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

PHYSICO-DSM-VR - Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses: a Prevalence Study and a Randomised Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Bipolar Disorders
• Intervention / Treatment: Behavioral: Health Promotion Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37126
    • UOC 1° Servizio Psichiatria - ULSS 20
  • Verona, Italy, 37126
    • UOC 2° Servizio Psichiatria - ULSS 20
  • Verona, Italy, 37134
    • UOC 3° Servizio Psichiatria - ULSS 20
  • Verona
    • San Bonifacio, Verona, Italy, 37047
      • UOC 4° Servizio Psichiatria - ULSS 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; "Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques.	Behavioral: 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.
NO_INTERVENTION: Control; Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of participants that comply with WHO recommendations on diet and/or exercise	Following the criteria proposed by World Health Organization for a healthy lifestyle: at least 5 servings of fruit/vegetables per day and at least 30 minutes of moderate physical activity per day 5 days a week. Achieving at least one more criterion than baseline at follow up is considered a success.	baseline, month 1, month 2, month 3, month 4, month 5 and month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical examination	Physical examination by psychiatrist	baseline
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)	Questionnaire assessing chronic diseases, administered by investigators	baseline
Change in blood pressure		baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in pulses		baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in Body Mass Index		baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in waist circumference		baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in glycemia		baseline and month 6
Change in haemoglobin A1C		baseline and month 6
Change in LDL cholesterol		baseline and month 6
Change in HDL cholesterol		baseline and month 6
Change in triglyceridemia		baseline and month 6
Electrocardiogram		baseline
Medication History Schedule	Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant	baseline
36 Item Short Form Health Survey		beginning and month 6
Verona Service Satisfaction Scale - European Version		beginning and month 6

Collaborators and Investigators

• Sponsor: Azienda ULSS di Verona e Provincia
• Collaborators: Universita di Verona; FONDAZIONE CARIVERONA
• Investigators: Principal Investigator: Lorenzo Burti, Professor, Universita di Verona

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (ESTIMATE): June 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2016
• Last Update Submitted That Met QC Criteria: June 22, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: risk factors; health promotion; lifestyles; behavioural change; physical comorbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: CE 1518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED