Severe mental illness (SMI) imposes a significant burden on individuals, resulting in long-lasting symptoms, lower social functioning and impaired physical health. Physical activity (PA) interventions can improve both mental and physical health and care workers can serve as healthy role models. Yet, individuals with SMI face barriers to PA participation. This study evaluated the effects of Muva, and assessed if mental health worker’s (MHW) characteristics were associated with clients’ change in social functioning. Muva, an intervention package primarily created to increase PA of people with SMI, places a special focus on MHWs as they might play a key role in overcoming barriers. Other PA barrier-decreasing elements of Muva were a serious game app, lifestyle education, and optimization of the medication regime. Method: This study is a pragmatic stepped wedge cluster controlled trial. Controls received care as usual. Mixedeffects linear regressions were performed to assess changes in the primary outcome social functioning, and secondary outcomes quality of life, psychiatric symptoms, PA, body mass index, waist circumference, and blood pressure. Results: 84 people with SMI were included in three intervention clusters, and 38 people with SMI in the control cluster. Compared to the control condition, there was significant clinical improvement of social functioning in interpersonal communication (p=<0.01) and independent competence (p=<0.01) in people receiving Muva. These outcomes were not associated with MHW’s characteristics. There were no changes in the other outcome measures. Conclusions: Muva improved social functioning in people with SMI compared to care as usual.
IMPORTANCE People with a severe mental illness (SMI) have a life expectancy reduced by 10 to 20 years compared with the general population, primarily attributable to cardiometabolic disorders. Lifestyle interventions for people with SMI can improve health and reduce cardiometabolic risk. OBJECTIVE To evaluate the effectiveness of a group-based lifestyle intervention among people with SMI in outpatient treatment settings compared with treatment as usual (TAU). DESIGN, SETTING, AND PARTICIPANTS The Severe Mental Illness Lifestyle Evaluation (SMILE) study is a pragmatic cluster randomized clinical trial performed in 8 mental health care centers with 21 flexible assertive community treatment teams in the Netherlands. Inclusion criteria were SMI, age of 18 years or older, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater. Data were collected from January 2018 to February 2020, and data were analyzed from September 2020 to February 2023. INTERVENTIONS Weekly 2-hour group sessions for 6 months followed by monthly 2-hour group sessions for another 6 months, delivered by trained mental health care workers. The intervention targeted overall lifestyle changes, emphasizing establishing a healthy diet and promoting physical activity. TAU (control) did not include structured interventions or advice on lifestyle. MAIN OUTCOMES AND MEASURES Crude and adjusted linear mixed models and multivariable logistic regression analyses were performed. The main outcome was body weight change. Secondary outcomes included changes in body mass index, blood pressure, lipid profiles, fasting glucose level, quality of life, self-management ability, and lifestyle behaviors (physical activity and health, mental health, nutrition, and sleep). RESULTS The study population included 11 lifestyle intervention teams (126 participants) and 10 TAU teams (98 participants). Of 224 included patients, 137 (61.2%) were female, and the mean (SD) age was 47.6 (11.1) years. From baseline to 12 months, participants in the lifestyle intervention group lost 3.3 kg (95%CI, −6.2 to −0.4) more than those in the control group. In the lifestyle intervention group, people with high attendance rates lost more weight than participants with medium and low rates (mean [SD] weight loss: high, −4.9 [8.1] kg; medium, −0.2 [7.8] kg; low, 0.8 [8.3] kg). Only small or no changes were found for secondary outcomes. CONCLUSIONS AND RELEVANCE In this trial, the lifestyle intervention significantly reduced weight from baseline to 12 months in overweight and obese adults with SMI. Tailoring lifestyle interventions and increasing attendance rates might be beneficial for people with SMI. TRIAL REGISTRATION Netherlands Trial Register Identifier: NTR6837
Abstract Background Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and efectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Methods A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verifed by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical ftness, cardiovascular risks, substance use, quality of life, and health-related self-efcacy at 12months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals. Discussion The results of the KISMET trial will contribute to the evidence gap of efective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system. Trial registration Netherlands Trial Register, NTR9783. Registered on 18 October 2021.
