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INTRODUCTION: This study primarily aimed to evaluate the efficacy and safety of SaiLuoTong (SLT) on cognition in mild cognitive impairment (MCI). METHODS: Community-dwelling people with MCI aged ≥60 years were randomly assigned to 180 mg/day SLT or placebo for 12 weeks. RESULTS: Thirty-nine participants were randomized to each group (N = 78); 65 were included in the final analysis. After 12 weeks, the between-groups difference in Logical Memory delayed recall scores was 1.40 (95% confidence interval [CI]: 0.22 to 2.58; P = 0.010); Delis-Kaplan Executive Function System Trail Making Test Condition 4 switching and contrast scaled scores were 1.42 (95% CI: -0.15 to 2.99; P = 0.038) and 1.56 (95% CI: -0.09 to 3.20; P = 0.032), respectively; Rey Auditory Verbal Learning Test delayed recall was 1.37 (95% CI: -0.10 to 2.84; P = 0.034); and Functional Activities Questionnaire was 1.21 (95% CI: -0.21 to 2.63; P = 0.047; P < 0.001 after controlling for baseline scores). DISCUSSION: SLT is well tolerated and may be useful in supporting aspects of memory retrieval and executive function in people with MCI. Highlights: SaiLuoTong (SLT) improves delayed memory retrieval and executive function in people with mild cognitive impairment (MCI).SLT is well tolerated in people ≥ 60 years.The sample of community dwellers with MCI was well characterized and homogeneous.
RESUMEN
BACKGROUND: To reduce smoking and improve other health behaviours of people living with severe mental illness, healthy lifestyle interventions have been recommended. One approach to improving the availability of these types of interventions is to utilise the mental health peer workforce. The current study aimed to evaluate the feasibility of peer-workers facilitating a telephone delivered healthy lifestyle intervention within community based mental health settings. The study also examined preliminary outcomes of the intervention. METHODS: The study was conducted as a randomised controlled feasibility trial. In addition to treatment as usual, participants randomised to the Treatment Condition were offered BHC. This was an 8-session telephone delivered coaching intervention that encouraged participants to decrease their smoking, increase their intake of fruit and vegetables, and reduce their leisure screen time. Participants in the waitlist Control Condition continued to complete treatment as usual. All participants were engaged with Neami National, an Australian community mental health organisation. Peer-workers were also current employees of Neami National. RESULTS: Forty-three participants were recruited. The average number of sessions completed by participants in the Treatment Condition was 5.7 (SD = 2.6; out of 8-sessions). Seventeen participants (77%) completed at least half of the sessions, and nine participants (40%) completed all eight sessions. Participant satisfaction was high, with all participants followed up rating the quality of the service they received as 'good' or 'excellent'. When compared to the Control Condition, people in the Treatment Condition demonstrated greater treatment effects on smoking and leisure screen time. There was only a negligible effect on servings of fruit and vegetable. CONCLUSIONS: Results were promising regarding the feasibility of peer-workers delivering BHC. Good retention rates and high consumer satisfaction ratings in the Treatment Condition demonstrated that peer-workers were capable of delivering the intervention to the extent that consumers found it beneficial. The current results suggest that a sufficiently powered, peer delivered randomised controlled trial of BHC is warranted. STUDY REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR; Trial ID ACTRN123615000564550).
