Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses (PHYSICO-DSM-VR)

Azienda ULSS di Verona e Provincia

Status: Completed

Conditions: Psychotic Disorders; Bipolar Disorders

Treatments: Behavioral: Health Promotion Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02807688

CE 1518

Details and patient eligibility

About

The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.

Full description

Epidemiological studies investigating the mortality and physical health of mental patients have provided substantial evidence of an excess mortality and of a substantially higher prevalence of physical co-morbidity as compared to the general population. These findings have been related to a higher prevalence of risk factors like high blood pressure, high plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects.

The number of clinical trials and intervention studies in this area is still scanty and their scientific strength is relatively modest. The present research project aims at implementing preventive strategies related to dietary habits and physical exercise, and studying their efficacy with a randomized controlled study.

Enrollment: 325 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICD-10 diagnosis of affective or non-affective functional psychosis (codes F20-22, F24, F25, F28-F31, F23.3, F33.3)
• one or more contacts with the CMHS in the 3 months preceding the beginning of the recruitment
• Age 18-65

Exclusion criteria

• moderate or severe mental handicap (learning disability)
• organic brain disorders
• lack of capacity to consent to inclusion
• subjects already involved in individual treatment related to diet and physical exercise
• subjects deemed unable or unfit to participate in the proposed physical activities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 2 patient groups

Intervention

Experimental group

Description:

"Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques.

Treatment:

Behavioral: Health Promotion Intervention

Control

No Intervention group

Description:

Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health.