A pilot study to assess the feasibility and impact of a brief motivational intervention on problem drug and alcohol use in adult mental health inpatient units: study protocol for a randomized controlled trial

Abstract

BackgroundSubstance misuse in those with severe mental health problems is common and associated with poor engagement in treatment and treatment outcomes. Up to 44% of those admitted into psychiatric inpatient facilities have coexisting substance-misuse problems. However, this is not routinely addressed as part of their treatment plan. A mental health admission may present a window of opportunity for inpatients to reevaluate the impact of their substance use. This study will aim to evaluate the effectiveness of a targeted brief motivational intervention in improving engagement in treatment and to assess how feasible and acceptable this intervention is to inpatients and staff as a routine intervention.Methods/DesignThis randomized controlled trial will use concealed randomization; blind, independent assessment of outcome at 3 months; characterization of refusers and dropouts; and be analyzed according to the intention-to-treat principle. After baseline assessments, eligible participants will be randomized either to the Brief Integrated Motivational Intervention plus Treatment As Usual, or Treatment as Usual alone. Eligible participants will be those who are new admissions; >18 years; ICD-10 diagnosis of -schizophrenia or related disorder, bipolar affective disorder, recurrent depressive disorder, and DSM-IV diagnosis of substance abuse or dependence over the last 3 months. The primary outcome is engagement in treatment for substance misuse, and secondary outcomes include readiness to change substance misuse together with a cost-effectiveness analysis. Qualitative interviews with staff and participants will assess the acceptability of the intervention.DiscussionThis pilot randomized trial will provide the first robust evidence base for inpatient care of people with severe mental health problems and co-morbid substance misuse and provide the groundwork for confirmatory trials to evaluate a potentially feasible, cost-effective, and easy-to-implement treatment option that may be readily integrated into standard inpatient and community-based care.Trial registrationISRCTN43548483 Date of ISRCTN assignation: 4/17/2014.

Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

“…An embedded qualitative study will explore the acceptability of the ABPI for participants and physiotherapists, and to explore how trial procedures and processes worked in practice. 41 The qualitative study will employ two methods, namely semistructured individual interviews for physiotherapists and a focus group for participants from phase I. Potential participants in either method will be invited via email including an attached participant information sheet and consent form.…”

“…All physiotherapists who deliver the ABPI (3–4 physiotherapists) will be invited to an individual face-to-face interview by the lead researcher (TW) using a semistructure interview technique. 41 43 Each interview, which will take ∼60 min and take place at physiotherapists' clinics, will explore the opinions about attitudes towards and acceptance of the ABPI in managing acute WADII. Furthermore, perceptions of the similarities and differences between standard physiotherapy and the ABPI will be examined.…”

Pilot randomised trial of a brief intervention for comorbid substance misuse in psychiatric in‐patient settings

“…The study was an open (rater blinded), prospective randomised trial, analysed by intention to treat . Intention to treat according to ICH E9 is the principle that participants are analysed on the basis of the group to which they were randomised regardless of the treatment that they actually received.…”

“…Total service costs were compared at baseline and over the postrandomisation period, the latter adjusting for the baseline costs. The EQ‐5D measure was used, which is frequently used to produce quality‐adjusted life years as part of economic evaluations . Cost data are frequently skewed, and a bootstrap model was used which makes no assumption about the underlying cost distribution.…”

Mental Health Hospital Admissions: a Teachable Moment and Window of Opportunity To Promote Change in Drug and Alcohol Misuse

“…Of the 59 participants (BIMI = 30, TAU = 29) who gave informed consent to participate in the feasibility RCT, 21 participants in the treatment group (BIMI plus treatment as usual) agreed to complete a semi-structured qualitative interview at the three-month follow-up point. See Graham et al (2014Graham et al ( , 2016b for a full description of the wider study methodology. The trial was funded by the National Institute for Health ResearchResearch for Patient Benefit and received ethical approval from the West MidlandsThe Black Country National Research Ethics Committee (12WM/0369) and was registered with Current Controlled Trials (ISRCTN43584883).…”