Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses

NCT ID: NCT02807688

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Detailed 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.

Conditions

Psychotic Disorders; Bipolar Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Health Promotion Intervention

Intervention Type: BEHAVIORAL

The intervention package consists of the following elements:

i. educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health Promotion Intervention

The intervention package consists of the following elements:

i. educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FONDAZIONE CARIVERONA

UNKNOWN

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: collaborator

Azienda ULSS di Verona e Provincia

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Burti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Burti, Professor

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

UOC 4° Servizio Psichiatria - ULSS 20

San Bonifacio, Verona, Italy

UOC 1° Servizio Psichiatria - ULSS 20

Verona, Verona, Italy

UOC 2° Servizio Psichiatria - ULSS 20

Verona, Verona, Italy

UOC 3° Servizio Psichiatria - ULSS 20

Verona, Verona, Italy

Countries

Italy

Other Identifiers

CE 1518

Identifier Type: -

Identifier Source: org_study_id