Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia

5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.

Time frame: Averaged over study participation (up to 12 months)

Population: A priori hypothesis was that long-acting injectable risperidone would result in better medication adherence than oral risperidone, so CT and HBT groups were merged within each medication administration condition.

Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.

Time frame: Measured at baseline and 12 months

Population: All participants with MCCB outcome data.

Change in role functioning from baseline to the 6 month point (rated on a scale from 1= Extreme Role Dysfunction to 10 = Superior Role Functioning) is presented here.

Time frame: Baseline to 6 months

Population: Participants who received services from the supported education/employment specialist

Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.

Time frame: Baseline to 12 months

Population: Participants who received services from the Individual Placement and Support specialist.

Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.

Time frame: 12 months after randomization

Population: All participants with SUMD-R data at 12-month point.

Coping Response Inventory, which rates extent to which active coping strategies were used after a significant stressful life event. Range of possible scores is 1 to 4. Higher scores are better.

Time frame: Baseline to 12 months

Population: Participants with Coping Response Inventories completed for a comparable stressful life event at baseline and 12 months. This was so rare in practice that this outcome was not feasible to evaluate.

The Work Motivation scale is a factor score from the Work Personality Profile. The Work Personality Profile is a set of ratings based on interviewing the participant. Scores at each occasion can range from 8 to 32, with higher indicating better motivation. Scores reported here are changes from baseline to 12 months, which could range from -24 to 24 with higher being better.

Time frame: Baseline to 12 months

Population: Participants in school or jobs at baseline and 12 months, which allows change in Work Personality Profile ratings to be assessed.

Dichotomous measure: Presence of any of 3 psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring after randomization and until end of study participation (up to 12 months post baseline). BPRS was administered every two weeks throughout study participation.

Time frame: Occurence after randomization and until end of study participation (up to 12 mos.)

Population: A priori hypothesis was that RLAI would lead to fewer psychotic exacerbations/relapses than Oral Ris. No effect of CT vs. HBT was hypothesized, so CT and HBT conditions were merged within each medication administration condition.

Modified Work Section of the Social Adjustment Scale (SAS) was used to calculate the total number of weeks in school or competitive work. Range of possible values is 0 to 52, with higher numbers being better outcome.

Time frame: 12 months

Population: Participants who were served by the Individual Placement and Support specialist

Days after randomization that a participant continued to receive at least the assigned CT or HBT psychosocial treatment. If a participant needed to end the assigned medication condition (RLAI vs. Oral Ris), they continued in the psychosocial treatment so this outcome focused on the days in the assigned psychosocial treatment. Possible range is 1 to 365, with higher being a better outcome.

Time frame: 12 months

Population: All participants who received Individual Placement and Support

Change in rating on quality of work/school performance based on patient, employer, and/or teacher reports. The Quality of Work rating at baseline was subtracted from the same rating at 12 mos. Higher scores are better outcome.

Time frame: Baseline to 1 year

Population: This measure could be rated only for individuals who were in school or working at baseline and at 12 months, so it proved not to be useful due to the infrequent return to school or work by baseline.