NCT02657941

Early and Short Psycho-educational Lifestyle Intervention

Early and Short Psycho-educational Lifestyle Intervention to Prevent Weight Gain Induced by Psychotropic Drugs in Adults With Severe Mental Illness: a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

People with severe mental illness have an increased risk of somatic comorbidities such as metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce an increased risk of early mortality, mainly because of cardiovascular diseases. These high cardio-metabolic risks result of several factors such as lack of access to medical care, a poor and unbalanced nutrition, physical inactivity and smoking but they are also exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed to treat their psychiatric disorder. These prevention and awareness interventions in lifestyle are most often implemented in ambulatory stabilized patients. Also weight gain occurs in the early months of treatment. The therapeutic education program evaluated in this study seeks to potentiate the effectiveness of these preventive measures through early awareness in hospitalized patients. Finally, this study aims to compare the efficacy of two early and short programs on health behavior: first a program inspired by motivational interviewing and behavioral psychotherapy and secondly an exclusively educational program (information, formative assessment).

Detailed description

This both psychoeducational programs have a common objective through different methods to promote early awareness of the lifestyle (physical activity and dietary balance) of hospitalized adult patients who receive a psychotropic medication that may cause increased morbidity cardiovascular mortality through excessive weight gain and development of metabolic syndrome. Both programs have the same number of sessions of the same duration (three weekly sessions of one hour); the same themes are addressed (risk of weight gain and cardiovascular risks induced by treatments, benefits of physical activity and of a balanced diet); only the psycho-educational methods differ. These programs are for patients with serious mental illness (mainly psychotic disorders and mood disorders), hospitalized in one of the four adult psychiatric units of the Eastern Sector of the Vinatier Hospital in Bron, France. Patients are treatment-naive or already under psychotropic drug(s) but a new antipsychotic or mood-stabilizer must have been started during this hospitalization. Patients are included on indication of their referring physician in hospital, as soon as their clinical status is compatible. They are randomized to one of two therapeutic educational groups. The two parallel modules of psycho-education are co-managed by two nurses specialized in psycho-education. The study is based on a module per month for 18 months. Patients included will receive three individual interviews with a nurse or psychiatrist: the first interview before module, the second after module and the third three months after module.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Motivational group	Three weekly sessions of one hour, co-managed by two nurses specialized in psycho-education Session 1: General information on the risk of weight gain and the means of prevention, motivational balance on the practice of physical activity, developing a personal goal, information about the sports center Session 2: brainstorming and card game on Food Hygiene Session 3: Find situations at risk of snacking and consider alternative lines
BEHAVIORAL	educational group	Three weekly sessions of one hour, co-managed by two nurses specialized in psycho-education Session 1: General information on the risk of weight gain and means of prevention, video on physical activity, discussions with therapists, information about the sports center Session 2: Video on Food Hygiene, discussions with therapists Session 3: Return on basic concepts covered in the first 2 sessions

Timeline

• Start date: 2015-12-09
• Primary completion: 2017-11-14
• Completion: 2017-11-14
• First posted: 2016-01-18
• Last updated: 2018-02-08

Locations

1 site across 1 country: France