Trial Outcomes & Findings for A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder (NCT NCT01934972)

Study recruitment ended early due to the PI leaving the institution where the research was being completed (i.e., University of Arizona). Thus, only 23 people were enrolled in the study.

Six individuals of the 30 who were screened were not assigned to either of the intervention conditions. Four of these individuals dropped out prior to randomization to study arm. One was excluded due to an uncontrolled eating disorder, and one was excluded due to kidney dysfunction.

A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder

Level of cognitive functioning will be assessed via overall cognitive composite score from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery. Scores on the MATRICS are presented at T-scores with a mean of 50 and standard deviation of 10 as compared to a normative sample. The possible range of scores are 0-100. Higher scores are indicative of better cognitive functioning. Change from baseline in cognitive functioning was calculated by taking the MATRICS overall cognitive functioning score at 26-week follow-up and subtracting the MATRICS overall cognitive composite score from baseline. Positive values on this score are indicative of improvements in cognitive functioning from baseline. Missing values on the MATRICS were addressed using multiple imputation

Manic symptomatology assesed using the Yung Mania Scale. Total scores on this scale range from 0 to 60 with higher scores indicative of greater severity of manic symptoms. Change scores from baseline were calculated by subtracting baseline total scores on this measure from 26-week scores. For this change score, positive values indicate that manic symptom severity was worse at 26-week follow-up than at baseline

Depressive symptomatology assessed using the Inventory of Depressive Symptomatology (Clinician-Rated). Total scores on this measure range from 0-84 with higher scores indicative of worse depressive symptomatology. Change from baseline in depressive symptomatology was calculated by subtracting baseline scores on the Inventory of Depressive Symptomatology from 26-week scores on this measure. Positive values of this change score indicate that depressive symptoms were worse at 26-week assessment than at baseline assessment.

Social functioning assessed using the Social Functioning Scale. Total score calculated by converting all subscale scores to a standard score with mean = 100 and standard deviation = 15. These subscale scores are then averaged to calculate the total score. There is no set minimum or maximum on this scale given this scoring procedure. Change from baseline in social functioning was calculated by subtracting total scores at baseline assessment from total scores at 26-week. A positive value on this change score are indicative of better social functioning at 26-week assessment than at baseline.

Functional capacity assessed using the Brief University of California, San Diego Performance-Based Skills Assessment (UPSA). Scores range from 0-100 with higher scores indicative of greater functional capacity. Change score were calculated by subtracting baseline scores on the UPSA from scores from the 6-month assessment. Positive values are indicative of higher functional capacity at 26-week follow-up as compared to baseline assessment.

Health-related quality of life assessed using the RAND 36-Item Health Survey. Data are converted to Quality Adjusted Life Years (QALY) which has a minimum of 0 and a maximum of 1. Higher scores are indicative of greater health-related quality of life. Change scores are calculated by subtracting baseline scores from scores from 26-week assessment. Positive values on this change score indicate that health-related quality of life was higher at 26-weeks than baseline.

Medication adherence assessed using the Medication Adherence Rating Scale. Higher scores on this measure are indicative of worse medication adherence. Scores on this scale range from 0-10. Change scores were calculated by subtracted scores on this measure at baseline from scores at 26-week assessment. Positive values on this change score are indicative of worse medication adherence at 26-week follow-up as opposed to baseline assessment.

Quality of life assessed using the World Health Organization Quality of Life Scale. A total score was calculated by averaging scores for the four subscales on this measure. Range for this total score is 0-100 with higher scores indicative of greater quality of life. Change scores were calculated by subtracting baseline scores on this measure from week-26 scores. Positive values for this change score indicate the quality of life scores were greater at week 26 than at baseline.

Stage of recovery assessed using the Stages of Recovery Instrument. This instrument identifies which phase of recovery the participant identifies themselves to be within: moratorium, awareness, preparation, rebuilding, and growth. Outcome presented in the number of participants identifying as being within the growth phase of recovery at 26-week followup

Metacognition assessed using the Metacognitive Awareness Inventory. Total scores on this measure range from 0-100 with higher scores indicative of greater metacognition. Change in metacognition from baseline was calculated by subtracting baseline total scores on this measure from total scores on this measure at 26-week assessment. Positive values on this change score indicate that metacognition scores were higher at 26-week assessment than at baseline assessment

Intrinsic motivation assessed using the Intrinsic Motivation Inventory (IMI). Scores on this measure range from 21-147 with higher scores indicative of greater intrinsic motivation. For the current study, we asked specifically about intrinsic motivation to participate in CR. Change scores were calculated by subtracting baseline total scores on this measure from total scores obtained at 26-week assessment. Positive values on this change score indicate that participants reported greater intrinsic motivation as 26-week assessment as compared to baseline assessment.

Assessed using the Systematic Assessment for Treatment Emergent Events. Number of participants who endorsed an adverse event during study participation