Activa't per la Salut Mental / “Get active!: increase active participation of people with mental disorders and their families in their recovery processes”
Last registered on May 17, 2017

Pre-Trial

Trial Information
General Information
Title
Activa't per la Salut Mental / “Get active!: increase active participation of people with mental disorders and their families in their recovery processes”
RCT ID
AEARCTR-0002076
Initial registration date
May 17, 2017
Last updated
May 17, 2017 3:23 PM EDT
Location(s)

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Primary Investigator
Affiliation
Catalan Institute of Public Policy Evaluation
Other Primary Investigator(s)
PI Affiliation
Federació Salut Mental Catalunya
PI Affiliation
Hermanas Hospitalarias SCJ Benito Menni CASM
Additional Trial Information
Status
On going
Start date
2015-04-01
End date
2017-12-31
Secondary IDs
Abstract
The improvements in the treatment of mental disorders have led to a decrease in the use of hospital services, which has been replaced by a community-focused approach. Even if this new approach has been able to improve the quality of life of people suffering from mental disorders, this has also implied a greater co-responsibility for those relatives who need to take care of the ill person. Moreover, in those cases in which relative caregivers do not have enough information and personal skills to provide a correct support to the patient, this new approach can derive into a worsening in the quality of life both for the person with the mental disorder and its caregiver.

In the benchmark of the project Activa't (Get Active!), promoted by the Catalan government, Federació Salut Mental Catalunya and Federació Veus, a randomly selected group of 120 families with a person with mental disorders will be offered threefold support services for the patient and its main caregiver. Firstly, a training program including a psychoeducational module for care givers and another one for affected people. Secondly, a program aimed at empowering both the people affected by mental disorders and their caregivers to become active health agents. And finally, providing continued support to families through peer support groups. The program offers also an individualized space aimed at providing guidance and counseling services to the families. This space manages and coordinates all the training program and peer support groups.

By empowering themselves and their families, this program aims at helping patients with mental disorders to move forward in their recovery, as well as reducing the care burden for their family.
External Link(s)
Registration Citation
Citation
Pío, Maria, Emilio Rojo and Jordi Sanz. 2017. "Activa't per la Salut Mental / “Get active!: increase active participation of people with mental disorders and their families in their recovery processes”." AEA RCT Registry. May 17. https://www.socialscienceregistry.org/trials/2076/history/17729
Experimental Details
Interventions
Intervention(s)
The intervention consist on providing people with mental disorders and their informal caregivers additional support to enhance patient's recuperation. This additional support is three fold:

1. Two psychoeducative training programs: one for people with mental health problems (Klau de Re) and another one for their relatives (PROENFA), both provided by mental health service professionals.

2. A training program aimed at empowering people with mental health problems, their family and mental health professionals (PROSPECT), from an associative point of view.

3. Participation in peer support groups for people with mental health problems and their families, also from an associative point of view, in coordination with associations of people with mental health disorder and associations of families of people with mental disorders.

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

The intervention is designed to be implemented in two waves, each one expanding through 6 territories.

The participants need to fulfill the following eligibility 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. To have a 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.

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

* Eligibility criteria for the caregiver:
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.

* Exclusion criteria for the caregiver:
1.To suffer from a severe and uncompensated psychiatric or somatic disorder, including moderate or severe alcohol dependence
2. To have participated in any training activity or support group similar to the ones offered in the Activa't framkework
Intervention Start Date
2015-05-07
Intervention End Date
2017-09-30
Outcomes
Outcomes (end points)
* Patient Outcomes: Patient recovery * Caregiver outcomes: Caregiver burden and support network * Both agents: Use of medical services and drug use
Outcomes (explanation)
* Patient recovery: individual skills to manage its mental disorder measured based on the stages of the STORI scale
* Caregiver burden: objective and subjective family burden based on The Family Burden Interview Schedule-Short Form (FBIS/SF), Richard Tessler, PH.D and Gail Gamache, Ph. D. (1994)- measured through ECFOS II
* Caregiver support network: support networks for patient care based on the Duke-UNK functional support questionnaire.
* Use of medical services: consumption of medical services measured through administrative records of visits to the public health system
* Drug use: consumption of medicines through administrative records of drugs prescriptions in the public health system benchmark.
Experimental Design
Experimental Design
1. The trial is run in 12 territories
2. In each territory, a process of reach out is undertaken to construct an initial sample of 240 pairs.
3. These 240 pairs are randomized in order to be evenly assigned either to the treatment (120) or the control group (120).
4. The intervention is implemented in two waves.
Experimental Design Details
Not available
Randomization Method
Randomization done in office
Randomization Unit
Pair of person with mental disorder and its caregiver.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
240 pairs of person with mental disorder and its caregiver
Sample size: planned number of observations
240 pairs of person with mental disorder and its caregiver
Sample size (or number of clusters) by treatment arms
120 pairs in the treatment group
120 pairs in the control group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.36 - 0.52 standard deviations
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Comité Ético de Investigación Clínica Hermanas Hospitalarias del Sagrado Corazón de Jesús
IRB Approval Date
2015-03-26
IRB Approval Number
PR-2015-06