Activa't per la Salut Mental / “Get active!: increase active participation of people with mental disorders and their families in their recovery processes”

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

2015-05-07

2017-09-30

* Patient Outcomes: Patient recovery
* Caregiver outcomes: Caregiver burden and support network
* Both agents: Use of medical services and drug use

* 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.

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.

Randomization done in office

Pair of person with mental disorder and its caregiver.

No

240 pairs of person with mental disorder and its caregiver

240 pairs of person with mental disorder and its caregiver

120 pairs in the treatment group
120 pairs in the control group

0.36 - 0.52 standard deviations