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

Sponsor

Azienda ULSS di Verona e Provincia (Other)

Overall Status

Completed

CT.gov ID

NCT02807688

Collaborator

FONDAZIONE CARIVERONA (Other), Universita di Verona (Other)

325

Enrollment

Locations

Arms

Duration (Months)

81.3

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Bipolar Disorders	Behavioral: Health Promotion Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

325 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in the number of participants that comply with WHO recommendations on diet and/or exercise [baseline, month 1, month 2, month 3, month 4, month 5 and month 6]
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.

Secondary Outcome Measures

Physical examination [baseline]
Physical examination by psychiatrist
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT) [baseline]
Questionnaire assessing chronic diseases, administered by investigators
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 [baseline]
Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant
36 Item Short Form Health Survey [beginning and month 6]
Verona Service Satisfaction Scale - European Version [beginning and month 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UOC 4° Servizio Psichiatria - ULSS 20	San Bonifacio	Verona	Italy	37047
2	UOC 1° Servizio Psichiatria - ULSS 20	Verona		Italy	37126
3	UOC 2° Servizio Psichiatria - ULSS 20	Verona		Italy	37126
4	UOC 3° Servizio Psichiatria - ULSS 20	Verona		Italy	37134