Valencia 2007.

Methods	Randomized controlled trial
Participants	The study location was hospital of the INPRF, National Institute of Health of the Ministry of Health, Mexico 49 participants were randomized to the intervention group and 49 participants were randomized to the control group The inclusion criteria were outpatients who were taking anti‐psychotic (AP) medication and were clinically stable in terms of their psychotic symptoms, men or women aged 16 to 50 who had completed at least 6 years of elementary education, lived with their families and resided in Mexico City or the metropolitan area, and who had provided written informed consent to participate in the research project.
Interventions	Intervention: PSYCHOSOCIAL SKILLS TRAINING (PSST) PSST is psychosocial skills training. It is composed of 7 treatment areas: (1) symptom management, (2) medication management, (3) social relations, (4) occupational, (5) money management, (6) couple relations, and (7) family relations. A therapist's manual describes all the areas, the skills corresponding to each area, and the training strategies for each session. The trainers were 2 psychologists who used 6 learning activities to teach patients skills acquisition: (1) introduction and explanation of the skills to be taught, including preparing and motivating patients to participate actively in the learning activities; (2) demonstration of the skills by one of the therapists, followed by a question‐and‐answer segment that allowed for clarification; (3) role playing: patients practiced the skills by role playing during sessions; (4) role playing feedback to allow patients to identify the resources needed to perform the skills in the real world; (5) practice of skills in their natural environment; and (6) at the beginning of the following session a segment was dedicated to verifying the practice of the skills in the community; this information was registered in a skills learning check‐up list. The learning activities were similar to the 7 instructional techniques proposed for teaching social and instrumental skills to the severely mentally ill. These were modified to 6 learning activities for the participants of the present study. Patients participated in group sessions, 8 patients per group, with a time limit of 1 hour 15 minutes, once a week for a total of 48 sessions during 1 year of PSST. To verify that each treatment area was being covered systematically and adequately, a therapist fidelity evaluation form was used. Family therapy (FT) consists of 2 parts: the first was psychoeducation, which included 8 group sessions where all the patients' relatives received information about the illness, symptoms and medication management. The second part consisted of 4 sessions for each family, including the patient, oriented to problem solving as needed by each family to improve communication skills, the recognition and management of warning signs of relapse, the importance of medication and its side‐effects, compliance with AP medication, and keeping appointments with physicians. 2 family therapists conducted the FT. Recreational activities for the patients, conducted by an arts teacher, included singing, musical games, creative movement, and arts and crafts, once a week for 2 hours. Recreational activities were not considered as a therapeutic modality Control: TREATMENT AS USUAL Control group was treatment as usual, which was provided at the Schizophrenia Clinic of the INPRF by 2 clinical psychiatrists, who were blind to the 2 treatment conditions.They provided 20‐minute monthly appointments during a 1‐year period, controlled the prescription of their AP medication based upon the assessment of their psychotic symptoms, checked their medication compliance, recorded their attendance to the consultations, and registered all this information in their clinical files
Outcomes	The measures of adherence were self report, psychiatrist verification, and medical records. To obtain these data, patients were asked if they had taken their AP medication during treatment according to their psychiatrist's instructions. This information was verified using 2 sources: the patients' psychiatrist and the patients' medical records. Compliance occurred when patients took their AP medication in the full prescribed dose by their treating psychiatrist. A criterion of adequate compliance was determined when patients had taken at least 80% of the prescribed AP medication verified by all 3 sources. The patient outcomes were symptomatology, psychosocial functioning, global functioning, relapse, rehospitalization and adherence to intervention therapy. Symptomatology was assessed using the PANSS, which is a validated 30‐item scale. The Spanish adaptation consists of 3 subscales: positive (7 items), negative (7 items) and general psychopathology (GPS) (16 items). Each item is scored from 1 (absence of psychopathology) to 7 (extremely severe). Psychosocial functioning (PSF) was measured using the Psychosocial Functioning Scale (PSFS). Functioning was assessed in 5 areas (occupational, social, money management, marital, and familial), and the patient's global psychosocial functioning (GPSF) was also assessed. PSF evaluates role performance through the level of satisfaction reported by the patient in the above‐mentioned areas of functioning. The instrument is composed of a total of 35 items. Each item is scored from 1 (very satisfied) to 5 (very unsatisfied). A low score indicates better psychosocial functioning. Global functioning was evaluated using the Global Assessment of Functioning (GAF) scale in DSM‐IV, which measures the combination of 2 elements: (1) symptom severity, and (2) any serious impairment in psychological, social and occupational functioning on a mental health‐illness continuum (level of functioning). To evaluate intervention adherence, 2 elements were considered: (1) patients' attendance at sessions was registered to measure their percentage of attendance during the intervention, and (2) the level of therapeutic adherence was obtained by considering the number of patients who completed the intervention, compared with those who dropped out. To determine the corresponding therapeutic adherence, the levels of therapeutic adherence must be verified. The percentage of desertion (non‐adherence) was obtained by considering the number of patients who dropped out in comparison with the number of patients who initiated the intervention. Independent interviewers, properly trained in all research instruments and unaware of which study group the patients belonged to, evaluated the 2 groups under study: initial and final (12 months) assessments. To ensure blindness the interviewers were instructed to remind all patients to abstain from mentioning what type of treatment they were receiving.
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomization was not described in detail. "Clinic were randomly assigned to two groups: 49 patients to the PSST programme (experimental treatment) and 49 to TAU alone (control treatment)." (pg 1394)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled. "Clinic were randomly assigned to two groups: 49 patients to the PSST programme (experimental treatment) and 49 to TAU alone (control treatment)." (pg 1394)
Selective reporting (reporting bias)	Unclear risk	No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Blinded staff. "Independent interviewers, properly trained in all research instruments and unaware of which study group the patients belonged to, evaluated the two groups under study: initial and final assessments. To ensure blindness the interviewers were instructed to remind all patients to abstain from mentioning what type of treatment they were receiving. The independent interviewers did not participate in the treatment team and had no knowledge of the research project." (pg 1396)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ Blind assessment. "Independent interviewers, properly trained in all research instruments and unaware of which study group the patients belonged to, evaluated the two groups under study: initial and final assessments. To ensure blindness the interviewers were instructed to remind all patients to abstain from mentioning what type of treatment they were receiving. The independent interviewers did not participate in the treatment team and had no knowledge of the research project." (pg 1396)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ This is a subjective measure; there is no information on blinding
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Attrition rate was not similar between groups
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ Attrition rate was not similar between groups