Dataset Information

Protocol for a cluster randomised crossover pilot trial of Goal Management Training⁺ (GMT⁺) for methamphetamine use disorder.

ABSTRACT:

Background

Methamphetamine use disorder (MUD) is associated with executive dysfunctions, which are linked with poorer treatment outcomes. However, current treatments for MUD do not directly address cognition. We recently modified Goal Management Training (now Goal Management Training⁺; GMT⁺), a group-based intervention originally designed to improve executive functions after brain injury, to enhance suitability for MUD. Here, we describe the rationale and design of a trial which aims to determine the acceptability and feasibility of GMT⁺ during residential rehabilitation for MUD, and its impact on executive functions and clinical outcomes.

Methods

We used a cluster randomised crossover design: participants are randomised at the cluster level to receive either GMT⁺ or psychoeducation-control (Brain Health Workshop; BHW). GMT⁺ is delivered in four 90-min weekly sessions and includes a between-session journal with 10-min daily activities. The program targets attention, impulse control, goal-setting, and decision-making. BHW is a health-oriented intervention that delivers information about the brain and promotes healthy exercise, diet, and sleep. It is matched to GMT⁺ on program format, length, and time with therapists. We will recruit forty-eight participants with MUD from residential treatment services. Our primary outcomes are acceptability, feasibility, and self-reported executive functioning. Secondary outcomes include craving, quality of life and cognitive performance. Outcome assessments are performed at baseline, post-interventions, 4-week follow-up, and 12-week follow-up.

Conclusions

This study will provide GMT⁺ feasibility and acceptability data and will indicate initial efficacy on executive functions and clinical outcomes in residential treatment for MUD. Information from this pilot trial will inform a powered RCT.

SUBMITTER: Anderson AC

PROVIDER: S-EPMC9399476 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Protocol for a cluster randomised crossover pilot trial of Goal Management Training<sup>+</sup> (GMT<sup>+</sup>) for methamphetamine use disorder.

Anderson Alexandra C AC Robinson Alex H AH Lubman Dan I DI Verdejo-Garcia Antonio A

Contemporary clinical trials communications 20220811

<h4>Background</h4>Methamphetamine use disorder (MUD) is associated with executive dysfunctions, which are linked with poorer treatment outcomes. However, current treatments for MUD do not directly address cognition. We recently modified Goal Management Training (now Goal Management Training<sup>+</sup>; GMT<sup>+</sup>), a group-based intervention originally designed to improve executive functions after brain injury, to enhance suitability for MUD. Here, we describe the rationale and design of ...[more]

PMID: 36033363

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Project description:BackgroundMethamphetamine use disorder (MUD) is associated with executive dysfunctions, which are linked with poorer treatment outcomes including earlier drop out and relapse. However, current treatments for MUD do not address executive functions. Goal Management Training (GMT) is an evidence-based cognitive remediation program for executive dysfunction, although required modifications to enhance its relevance and application within addiction treatment settings. This study aimed to (1) tailor GMT to the key cognitive deficits and typical treatment duration of MUD; (2) explore consumers' (people with MUD) engagement with the revised program; (3) implement a prototype of the program with consumers; and (4) present the manualized standard administration to clinical service providers.MethodsWe followed the Medical Research Council Complex Interventions Framework and employed an evidence- and person-based intervention development process. We used a four-phased approach and collaborated with neuropsychology experts, design researchers in healthcare, consumers with MUD, and clinical service providers. Each aim was addressed in a separate study phase; including content refinement and review with neuropsychology experts (phase 1), intervention design and collaboration with consumers (phase 2), prototype development and review with consumers (phase 3), and final program modifications and review with clinical stakeholders (phase 4).ResultsFindings from phase 1 indicated support for targeting four cognitive processes (attention, impulse control, goal setting, and decision-making). Key feedback included the need to help habitualize cognitive strategies and to guide consumers in applying these strategies in emotionally salient situations. Findings from phases 2 and 3 indicated consumer support for the program strategies and materials but highlighted the need to further enhance the personal relevance of specific content and journal activities. Findings from phase 4 provided clinicians support for the revised program but indicated an opportunity to minimize unintended effects. We present the intervention materials for the final revised program, Goal Management Training+ (GMT+), in line with TIDieR guidelines.ConclusionsGMT+ targets key cognitive processes and is sensitive to the clinical needs of people with MUD. Our intervention development process was important for informing the active ingredients and materials for GMT+, and indicated initial consumer and provider acceptability prior to conducting a clinical trial.

Project description:BackgroundSupporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation.Methods/designA two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff.Trial registrationISRCTN18912042.

Project description:IntroductionCompromised integrity of the brain due to paediatric acquired brain injury (pABI) has been associated with cognitive impairment, particularly executive dysfunction, in addition to somatic and emotional symptoms and reduced everyday function. Goal Management Training (GMT) is a cognitive rehabilitation intervention for improving executive function (EF) that has received empirical support in studies of adults with ABI. The purpose of the present study is to determine the efficacy of a recently developed paediatric version of GMT (pGMT) for children and adolescents with ABI and reported executive dysfunction.Methods and analysisThis study protocol describes a parallel randomised controlled trial including allocation concealment and assessor blinding. Eighty survivors after pABI, aged 10-17 years at the time of intervention, will be recruited. Participants will be randomly allocated to either pGMT (n=40) or a psychoeducative control intervention (n=40; paediatric Brain Health Workshop). Both interventions consist of seven group sessions for participants and parents, followed by external cueing and telephone counselling. The study also includes involvement of teachers. Assessments will be performed at baseline, immediately postintervention and at 6 months' follow-up. Primary outcome measure will be changes in daily life EF as reported by parents (The Behavior Rating Inventory of Executive Function). Secondary outcomes include other assessments of EF (neuropsychological tests and questionnaires). Furthermore, we aim to assess generalisation effects of pGMT on other cognitive functions, as well as emotional, behavioural, adaptive and family function, academic performance, fatigue and quality of life.Ethics and disseminationResults from this study will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals, in addition to presentations at scientific conferences. The study will be conducted in accordance with the Helsinki declaration and the Ethical Research Involving Children (ChildWatch International and Unicef). In accordance to Good Clinical Practice our study includes safety and quality monitoring guarantees in compliance with research ethics and safety. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items for Reporting in Trials recommendations, in addition to being registered at ClinicalTrials.gov. The study has been approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/772).Trial registration numberNCT03215342.

Project description:IntroductionAs there is currently no pharmacological treatment for Parkinson's Disease Mild Cognitive Impairment (PD-MCI) with executive dysfunctions, specific cognitive interventions must be investigated. Most previous studies have tested bottom-up cognitive training programs but have not shown very good results.ObjectivesThe aim of this study was to test ease of implementation, differential safety and preliminary efficacy of two top-down (strategy-learning) home-based, individualized, cognitive interventions: Goal Management Training (GMT), adapted for PD-MCI (Adapted-GMT), and a psychoeducation program combined with mindfulness exercises (PSYCH-Mind).MethodsThis was a single-blind block-randomized between-group comparative study. Twelve PD-MCI with mild executive dysfunctions were divided in four blocks and randomly assigned to any of the two interventions. The participants were included if they had PD-MCI diagnosis (no dementia), with stabilized medication. Both groups (Adapted-GMT and PSYCH-mind) received five intervention sessions each lasting 60-90 minutes for five weeks. Measures were collected at baseline, mid-point, one-week, four-week and 12-week follow-ups. Executive functions were assessed with the Dysexecutive questionnaire (DEX) and the Zoo Map Test (ZMT). Quality of life (QoL) and psychiatric symptoms were also evaluated. Repeated measures ANCOVAs (mixed linear analysis) were applied to all outcomes.ResultsThere was one drop out, and both interventions were feasible and acceptable. Despite the small sample size limiting statistical power, patients of both groups significantly improved executive functions per the DEX-patient (Time: F(4,36) = 2.96, p = 0.033, CI95%: 10.75-15.23) and DEX-caregiver scores (Time: F(4,36) = 6.02, p = 0.017, CI95%: 9.63-17.23). Both groups significantly made fewer errors between measurement times on the ZMT (Time: F(3,36) = 16.66, p = 0.001, CI95%: 1.07-2.93). However, QoL significantly increased only in PSYCH-Mind patients at four-week follow-up (interaction Time*Group: F(4,36) = 5.31, p = 0.002, CI95%: 15.33-25.61).ConclusionBoth interventions were easily implemented and proved to be safe. Because both interventions are arguably cost-effective, these pilot findings, although promising, need to be replicated in large samples.Clinicaltrials.gov identifierNCT04636541.

Project description:INTRODUCTION:0.9% saline and Ringer's lactate are the two most common resuscitation crystalloid fluids. 0.9% saline may lead to hyperchloraemic metabolic acidosis and may be associated with impaired kidney function and death. Few large multicentre randomised trials have been conducted to evaluate the effect of these two fluids on clinically important outcomes. METHODS:FLUID is a pragmatic pilot cluster randomised crossover trial in which four hospitals will be randomised to normal saline or Ringer's lactate for 14 weeks, then crossover to the alternative fluid for the subsequent 14 weeks after 1 to 3 week transition. With waiver of informed consent, all adult and paediatric patients admitted to participating sites will be included in the FLUID trial except for neonates. Primary feasibility outcome is study fluid protocol adherence (target:≥80%). Secondary feasibility outcomes include time to research ethics board (REB) approval and readiness to trial initiation (≤3 months from REB submission and approval). Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes for the future large FLUID trial will be described. Protocol adherence will be collected by site at specified time points. All clinical data will be obtained at patient level through provincial health administrative data held at the Institute for Clinical Evaluative Sciences (ICES). Event rates for the primary and secondary outcomes will be described using frequencies and proportions with 95% CIs. Intracluster and interperiod correlation coefficients will be calculated from population-level data available at ICES. ETHICS AND DISSEMINATION:The study protocol has been approved by the Ottawa Health Science Research Ethics Board. The FLUID pilot will determine feasibility, and ICES data across all potential sites in Ontario will allow calculation of sample size parameter estimates to inform the design and implementation of the large trial. TRIAL REGISTRATION NUMBER:NCT02721485; Pre-results.

Project description:BackgroundPregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives' implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures.MethodsGLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives' acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women's acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically.ResultsIn intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3-8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable.ConclusionsThis rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out.Trial registrationISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894 .

Dataset Information

Protocol for a cluster randomised crossover pilot trial of Goal Management Training⁺ (GMT⁺) for methamphetamine use disorder.

Background

Methods

Conclusions

Publications

Protocol for a cluster randomised crossover pilot trial of Goal Management Training<sup>+</sup> (GMT<sup>+</sup>) for methamphetamine use disorder.

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Dataset Information

Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder.

Background

Methods

Conclusions

Publications

Protocol for a cluster randomised crossover pilot trial of Goal Management Training<sup>+</sup> (GMT<sup>+</sup>) for methamphetamine use disorder.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Protocol for a cluster randomised crossover pilot trial of Goal Management Training⁺ (GMT⁺) for methamphetamine use disorder.