with type 2 diabetes (T2D). We conducted a 3-month trial to examine the efficacy of suvorexant in improving sleep and health outcomes in people with suboptimally controlled T2D and insomnia.Participants/Methods: This parallel, double-blind, randomized placebo-controlled trial was conducted using the sequential parallel comparison design (SPCD). Sixty-nine people with poorly controlled T2D (HbA1c ≥ 6.5) were randomized to placebo and/or suvorexant (10– 20 mg). The primary outcome was subjective total sleep time (sTST), and secondary outcomes were Insomnia Severity Index (ISI) score and wake time after sleep onset (WASO). Exploratory outcomes included sleep efficiency, hemoglobin A1c (HbA1c), and C-reactive protein (CRP). Exploratory analyses were conducted on relationships between sleep and diabetes outcomes.Results: There were no significant improvements in sTST (p = 0.27), ISI (p = 0.86), or WASO (p = 0.94) among participants taking suvorexant compared to placebo. There were also no significant changes in any of the exploratory endpoints. Improvements in sleep were associated with improvements in both objective (ie, HbA1c) and subjective (ie, Diabetes Distress Scale) measures of diabetes, as well as reductions in depressive symptoms, independent of treatment assignment.Conclusion: The study did not find evidence that suvorexant is efficacious for insomnia in people with poorly controlled T2D. The associations of improved sleep with improvements in both diabetes-related metrics and depressive symptoms across groups highlight the importance of identifying and treating sleeping difficulties in this population.CT Registration &num;: Nct03818581.Keywords: insomnia, type 2 diabetes, sleep disorders, suvorexan