Condition category
Mental and Behavioural Disorders
Date applied
18/05/2017
Date assigned
23/06/2017
Last edited
23/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Improvements in the treating mental disorders have moved toward a community-focused approach, leading to a decrease in the use of hospital services. This new approach may be able to improve the quality of life of people suffering from mental disorders, but it also puts more responsibility on relatives who need to take care of their family members. If a relative does not have the rights tools to provide the correct support to the patient, this can actually make their symptoms worse and decrease the quality of life for both the patient and their caregiver. A project called Activa’t (Get Active!) that is promoted by the Catalan government in Spain provides mental health training to patients and their caregivers. It aims to empower patients and carers to manage their own care and provide individualised guidance and counselling support. The aim of this study is to investigate the effectiveness of the Activa’t programme is at promoting patients and caregivers as managers of own care (through different tools for daily management and empowerment) in improving recovery, and reducing caregiver charge and use of health and social services.

Who can participate?
Adults aged 18 to 63 years old who have a mental disorder and their caregiver.

What does the study involve?
Participating patients and their caregivers are randomly allocated to one of two groups. Those in the first group receive the usual treatment through common health and social services. Those in the second group receive the usual treatment as well as the Activa’t programme. This programme includes education training, empowerment training modules and peer support groups. Participants also receive guidance and counselling. Participants are followed up at six and 12 months to assess their recovery and mental health symptoms.

What are the possible benefits and risks of participating?
Participants may benefit from gaining more skills to manage their care and recovery: having further information, further skills to deal with daily difficulties, better attitude in relation to the recovery process, and strengthened peer support links. There are no notable risks with participating.
No risks are expected. The treatment has no known specific side effects.

Where is the study run from?
This study is being run by the Catalan Federation of Mental Health (Spain) and takes place in 12 territorial centres in Catalonia (Spain).

When is the study starting and how long is it expected to run for?
October 2014 to December 2017

Who is funding the study?
The Funders include public and private institutions: Catalan Government (Spain), provincial and local governments, and different private companies and foundations.

Who is the main contact?
Maria Jesús San Pío
mjsanpio@federacio.salutmental.org

Trial website

http://activatperlasalutmental.org/

Contact information

Type

Public

Primary contact

Mrs Maria Jesús San Pío

ORCID ID

Contact details

Catalan Federation of Mental Health (Federació Salut Mental Cataluny)
Nou de Sant Francesc
42
Barcelona
08002
Spain
+34 93 272 14 51
mjsanpio@federacio.salutmental.org

Type

Public

Additional contact

Mr Emilio Rojo Rodés

ORCID ID

Contact details

Departament de Salut Generalitat de Catalunya
Consultant of Plan for Mental Health and Addictions
Hospital Benito Menni
Dr. Antoni Pujadas
38
Sant Boi de Llobregat
Barcelona
08830
Spain

Type

Public

Additional contact

Mr Francisco Eiroa Orosa

ORCID ID

http://orcid.org/0000-0002-4163-6545

Contact details

Federació Veus
Carrer del Correu Vell
8
Barcelona
08002
Spain

Type

Scientific

Additional contact

Mr Jordi Sanz

ORCID ID

Contact details

Ivalua (Catalan Institut of public policy evaluation)
Pau Claris
108
Barcelona
08009
Spain
+34 93 554 53 00
jordi.sanz@ivalua.cat

Type

Public

Additional contact

Miss Gemma Marcet

ORCID ID

Contact details

Federació Salut Mental Catalunya
Nou de Sant Francesc
42
Barcelona
08002
Spain
+34 93 272 14 51
gmarcet@federacio.salutmental.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

Promotion of patients with mental disorder and caregivers as managers of own integrated care, as a mean to improve recovery, reduce caregiver charge and reduce use of health and social services

Acronym

ACTIVAT

Study hypothesis

Study Aim:
The aim of this study is to investigate the effectiveness of a program to promote patients and caregivers as managers of own integrated care (through different tools for daily management and empowerment) in improving recovery, and reducing caregiver charge and use of health and social services.

Hypothesis:
1. Participating in the activities of the program Activa't (Get Active!) increases recovery and therefore individual capacity of people with mental disorders to manage their severe mental disorders
2. Participating in the activities of the program Activa't (Get Active!) reduces care burden for the main caregiver
3. Participating in the activities of the program Activa't (Get Active!) increases the size of support network of the main caregiver
4. Participating in the activities of the program Activa't (Get Active!) leads to reductions in medical services use and drugs consumption

Ethics approval

Comité Ético de Investigación Clínica Hermanas Hospitalarias del Sagrado Corazón de Jesús, 26/03/2015, ref: PR-2015-06

Study design

Interventional multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

People with mental health diagnostics and their caregivers. Diagnostics included: Schizophrenia, schizotipic disorder, schizoaffective disorder, Bipolar disorder and recurrent depressive disorder.

Intervention

Participants are recruited as two units, the patient and their informal caregiver through 12 territories. This study is implemented in two waves. Participants are randomly allocated using stratification to one of two groups.

Control group: Participants in the control group receive the usual treatment through common health and social services.

Treatment group: Participants in the treatment group receive their usual treatment as well as a structured circuit of services addressed to patients and caregivers aimed at promoting that people with mental disorders and their informal caregivers become managers of their own care.

The program includes validated and approved experiences which are consolidated into a single integrated care circuit that flows from the health vision to the social-based community perspective:
1. Psychoeducative training for people with mental health problems (Klau de Re) and family (PROENFA), provided by mental health services. This is given in 14 one and a half hour sessions for caregivers and 22 one hour sessions for people with mental disorders.
2. Training for the empowerment (PROSPECT) of people with mental health problems, family, and professionals, provided by families and patients associations. This includes two modules which take around 20 hours to complete.
3. Participation in peer support groups for people with mental health problems and their families, from associative aspect, in coordination with associations of people with mental health disorders and/or families. This involves 12 sessions which take one and half hour per session.

The total duration of the treatment is around eight to 12 months, depending on the calendar of each activity.

Participants also receive a service of guidance and counselling: Espai Situa't. It is an individualized service aimed at answering advice and orientation demands that people with mental disorders or their caregivers may have regarding mental health services and recovery process, as well as offering useful information regarding their daily needs. This service acts as a coordination point of all the program.

Participants are followed up with questionnaires at six and 12 months to assess their recovery, and mental health symptoms.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Patient outcomes:
1. Patient recovery (individual skill to manage their mental disorder) is measured using the STORI scale (Stages of recovery) at baseline, six and 12 months after finishing the psychoeducation program
2. Use of medical services is measured using administrative records (records of visits to the public health system) at baseline, six and 12 months after finishing the psychoeducation program
3. Drug use is measured using the administrative records (prescriptions in the public health system) at baseline six and 12 months after finishing the psychoeducation program

Caregiver outcomes:
1. Caregiver burden (objective and subjective family burden) is measured using the ECFOS II (based on the Family Burden Interview Schedule-Short Form (FBIS/SF) at baseline, six and 12 months after finishing the psychoeducation program
2. Caregiver support networks are measured using the Duke-UNK functional support questionnaire at baseline, six and 12 months after finishing the psychoeducation program
3. Use of medical services is measured using administrative records (records of visits to the public health system) at baseline, six and 12 months after finishing the psychoeducation program
4. Drug use is measured using the administrative records (prescriptions in the public health system) at baseline six and 12 months after finishing the psychoeducation program

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

30/10/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Eligibility criteria for the person with mental disorder:
1. To belong to one of the following diagnosis groups: Schizophrenia, Schizotypic disorder, schizoaffective disorder or delusional disorders (F20, F21, F22, F24, F25 (CIE10); 295, 301.22 (CIE9)) or bipolar disorder or recurrent depressive disorder (F31 and F33 (CIE10), 296 (CIE9))
2. More than two years of presence of any of the listed severe mental disorder, without necessarily implying diagnosis or treatment
3. To be aged 18 to 63 years
4. Moderate or severe dysfunction implying a GAF score (Global Assessment of Functioning, APA, 1987) below 60
5. To accept the participation conditions for the trial and agreeing on transferring personal data under the Spanish data protection regulation

Eligibility criteria for the carer:
1. To be the reference caregiver of the eligible person with a mental disorder
2. To be available to participate in all activities included in the treatment program
3. To accept the participation conditions for the trial and agreeing on transferring personal data under the Spanish data protection regulation

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

240 units of person with mental disorder and its main caregiver

Participant exclusion criteria

Exclusion criteria for the person with mental disorder:
1. Diagnosed with borderline personality disorder
2. Present co-morbidity with mental retardation
3. Present a sever associated somatic pathology
4. Disabled people residing in assisted residences and apartments for disabled persons
5. Participated in any training activity or support group similar to the ones offered in the Activa't framework

Exclusion criteria for the caregiver:
1. Suffer from a severe and uncompensated psychiatric or somatic disorder, including moderate or severe alcohol dependence
2. Participated in any training activity or support group similar to the ones offered in the Activa't framework

Recruitment start date

01/04/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Federació Salut Mental Catalunya
Nou de Sant Francesc, 42
Barcelona
08002
Spain

Trial participating centre

Institut d’Assistència Sanitària – IAS
Parc Hospitalari Martí i Julià C/ Dr. Castany S/N
Salt (Girona)
17190
Spain

Trial participating centre

Germanes Hospitalàries
Benito Menni, Complejo Asistencial en Salud Mental Dr. Antoni Pujadas 38
Sant Boi de Llobregat (CP.) Barcelona
08830
Spain

Trial participating centre

Gestió de Serveis Sanitaris
Hospital Universitari de Santa Maria Alcalde Rovira Roure 44
Lleida
25198
Spain

Trial participating centre

Associació Centre Higiene Mental Nou Barris
Passeig Valldaura 214 Baixos
Barcelona
08042
Spain

Trial participating centre

Corporació Parc Taulí
Parc Taulí S/N
Sabadell (Barcelona)
08208
Spain

Trial participating centre

Althaia
C/ Dr. Joan Soler 1-3 Manresa
Barcelona
08243
Spain

Trial participating centre

Salut Mental Consorci Sanitari de l’Anoia
Av. Catalunya, 11 Igualada
Barcelona
08700
Spain

Trial participating centre

Institut Pere Mata
Ctra. Institut Pere Mata S/N Tarragona
Reus
43206
Spain

Trial participating centre

Fundació Pere Mata Terres de l’Ebre
Ctra. Institut Pere Mata S/N
Tarragona
43206
Spain

Trial participating centre

Parc de Salut Mar, Barcelona
Passeig Marítim 25-29
Barcelona
08003
Spain

Trial participating centre

Parc Sanitari Sant Joan de Déu
Antoni Pujadas, 42 Barcelona
Sant Boi de Llobregat
08830
Spain

Trial participating centre

16 Associations of patients and caregivers in all the territory
You can find the updated list on the website: http://activatperlasalutmental.org/col%C2%B7laboradors/
08002
Spain

Sponsor information

Organisation

Catalan Federation of Mental Health (Federació Salut Mental Cataluny)

Sponsor details

Nou de Sant Francesc
42
Barcelona
08002
Spain
0034 93 272 14 51
gmarcet@federacio.salutmental.org

Sponsor type

Charity

Website

www.salutmental.org

Organisation

Government of Catalonia (Generalitat de Catalunya)

Sponsor details

Travessera de les Corts
131
Barcelona
08028
Spain

Sponsor type

Government

Website

www.gencat.cat

Organisation

Federació Veus

Sponsor details

Carrer del Correu Vell
8
Barcelona
08002
Spain

Sponsor type

Charity

Website

www.veus.cat

Funders

Funder type

Government

Funder name

Generalitat de Catalunya

Alternative name(s)

Government of Catalonia

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Funder name

Diputació de Barcelona (Barcelona provincial Government)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diputació de Girona (Girona provincial Government)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diputació de Lleida (Lleida provincial Government)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diputació de Tarragona (Tarragona provincial Government)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ajuntament de Barcelona (Barcelona Town Hall)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministerio de Sanidad, Servicios Sociales e Igualdad

Alternative name(s)

Ministry of Health, Social Services and Equality

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Funder name

“la Caixa” Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Otsuka Pharmaceutical (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Janssen Pharmaceutical (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lundbeck (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundació Privada Roca i Pi

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundació Roviralta

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundació Roca Salvatella

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

30/06/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes