Comprehensive rehabilitation and job reintegration of people with severe mental illness in a Latin American country: REINTEGRA study protocol

To evaluate the effectiveness of the implementation of the REINTEGRA program, which includes cognitive, behavioral, social, and occupational rehabilitation of people with SMI.

Quasi-experimental prospective, longitudinal study (with control group without random assignment), of pragmatic or naturalistic type. The REINTEGRA program was designed with the intention of intervening in the participants’ usual environment to give greater weight to external validity, since the aim is to transfer it into daily practice with the expectation of obtaining the same effectiveness as in the original design. Figure 1 summarizes the process that REINTEGRA participants will follow. The program is designed to be developed in three phases: Phase 1 will carry out initial assessments, psychoeducation program, SST, and training in ADL; Phase 2 will include the application of CBCR, MCT and CT-R programs; Phase 3 will include the application of SOJI training and the process of job insertion.

Both the informed consent and the present study will be carried out in accordance with the scientific and ethical principles of beneficence, non-maleficence, autonomy and justice for research in humans in accordance with the Declaration of Helsinki and its amendments, having been approved by the Research and Ethics Committee of the Mental Health Institute of Jalisco (SALME), number: 205–2021.

All phases of REINTEGRA will be carried out at Centro de Atención Integral de Salud Mental Estancia Prolongada, by its acronym in Spanish (CAISAME-EP), which is part of the Jalisco Mental Health Institute (SALME). The multidisciplinary team of CAISAME-EP will include psychiatrists, general practitioners, psychologists, nurses, and social workers, who will be trained in the same facilities of CAISAME-EP for the proper implementation of the program.

Men and women aged 18 to 55 who have been diagnosed with SMI and are being treated at SALME will be offered to participate in the study, whether they are hospitalized and about to be discharged or receiving outpatient care but who, at the discretion of the attending physician, are candidates for rehabilitation programs. Interventions and sequential steps of the protocol are described in the Assesment tools and Procedures section.

The sample size was calculated using the formula for contrasting hypotheses on two proportions [22], where the expected success rate is 40% (p1 = 0.40) for the intervention group, compared to a rate of 10% (p2 = 0.10) reported under normal treatment conditions. A significance level of 5% (α = 0.05) and a statistical power of 80% (β = 0.80) were considered. As a result, a sample of 19 subjects per group was obtained, but due to the expected losses and the need to perform parametric tests, it was decided to increase the sample number to 30 subjects per group.

1) SALME users diagnosed with SMI (schizophrenia, bipolar disorder, schizoaffective disorder and other non-organic psychoses) with at least two years of history, according to the International Classification of Diseases (ICD-10); 2) that they do not carry out any remunerated activity; 3) under pharmacological treatment and control of symptoms; 4) achieving a score > 50 on the Global Assessment of Functioning (GAF, integrated into the DSM-IV-TR); 5) who can read and write; 6) commitment to attend the sessions required by REINTEGRA (only for the intervention group).

1) Active use of non-pharmacological psychoactive substances other than tobacco, 2) diagnosis of intellectual development disorders and/or moderate or severe cognitive impairment, 3) suffering from chronic diseases that limit work capacity (cerebrovascular disease, renal failure, etc.), 4) presenting disruptive behaviour and/or active suicidal behaviour.

1) Withdrawal of informed consent, 2) worsening of the disorder that needs hospitalization, 3) incomplete initial assessment, 4) failure to meet at least 75% of the attendance at the REINTEGRA program, 5) development of a medical condition that limits their stay in the program.

At the beginning of the program, the sociodemographic data card will be completed, which includes age, sex, education, marital status, and religion; the Clinical Global Impression of schizophrenia (CGI-SCH) scale that quickly and easily measures positive, negative, depressive, and cognitive symptoms of schizophrenia will be applied monthly.

The other instruments will be applied at the beginning, after each phase and at the end of the program, according to their relevance (Table 1): the clinical data card (therapeutic adherence, clinical incidents per week, discharge from the intervention, relapse or rehospitalization, etc.); the Brief Psychiatric Rating Scale (BPRS), efficiently evaluates changes in symptoms such as somatic worries, psychological anxiety, emotional isolation, conceptual disorganization, among others; The Young Mania Rating Scale (YMRS), helps monitor euphoria, hyperactivity, sleep, irritability, among other symptoms during the last 48 h; Patient Health Questionnaire (Depression Scale, PHQ-9), is self-applicable and consists of nine items that assess the presence of depressive symptoms. The Social Occupational Functioning Scale (SOFS), which assesses self-care and activities of daily living, communication, interpersonal relationships and instrumental skills for life and work; the Internalized Stigma of Mental Illness (ISMI) scale, which evaluates stigma through three subscales: discrimination, revelation and positive aspects of mental illness; the Level of express emotion (LEE) is self-applicable and is directed to the patient’s family in order to obtain information about the family environment; the Recovery Assessment Scale (RAS 24) aims to assess the patient’s recovery expectations; WHO Quality of Life Survey (WHOQOL-BREF), provides a quality of life profile considering physical, psychological, social and environmental aspects. And finally, the Consensus Cognitive Battery MATRICS (MCCB MATRICS), which includes ten optimal tests to evaluate cognitive domains such as: processing speed, verbal fluency, attention, working memory, verbal and visual memory, reasoning and problem solving, among others. All instruments have their versions translated into Spanish and validated for the population of interest [23‐32].

The program proposed contemplates a standardized structure in three phases:

Attracting participants and assignment to intervention/comparison group. Once the attending physician identifies a potential participant, a member of the research team will explain what their participation in the program would be like and assess whether they adequately meet the inclusion and exclusion criteria. Participants who meet these criteria will be invited to participate in the intervention and will be divided into two groups: intervention (IG) and comparison (CG).

Those who meet the inclusion and exclusion criteria, and who also agree to participate in all phases of the program, will be part of the IG; the corresponding letter of informed consent will be obtained from the first 30 people who commit to adhering to the intervention. Those who do not agree to adhere to the intervention will be part of the CG, these participants will be given longitudinal follow-up, will have their usual management by their multidisciplinary mental health team and will be applied psychometric scales for comparison purposes, as well as a face-to-face psychoeducation course aimed at both the participant and their families (the same course will be applied to the IG). The decision not to carry out the random assignment is because participation in the intervention group requires the commitment of a strict adherence to the different interventions (compliance of at least 80%), so the IG would have a high risk of follow-up bias if the participants were not sure that they would be able to comply with it. Furthemore, forming a CG with participants who wanted to be part of the IG would mean denying them the possibility of receiving training that would be beneficial to them.

It should be noted that, regardless of the group to which they belong, participants should maintain their usual pharmacological treatment and be under control of the symptomatology of the disease. In addition, at the end of the study, comparison group members will be invited back to join the full program if they wish, thus resolving any ethical dilemmas.

Once the participant is assigned to a group, the initial assessment, which consists of two sessions, will begin. In the first, sociodemographic and clinical data will be obtained and the scales BPRS, YMRS, PH1-9, SOFS, LEE, RAS and WHOWQOL-BREF will be applied; in the second, the MATRICS neuropsychological battery will be administered and goals will be set (intervention in case of IG and usual treatment for CG), based on the clinical and job history of each person, and on their individual characteristics and needs, taking into account environmental factors that may influence their process.

This is the only part of the program that will be applied to both groups; it will consist of six sessions on mental health, mental disorders, and their treatment. Each session will last 1.30 h and will be given by the social work team to the individual with SMI and their family members. Once this part of the program has been completed, the appropriate scales will be applied to assess its effectiveness (see Table 1).

This part of the program will last six weeks and aims to empower the individual to be autonomous, safe, and effective in various activities of daily life (i. e. self-care, household skills, use of money and use of leisure time, to name a few), based on their current level of functioning.

It consists of two different procedures: (1) CBCR and (2) MCT. There is still uncertainty regarding the effectiveness of computer-based CR for the treatment of chronic SMIs.

On the other hand, MCT consists of ten total modules that address problematic thinking styles and congnitive biases that are closely related to delusions: increased internal attributions, jumping to conclusions, bias towards disconfirmatory evidence of initial beliefs, inability to take perspective or empathize with others, overconfidence in memory errors, depressive cognitive patterns, self-esteem, and stigma [33].

Rehabilitation and reintegration into the labor market. Based on the job objective set during the initial assessment, a job reintegration plan will be drawn up, which will include training for job skills through modeling techniques, direct training, and linkage with job reintegration programs. Each participant in the intervention group will be integrated into community work activities in accordance with the worker, employer and health professional handbook developed for this purpose. To facilitate this phase, it has the support of various institutions like the National Employment Service Jalisco Delegation. In addition, self-employment adapted to personal context and preferences will be an option.

Because within REINTEGRA, the participant is expected to return to their usual context after the interventions carried out, it is considered essential to follow-up six months after the program has concluded. This will be carried out by telephone with the support of the CAISAME-EP social work team.

Descriptive, bivariate, and multivariate analyses of the groups will be performed, considering pairing by main confounding variables (age sex, disease severity), as well as a stratified analysis by sex and socio-occupational background. The possible change in the clinical stability of the disorder, levels of functionality, internalized stigma, permanence of employment and all measures obtained through the scales will be analyzed.

Bayesian statistics shall be used for inferences regarding outcomes. Inferences will be carried out using hierarchical models since the same participant will have several measurements over time. The models will be adjusted using Stan within the rstan package in the R and SPSS statistical language. It was decided to use these statistical methods and present a 95% plausible interval, since this will allow us to accept the hypothesis as to whether outcomes differ between groups [34].