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A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

ABSTRACT: Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST.A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT)?+?TAU, or 3) Personal Goal Setting (PGS)?+?TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support).A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall).Patients receiving OST can be recruited into a trial of a social network-based intervention, but poor attendance at treatment sessions makes it uncertain whether an adequate dose of treatment was delivered. In order to achieve the benefits of psychosocial interventions, further work is needed to overcome poor engagement.ISRCTN Trial Registration Number: ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

SUBMITTER: Day E

PROVIDER: S-EPMC5769270 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

Day Ed E Copello Alex A Seddon Jennifer L JL Christie Marilyn M Bamber Deborah D Powell Charlotte C Bennett Carmel C Akhtar Shabana S George Sanju S Ball Andrew A Frew Emma E Goranitis Ilias I Freemantle Nick N

BMC psychiatry 20180115 1

<h4>Background</h4>Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST.<h4>Methods</h4>A two-site, open ...[more]

PMID: 29334921

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Project description:BackgroundHigh levels of aggression towards staff in healthcare settings have been reported. It seems likely that workers in Opioid Substitution Therapy (OST) would be at increased risk of adverse events and their consequences.ObjectivesThis study aimed to establish if practitioners who provide OST are experiencing negative outcomes, specifically aggression, distress, and burnout, and to identify if workload and professional affiliation were associated with these risks.MethodsA survey was conducted of OST practitioners in a single geographical region of New Zealand (population approx. 344,000). The survey asked for demographics (including caseloads), Perception of Patient Aggression Scale New Zealand Revision (POPAS-NZ), Kessler 10 (K10), Short Post-Traumatic Stress Disorder Rating Interview (SPRINT), and Abbreviated Maslach Burnout Inventory (aMBI) and two qualitative questions asking about the best and worst aspects of working in OST.ResultsAll recorded OST workers in the region (n = 181) were invited to participate, 95 practitioners responded to the survey (52.4%). This group included pharmacists, doctors, nurses, social workers and addiction workers. Results indicated aggression, distress, and burnout were being experienced by practitioners. Number of patients seen by a practitioner significantly increased risk of aggression (F(1,90) = 14.14, p < 0.001). Psychiatrists were the most at risk profession (p = 0.016). Burnout responses were high for around 20% of practitioners, with low numbers meeting criteria for distress and PTSD. Positive things about working in OST were relationships with patients, appreciating patient outcomes and positive team environments. Negative aspects were patient behaviours, maintaining empathy, and, administration tasks.ConclusionsAggression was a workplace hazard for OST clinicians. Low rates of distress and PTSD symptoms were reported and some evidence of practitioner burnout. Practitioners reported positive relationships, making a difference and teamwork may have been improving this area of mental health work.

Project description:BackgroundStigma is prominent in the lives of autistic individuals and their families and contributes significantly to the challenges faced by families raising an autistic child. Parents and carers can feel blamed for their child's behaviour, feel socially excluded and isolated and suffer from low self-esteem and poor psychological well-being. This increases the risk of experiencing self-stigma which further exacerbates these and other negative consequences. Therefore, there is a need for interventions that help parents/family carers cope with autism-related stigma as well as prevent the internalisation of stigma.ObjectivesThe primary objective of this study is to assess the feasibility and acceptability of a stigma support intervention for parents and carers of autistic children titled 'Stigma of Living as an Autism Carer (SOLACE)'. The secondary objective is to explore the preliminary impact of the intervention on the mental health of the parents and carers.MethodsA pilot randomised controlled trial feasibility study will be implemented. A group receiving the SOLACE stigma support intervention (n?=?12) will be compared against a control group not receiving any additional intervention (n?=?12). Family carers of autistic children up to the age of 10, who have been recently diagnosed or are currently undergoing diagnosis, will be recruited for the study. Participants will be randomly allocated to the intervention or control group and will take part in eight weekly group-based sessions designed to improve the well-being of the parents primarily through increasing their resilience to stigma. Feasibility will be determined by recruitment and retention rates and a qualitative focus group evaluating the acceptability of the intervention and outcome measures. The primary outcome of interest is psychological well-being, and depending on the normality of distribution, independent samples T tests will be used to compare the outcome scores between the two groups and dependent samples T tests for differences within the group. Other outcomes of interest are stigma, self-stigma, self-esteem, self-blame, social isolation, self-compassion and perceived responsibility and control.DiscussionResults from the feasibility randomised controlled trial will be used to refine the study protocol and inform the design of an intervention for future use in a larger, powered trial. SOLACE could potentially improve the psychological well-being of parents/family carers of autistic children through increased resistance to stigma.Trial registrationISRCTN Registry number ISRCTN61093625 (October 13, 2017).

Project description:BACKGROUND:Depersonalisation is the experience of being detached or disconnected from one's experience. Studies suggest that clinically significant levels of depersonalisation are common in individuals who have psychotic symptoms and are associated with increased impairment. However, to date, there have been no studies that have investigated an intervention designed to target clinically significant depersonalisation in such patient groups. This study aims to determine the feasibility and acceptability of a brief intervention targeting clinically significant depersonalisation in those who also have current psychotic symptoms. METHODS/DESIGN:The feasibility of delivering six sessions of cognitive behavioural therapy for depersonalisation in psychosis patients will be evaluated using a single-blinded randomised controlled trial with a treatment as usual control condition. Participants will be assessed at baseline and then randomised to either the treatment or control arm. Participants randomised to the treatment arm will be offered six sessions of individual cognitive behavioural therapy delivered over a maximum of 10 weeks. Therapy will focus on an individualised shared formulation of depersonalisation experiences and behavioural, cognitive, emotional regulation and thinking process strategies to decrease distress associated with depersonalisation. Participants will be assessed again at a 10-week (post-randomisation) follow-up assessment. The primary outcomes of interest will be those assessing the feasibility and acceptability of the intervention including rates of referral, eligibility and acceptance to participate; attendance at therapy sessions and completion of homework tasks; satisfaction with the intervention; maintenance of blinding; and therapist competence. Secondary outcomes will be data on clinical outcome measures of depersonalisation and positive symptoms of psychosis, anxiety, depression and post-traumatic stress. DISCUSSION:This study will determine the feasibility of delivering six sessions of cognitive behavioural therapy for individuals with current psychotic symptoms who also experience clinically significant levels of depersonalisation. The results will provide information to inform a larger randomised trial to assess intervention efficacy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02427542.

Project description:Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20-30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n =?8-10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a-d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust.

Project description:IntroductionManaging medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. People living with dementia may require medication administration assistance from formal and informal caregivers. Simplified medication regimens maintain the same therapeutic intent, but have less complex instructions and administration schedules. This protocol paper outlines a study to determine the feasibility of a multicomponent intervention to simplify medication regimens for people receiving community-based home care services.Methods and analysisThis is a non-randomised pilot and feasibility study. Research nurses will recruit 50 people receiving community-based home care services. All participants will receive the intervention from a clinical pharmacist, who will undertake medication reconciliation, assess each participant's capacity to self-manage their medication regimen and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be a description of study feasibility (recruitment and retention rates, protocol adherence and stakeholder acceptability). Secondary outcomes include the change in number of medication administration times per day, medication adherence, quality of life, participant satisfaction, medication incidents, falls and healthcare utilisation at 4 months.Ethics and disseminationEthical approval was obtained from the Monash University Human Research Ethics Committee and the community-based home care provider organisation's ethical review panel. Research findings will be disseminated to consumers and caregivers, health professionals, researchers and healthcare providers through the National Health and Medical Research Council Cognitive Decline Partnership Centre and through conference presentations, lay summaries and peer-reviewed publications. This study will enable an improved understanding of medication management and administration among people receiving community-based home care services. This study will inform the decision to proceed with a randomised controlled trial to assess the effect of this intervention.Trial registration numberACTRN12618001130257; Pre-results.

Project description:Background and Purpose- Recognition of stroke symptoms and hospital prenotification by emergency medical services (EMS) facilitate rapid stroke treatment; however, one-third of patients with stroke are unrecognized by EMS. To promote stroke recognition and quality measure compliant prehospital stroke care, we deployed a 30-minute online EMS educational module coupled with a performance feedback system in a single Michigan county. Methods- During a 24-month study period, a registry of consecutive EMS-transported suspected or unrecognized stroke cases was utilized to perform an interrupted time series analysis of the impact of the EMS education and feedback intervention. For each agency, we compared EMS stroke recognition and quality measure compliance rates, as well as emergency department performance and hospital outcomes during 12 preintervention months with performance in the remaining study months. Results- A total of 1805 EMS-transported cases met inclusion criteria; 1235 (68.4%) of these had ischemic or hemorrhagic strokes or transient ischemic attacks. There were no trends toward improvement in any outcome before the intervention. After the intervention, the EMS stroke recognition rate increased from 63.8% to 69.5% ( P=0.037). Prenotification increased from 60.9% to 77.3% ( P<0.001). Among patients with ischemic stroke/transient ischemic attack, there was a trend toward higher rates of tPA (tissue-type plasminogen activator) delivery (13.9%-17.7%; P=0.096) and a significant increase in tPA delivery within 45 minutes (5.7%-8.9%; P=0.042) after intervention. However, improvements in EMS recognition were limited to the first 3 months following intervention. Conclusions- A brief educational intervention was associated with improved EMS stroke recognition, hospital prenotification, and faster tPA delivery. Gains were primarily observed immediately following education and were not sustained through provision of performance feedback to paramedics.

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A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

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A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

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