Background. Violent criminal offenders with personality disorders (PD’s) can cause immense harm, but are often deemed untreatable. This study aimed to conduct a randomized clinical trial to test the effectiveness of long-term psychotherapy for rehabilitating offenders with PDs. Methods. We compared schema therapy (ST), an evidence-based psychotherapy for PDs, to treatment-as-usual (TAU) at eight high-security forensic hospitals in the Netherlands. Patients in both conditions received multiple treatment modalities and differed only in the individual, study-specific therapy they received. One-hundred-three male offenders with antisocial, narcissistic, borderline, or paranoid PDs, or Cluster B PD-not-otherwise specified, were assigned to 3 years of ST or TAU and assessed every 6 months. Primary outcomes were rehabilitation, involving gradual reintegration into the community, and PD symptoms. Results. Patients in both conditions showed moderate to large improvements in outcomes. ST was superior to TAU on both primary outcomes – rehabilitation (i.e. attaining supervised and unsupervised leave) and PD symptoms – and six of nine secondary outcomes, with small to moderate advantages over TAU. ST patients moved more rapidly through rehabilitation (supervised leave, treatment*time: F(5308) = 9.40, p < 0.001; unsupervised leave, treatment*- time: F(5472) = 3.45, p = 0.004), and showed faster improvements on PD scales (treatment*- time: t(1387) = −2.85, p = 0.005). Conclusions. These findings contradict pessimistic views on the treatability of violent offenders with PDs, and support the effectiveness of long-term psychotherapy for rehabilitating these patients, facilitating their re-entry into the community
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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
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Abstract Background: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. Methods: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. Discussion: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem.
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Meestal is er geen specifieke oorzaak te vinden voor nekpijn. Fysiotherapie richt zich daarom op algemene zaken, zoals spierkracht en beweeglijkheid. We onderzoeken of er effectieve behandelingen zijn voor subgroepen met niet-specifieke nekpijn. Met deze inzichten kunnen we fysiotherapie verbeteren.Doel We willen inzicht krijgen in effectieve behandelingen bij subgroepen patiënten met niet-specifieke nekpijn. Dit leidt uiteindelijk tot kostenvermindering voor de maatschappij en een sneller en beter herstel van de patiënten. Resultaten Dit onderzoek loopt nog. Na afronding vind je hier een samenvatting van alle resultaten. Tot nu toe is duidelijk geworden dat de volgende behandelingen effectief kunnen zijn bij patiënten met niet-specifieke nekpijn: Behandelingen gericht op kracht en uithoudingsvermogen. Behandelingen gericht op coördinatie met gebruik van visuele feedback. Een voorbeeld hiervan is patiënten met een laserlamp een parcours laten uitvoeren op een scherm. De resultaten van het onderzoek worden verwerkt in het bachelor- en masteronderwijs en cursussen binnen het werkveld. Looptijd 01 december 2015 - 01 december 2020 Aanpak Dit onderzoek bestaat uit verschillende delen: We onderzoeken wat er vanuit wetenschappelijk onderzoek al bekend is over de relatie tussen beperking in activiteit en een passende behandeling. We voeren een Delphi-studie uit onder deskundigen naar het behandelen van mensen met niet-specifieke nekpijn. We vragen ze naar een overeenstemming over de relatie tussen beperking in activiteit en een algemene behandeling, zoals het trainen van spierkracht. We onderzoeken of beweegoefeningen en/of manipulaties, als meest onderzochte behandelingen bij mensen met nekpijn, zo zijn beschreven dat we het kunnen hergebruiken. In de laatste studie onderzoeken we of beweegoefeningen en/of manipulaties effectief zijn in het herstellen van de beweeglijkheid. Het gaat hierbij om een subgroep van mensen met nekpijn die ook beperkt zijn in hun beweeglijkheid. Rapporten tot nu toe: The clinical reasoning process in randomized clinical trials with patients with non-specific neck pain is incomplete: A systematic review. Maissan F, Pool J, de Raaij E, Mollema J, Ostelo R, Wittink H. Musculoskelet Sci Pract. 2018 Jun;35:8-17 Clinical reasoning in unimodal interventions in patients with non-specific neck pain in daily physiotherapy practice, a Delphi study. Maissan F, Pool J, Stutterheim E, Wittink H, Ostelo R., Musculoskelet Sci Pract. 2018 Oct;37:8-16
