Full Randomised Controlled Trial Research Articles

"Pre-schoolers in the playground" an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial.

BackgroundThe pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents.Methods/DesignOne hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via triaxial, accelerometry (Actigraph GT3X+), anthropometry (height, body mass, BMI, waist and upper arm circumference), health related quality of life for child (PedsQL) and parent (EQ5D), parent wellbeing (ComQol-A5), injuries and health service use. A health economic evaluation will also be undertaken.DiscussionIt is anticipated that results of this pilot trial will be published in spring 2015.Trial registrationCurrent controlled trials: ISRCTN54165860

Group person‐based cognitive therapy for chronic depression: A pilot randomized controlled trial

This pilot randomized controlled trial (RCT) assesses Person-Based Cognitive Therapy (PBCT), an integration of cognitive therapy and mindfulness, as a treatment for chronic depression. Twenty-eight participants with chronic depression were randomly allocated to treatment as usual (TAU) or PBCT group plus TAU. Assessments of depression (Beck Depression Inventory, BDI-II) and mindfulness (Southampton Mindfulness Questionnaire) were conducted before and after therapy. Intention-to-treat analysis found significant group by time interactions for both depression and mindfulness. Secondary analyses showed depression and mindfulness scores significantly improved for PBCT participants but not for TAU participants, with 64% of PBCT participants showing reliable improvement in depression, compared with 0% of TAU participants. PBCT is a promising treatment for chronic depression. Findings suggest a full RCT would be warranted.

A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment

Methadone maintenance remains the mainstay of treatment for opiate dependence in Scotland. Guidelines recommend supervised self-administration for at least 3 months, yet this is often interpreted as long-term supervision. However, there is no evidence base for deciding the optimal period of supervision. We tested the feasibility of conducting a randomised controlled trial (RCT) of different supervision models. Three armed pilot RCT, set in three Scottish treatment areas, recruited opiate-dependent patients who had received methadone treatment for 3 months. Participants were randomised to: (i) no supervision; (ii) twice weekly supervision; or (iii) daily supervision for further 3 months. As a pilot, key process measures were: recruitment rates, follow-up rates and treatment fidelity. We also wanted to estimate effect sizes of two co-primary outcomes for a full RCT: treatment retention and illicit heroin use. The recruitment target was 60 participants. One hundred and two eligible patients were identified, 60 (59%) participated, and 46 followed up (77%). Study fidelity was good with two participants moving group. Those randomised to no supervision were significantly happier with their group allocation. No significant differences were found in primary outcomes, although retention decreased with increased supervision, while illicit heroin use was least in those most supervised. It is possible to recruit and randomise participants to an RCT comparing different forms of supervised consumption. Pilot data suggest increased supervision may reduce illicit heroin use, but may decrease retention. This should now be tested in a large-scale multicentre RCT.

Using acupuncture to treat depression: A feasibility study

To establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. Control group intervention, blinding of treatment, outcome measures and the acceptability of such a trial amongst participants were key factors to be addressed. The findings from this study will be used to determine the design of a phase III randomised controlled trial. Nineteen participants were recruited through general practices in London, UK. Participants were randomly assigned on a 2:1 basis to either 12 sessions of verum acupuncture or 12 sessions of sham acupuncture (control). Sham acupuncture involved actual needling but at sites considered to be unrelated to depression. The Beck's Depression Inventory (BDI) and the RAND 36 Item Health Survey 1.0 (RAND) were completed at baseline and at the end of treatment or at treatment dropout. All participants also attended a brief qualitative interview at the end of the study. Treatment dropout was low and there were high levels of patient enthusiasm for a study of acupuncture. Referrals from General Practitioners (GPs) were lower than expected. The sham control method successfully maintained participant blinding to treatment and enabled the specific (or active) component of an acupuncture intervention to be isolated and its efficacy assessed. The outcome measures were sensitive enough to record changes in depressive symptoms and quality of life and are appropriate for use in a larger trial. This feasibility study has provided important information that can be used to guide the design and methodology of a full-randomised controlled trial.

A Pilot Study to Investigate the Combined Use of Botulinum Neurotoxin Type A and Functional Electrical Stimulation, with Physiotherapy, in the Treatment of Spastic Dropped Foot in Subacute Stroke

The objective was to inform sample size calculations for a full randomized controlled trial (RCT). The design included an RCT pilot trial with a 16 week study period, including a 4 week baseline phase. The subjects were adults within 1 year of first stroke, ambulant with a spastic dropped foot. Twenty-one participants were recruited from the stroke services of 4 centers. For intervention all participants received physiotherapy; the treatment group also received botulinum neurotoxin Type A (BoNTA) intramuscular injections to triceps surae (800 U Dysport) and functional electrical stimulation (FES) of the common peroneal nerve to assist walking. The main outcome measure was walking speed. The result was a significant upward trend in median walking speed for both the control (p = 0.02) and treatment groups (nonstimulated p = 0.004, stimulated p = 0.042). Trend lines were different in location (p = 0.04 and p = 0.009, respectively). In conclusion, there is evidence of an additional, beneficial effect of BoNTA and FES. Sufficient information has been gained on the variability of the primary outcome measure to inform sample size calculations for a full RCT to quantify the treatment effect with precision.