Schizophrenia Clinical Trial
Official title:
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
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).
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.
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