Activa’t per la salut mental! / “Get active!: Increase active participation of people with mental disorders and their families in their recovery processes”
| ISRCTN | ISRCTN15181312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15181312 |
| Protocol serial number | - |
| Sponsors | Catalan Federation of Mental Health (Federació Salut Mental Cataluny), Government of Catalonia (Generalitat de Catalunya), Federació Veus |
| Funders | Generalitat de Catalunya, Diputació de Barcelona (Barcelona provincial Government), Diputació de Girona (Girona provincial Government), Diputació de Lleida (Lleida provincial Government), Diputació de Tarragona (Tarragona provincial Government), Ajuntament de Barcelona (Barcelona Town Hall), Ministerio de Sanidad, Servicios Sociales e Igualdad, “la Caixa” Foundation, Otsuka Pharmaceutical (Spain), Janssen Pharmaceutical (Spain), Lundbeck (Spain), Fundació Privada Roca i Pi , Fundació Roviralta, Fundació Roca Salvatella |
- Submission date
- 18/05/2017
- Registration date
- 23/06/2017
- Last edited
- 17/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Catalan Federation of Mental Health (Federació Salut Mental Cataluny)
Nou de Sant Francesc, 42
Barcelona
08002
Spain
| Phone | +34 93 272 14 51 |
|---|---|
| mjsanpio@federacio.salutmental.org |
Public
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
Public
Federació Veus
Carrer del Correu Vell, 8
Barcelona
08002
Spain
 ORCID ID |
0000-0002-4163-6545 |
|---|
Scientific
Ivalua (Catalan Institut of public policy evaluation)
Pau Claris, 108
Barcelona
08009
Spain
| Phone | +34 93 554 53 00 |
|---|---|
| jordi.sanz@ivalua.cat |
Public
Federació Salut Mental Catalunya
Nou de Sant Francesc, 42
Barcelona
08002
Spain
| Phone | +34 93 272 14 51 |
|---|---|
| gmarcet@federacio.salutmental.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional multi-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | ACTIVAT |
| Study objectives | 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(s) | Comité Ético de Investigación Clínica Hermanas Hospitalarias del Sagrado Corazón de Jesús, 26/03/2015, ref: PR-2015-06 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Patient outcomes: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Total final enrolment | 222 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Spain
Study participating centres
Barcelona
08002
Spain
C/ Dr. Castany
S/N
Salt (Girona)
17190
Spain
Dr. Antoni Pujadas
38
Sant Boi de Llobregat (CP.) Barcelona
08830
Spain
Alcalde Rovira Roure
44
Lleida
25198
Spain
Baixos
Barcelona
08042
Spain
S/N
Sabadell (Barcelona)
08208
Spain
1-3
Manresa
Barcelona
08243
Spain
Igualada
Barcelona
08700
Spain
S/N
Tarragona
Reus
43206
Spain
S/N
Tarragona
43206
Spain
25-29
Barcelona
08003
Spain
Barcelona
Sant Boi de Llobregat
08830
Spain
08002
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/10/2022 | 11/07/2023 | Yes | No | |
| Results article | 16/10/2023 | 17/10/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/10/2023: Publication reference added.
11/07/2023: Publication reference and total final enrolment added.
