Covid 19 Research using Clinical Trials (Home Page)
Report for D012559: Schizophrenia NIH
(Synonyms: Schiz, Schizo, Schizop, Schizophr, Schizophre, Schizophren, Schizophreni, Schizophrenia)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2250 | Sham Stimulation Wiki | 0.58 |
| drug1725 | PACE-Life Wiki | 0.58 |
| drug2414 | TAK-831 50 mg Wiki | 0.58 |
| drug2415 | TAK-831 500 mg Wiki | 0.58 |
| drug882 | Exercise Intervention Wiki | 0.58 |
| drug2424 | TDCS Wiki | 0.58 |
| drug1441 | Matching Placebo Wiki | 0.41 |
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders NIH | 0.58 |
| D011618 | Psychotic Disorders NIH | 0.29 |
| D001523 | Mental Disorders NIH | 0.12 |
| D004194 | Disease NIH | 0.10 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100753 | Schizophrenia HPO | 1.00 |
| HP:0000709 | Psychosis HPO | 0.29 |
There are 3 clinical trials
Clinical Trials
1 Restoration of Cognitive Function With TDCS and Training in Schizophrenia
Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with schizophrenia is a treatment priority. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is capable of stimulating brain activity to facilitate learning. The primary objective of this study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and tDCS, as a cognitively enhancing intervention. This study is designed to address four questions. Is cognitive remediation paired with tDCS more efficacious than cognitive remediation delivered with sham stimulation? Is it possible to predict responsiveness to the intervention? Is intervention-induced cognitive change sustainable? Are there barriers to implementing this intervention in clinical practice? To examine the incremental benefit of pairing tDCS with cognitive remediation, a 110 clinically stable outpatients between the ages of 18-60 who have a diagnosis of schizophrenia or schizoaffective disorder will be enrolled in a double-blind, double-baseline, sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive either tDCS or sham stimulation concurrent with working memory focused cognitive remediation. Training will be offered to participants in a small group format. Training will consist of 48 sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One hour will be spent completing cognitive exercises that require working memory skills on a computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the contralateral supraorbital position. Upon completion of working memory training, participants will transition to a 30-minute discussion group. The discussion will focus on application of cognitive skills in everyday life. Effective strategies for approaching cognitive tasks will be described and practiced. Participant experience with aspects of the training will be monitored with self-report measures of motivation, mood, and physical reactions. To assess intervention-induced change, working memory, other aspects of cognition, functional capacity, and community functioning will be assessed pre- and post-intervention. Cognitive outcomes will be assessed with training tasks as well as tasks that are unfamiliar to participants. A performance-based measure will be used to assess functional capacity for everyday living skills and a self-report instrument will be used to assess community functioning. Potential confounds such as symptom severity, medication changes, outside treatment hours, and significant life stressors will be assessed individually every 2 weeks during the intervention phase of the study. Sustainability of intervention-induced change will be assessed with assessment sessions 6 weeks and 6 months post-intervention. Change in performance during the first 12 training sessions on two working memory training tasks, a n-back task and a complex span task, will be used to determine if early response to treatment is predictive of post-intervention outcomes. An intent-to-treat analysis will be used to analyze intervention-induced change. Regression analyses will be conducted to identify predictors of treatment response. Achieving the proposed objectives will yield important information about the efficacy, durability, and efficiency of a novel pairing of cognitively enhancing interventions. Findings will inform treatment development for patients with schizophrenia as well for patients with other cognitively compromising illnesses.
NCT03208036 Schizophrenia Device: TDCS Device: Sham Stimulation MeSH:Schizophrenia
HPO:Schizophrenia
Primary Outcomes
Description: Working Memory Domain Age and Gender Corrected T-Scores on MATRICS Consensus Cognitive Battery
Measure: Working Memory Capacity Composite Score Time: Change from Baseline Working Memory Capacity at 4 months
Description: Average of MATRICS Consensus Cognitive Battery Attention Domain Age and Gender Corrected T-score and performance measured with d prime on the Dot Pattern Expectancy Task
Measure: Goal Maintenance Composite Score Time: Change from Baseline Goal Maintenance at 4 months
Description: Average of sensitivity measures on the Sternberg Item Recognition Paradigm and the Suppress Task
Measure: Interference Control Composite Score Time: Change from Baseline Interference Control at 4 months
Description: T-score
Measure: The University of California San Diego Performance-Based Skills Assessment Time: Change from Baseline T-score on Adaptive Skills test at 4 months
Secondary Outcomes
Description: Total score
Measure: First-Episode Social Functioning Scale Time: Change from Baseline Social Functioning at 4 months
Description: D-prime on N-back task
Measure: N-Back Performance Time: Change from Baseline N-back performance at 4 months
Description: Total Score
Measure: Complex Span Task Time: Change from Baseline Complex Span Task performance at 4 months
2 A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia
Primary Outcomes
Description: Working Memory Domain Age and Gender Corrected T-Scores on MATRICS Consensus Cognitive Battery
Measure: Working Memory Capacity Composite Score Time: Change from Baseline Working Memory Capacity at 4 monthsDescription: Average of MATRICS Consensus Cognitive Battery Attention Domain Age and Gender Corrected T-score and performance measured with d prime on the Dot Pattern Expectancy Task
Measure: Goal Maintenance Composite Score Time: Change from Baseline Goal Maintenance at 4 monthsDescription: Average of sensitivity measures on the Sternberg Item Recognition Paradigm and the Suppress Task
Measure: Interference Control Composite Score Time: Change from Baseline Interference Control at 4 monthsDescription: T-score
Measure: The University of California San Diego Performance-Based Skills Assessment Time: Change from Baseline T-score on Adaptive Skills test at 4 monthsSecondary Outcomes
Description: Total score
Measure: First-Episode Social Functioning Scale Time: Change from Baseline Social Functioning at 4 monthsDescription: D-prime on N-back task
Measure: N-Back Performance Time: Change from Baseline N-back performance at 4 monthsDescription: Total Score
Measure: Complex Span Task Time: Change from Baseline Complex Span Task performance at 4 monthsThe purpose of this study is to determine whether TAK-831 is superior to placebo in improving cerebellar function as measured with the average percentage of conditioned responses during the eyeblink conditioning (EBC) test.
NCT03359785 Schizophrenia Drug: TAK-831 500 mg Drug: TAK-831 50 mg Drug: Matching Placebo MeSH:Schizophrenia
HPO:Schizophrenia
Primary Outcomes
Description: EBC is a method used to investigate cerebellar function. In EBC, a conditioned stimulus (CS), a tone precedes but co-terminates with an unconditioned stimulus (US), an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response [CR]) occurs prior to the onset of the US. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned).
Measure: Average Percentage of Conditioned Responses During the Eye Blink Conditioning (EBC) Test at Day 8 Time: Day 8: For each treatment period
Secondary Outcomes
Description: MMN is an event related potential (ERP) evoked in response to unattended changes in background stimulation. MMN reflects an automatic process of detecting a mismatch between a deviant stimulus and a sensory-memory trace. Smaller amplitudes of MMN have been consistently identified in schizophrenia participants. MMN amplitude will be measured at Midline frontal electrode (Fz) of electroencephalogram [EEG].
Measure: Mean Mismatch Negativity (MMN) at Day 8 Time: Day 8: For each treatment period
Description: The P300 wave is an ERP component that is elicited by the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli in a manner similar to MMN, but requiring active listening and responding from participants. Auditory stimuli are presented in an oddball paradigm consisting of 1 standard tone and 1 target tone. Participants are instructed to push a button as quickly as possible when they hear the target tone, but not when they hear the standard tone. P300 reflects allocation of attention and activation of immediate memory. P300 amplitude indexes brain actions when the mental representation of the stimulus environment is updated, while P300 latency indexes stimulus classification speed unrelated to response selection processes. P300 amplitude will be measured at midline parietal electrode (Pz) of EEG.
Measure: Mean P300 Amplitude at Day 8 Time: Day 8: For each treatment period
Description: ASSR are evoked oscillatory responses that are entrained to the frequency and phase of temporally modulated stimuli. Individuals with schizophrenia experience subjective sensory anomalies and objective deficits on assessment of sensory function. These deficits can be produced by abnormal signaling in the sensory pathways and sensory cortex or by later-stage disturbances in the cognitive processing of such inputs. ASSR can be used to assess the integrity of sensory pathways including cortical processing. ASSR will be measured at midline central electrode (Cz) of EEG.
Measure: Mean Auditory Steady State Response (ASSR) to 40 Hz Stimulation at Day 8 Time: Day 8: For each treatment period
Description: BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant's cognition is compared to a healthy person.
Measure: Brief Assessment of Cognition in Schizophrenia (BACS) Cognitive Battery Composite Score at Day 7 Time: Day 7: For each treatment period
Measure: Mean Concentration of Plasma D-serine and L-serine Levels at Day 8 Time: Day 8: For each treatment period
Measure: Mean Plasma D-serine to Total Serine Ratio at Day 8 Time: Day 8: For each treatment period
Measure: Mean Plasma Concentration of TAK-831 Time: Day 1, 7 and 8: For each treatment period
3 Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial
Primary Outcomes
Description: EBC is a method used to investigate cerebellar function. In EBC, a conditioned stimulus (CS), a tone precedes but co-terminates with an unconditioned stimulus (US), an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response [CR]) occurs prior to the onset of the US. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned).
Measure: Average Percentage of Conditioned Responses During the Eye Blink Conditioning (EBC) Test at Day 8 Time: Day 8: For each treatment periodSecondary Outcomes
Description: MMN is an event related potential (ERP) evoked in response to unattended changes in background stimulation. MMN reflects an automatic process of detecting a mismatch between a deviant stimulus and a sensory-memory trace. Smaller amplitudes of MMN have been consistently identified in schizophrenia participants. MMN amplitude will be measured at Midline frontal electrode (Fz) of electroencephalogram [EEG].
Measure: Mean Mismatch Negativity (MMN) at Day 8 Time: Day 8: For each treatment periodDescription: The P300 wave is an ERP component that is elicited by the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli in a manner similar to MMN, but requiring active listening and responding from participants. Auditory stimuli are presented in an oddball paradigm consisting of 1 standard tone and 1 target tone. Participants are instructed to push a button as quickly as possible when they hear the target tone, but not when they hear the standard tone. P300 reflects allocation of attention and activation of immediate memory. P300 amplitude indexes brain actions when the mental representation of the stimulus environment is updated, while P300 latency indexes stimulus classification speed unrelated to response selection processes. P300 amplitude will be measured at midline parietal electrode (Pz) of EEG.
Measure: Mean P300 Amplitude at Day 8 Time: Day 8: For each treatment periodDescription: ASSR are evoked oscillatory responses that are entrained to the frequency and phase of temporally modulated stimuli. Individuals with schizophrenia experience subjective sensory anomalies and objective deficits on assessment of sensory function. These deficits can be produced by abnormal signaling in the sensory pathways and sensory cortex or by later-stage disturbances in the cognitive processing of such inputs. ASSR can be used to assess the integrity of sensory pathways including cortical processing. ASSR will be measured at midline central electrode (Cz) of EEG.
Measure: Mean Auditory Steady State Response (ASSR) to 40 Hz Stimulation at Day 8 Time: Day 8: For each treatment periodDescription: BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant's cognition is compared to a healthy person.
Measure: Brief Assessment of Cognition in Schizophrenia (BACS) Cognitive Battery Composite Score at Day 7 Time: Day 7: For each treatment periodMeasure: Mean Concentration of Plasma D-serine and L-serine Levels at Day 8 Time: Day 8: For each treatment period
Measure: Mean Plasma D-serine to Total Serine Ratio at Day 8 Time: Day 8: For each treatment period
Measure: Mean Plasma Concentration of TAK-831 Time: Day 1, 7 and 8: For each treatment period
Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 56 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.
NCT04173572 Schizophrenia Schizoaffective Disorder Brief Psychotic Disorder Schizophreniform Disorders Unspecified Schizophrenia Spectrum and Other Psychotic Disorder Behavioral: PACE-Life Behavioral: Exercise Intervention MeSH:Disease Schizophrenia Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders
HPO:Psychosis Schizophrenia
Primary Outcomes
Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Measure: Difference in Participant's Total Distance During 6-minute Walk Time: Baseline and the last study visit (Up to 20 weeks)
Secondary Outcomes
Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Measure: Mean Difference in Minutes Spent Walking Time: Baseline and the last study visit (up to 20 weeks)
Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Measure: Mean Difference in Daily Steps Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Measure: Mean Difference Overall UCLA Loneliness Scale Score Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Measure: Mean Difference Overall PANSS Score Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).
Measure: Mean Difference in Body Weight Change Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).
Measure: Mean difference in blood pressure change Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).
Measure: Mean Difference in Resting Heart Rate Change Time: Baseline and the last study visit (Up to 20 weeks)
Other Outcomes
Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) Time: Baseline and the last study visit (Up to 20 weeks)
Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Measure: Mean Difference in Composite Score on the Autonomy Support Scale Time: Baseline and the last study visit (Up to 20 weeks)
Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Measure: End of Study Survey Time: Post treatment only (16 weeks)
HPO Nodes
HP:0100753: Schizophrenia
Genes 72
MSTO1 PRODH ARSG NKX2-1 DRD3 DNAJC13 PRODH GJA5 SNCA CAT PSAP FLI1 GBA PDZD7 CHI3L1 DAOA LRRK2 SHANK3 MYO7A CIB2 GJA8 WFS1 UPF3B CLRN1 ATP2A2 COMT ARVCF KRT83 TBX1 HTR2A COMT ESPN TRNE KRT86 JMJD1C SYN2 RBM12 DSG4 MSTO1 MED12 ARSA DNMT3A SEC24C KRT81 VPS35 CHRNA7 CEP78 HIRA APOL2 RREB1 MYO7A MTHFR EIF4G1 TBX1 USH2A CDH23 ZDHHC9 GIGYF2 PCDH15 GP1BB USH1C RTN4R USH1G PRODH ADGRV1 HARS1 TBX1 APOL4 UFD1 TRNS2 DISC2 WHRN
Primary Outcomes
Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Measure: Difference in Participant's Total Distance During 6-minute Walk Time: Baseline and the last study visit (Up to 20 weeks)Secondary Outcomes
Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Measure: Mean Difference in Minutes Spent Walking Time: Baseline and the last study visit (up to 20 weeks)Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Measure: Mean Difference in Daily Steps Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Measure: Mean Difference Overall UCLA Loneliness Scale Score Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Measure: Mean Difference Overall PANSS Score Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).
Measure: Mean Difference in Body Weight Change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).
Measure: Mean difference in blood pressure change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).
Measure: Mean Difference in Resting Heart Rate Change Time: Baseline and the last study visit (Up to 20 weeks)Other Outcomes
Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Measure: Mean Difference in Composite Score on the Autonomy Support Scale Time: Baseline and the last study visit (Up to 20 weeks)Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Measure: End of Study Survey Time: Post treatment only (16 weeks)