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Synergistic Effects of Exercise and Cognitive Remediation on Cognitive Functioning in Schizophrenia and Bipolar DisorderCo-Principal Investigators: Michael Otto, Ph.D. & Susan McGurk, Ph.D.Co-Investigators: Kim Mueser, Ph.D., Lenny Mulcahy, B.A., Stacey Zawacki, Dori Hutchinson, Sc.D., Larry Kohn, M.A.Project Coordinator: Snigdha Talluri, M.A.Center for Psychiatric Rehabilitation, Boston UniversityBackground and Rationale: Problems with cognitive functioning in areas such as attention, concentration, and memory are a common in people with a serious mental illness, and can interfere with achieving their personal goals. Research has shown that cognitive remediation (including coaching on computerized cognitive exercises) improves cognitive functioning, and social and vocational functioning. There is also evidence that physical exercise (such as brisk walking or jogging) improves cognitive functioning, which is believed to be due to its effects on increasing enhanced brain-derived neurotrophic factor (BDNF), a protein that is vital to the health of neurons and promotes brain plasticity. However, little research has explored the benefits of combining exercise with cognitive remediation in people with a serious mental illness.Purpose of Study: This study is aimed at evaluating whether adding a peer-led exercise program to a standardized cognitive remediation program improves cognitive functioning more than providing cognitive remediation alone. The study will also explore whether any greater improvements in cognitive functioning related to exercise are associated with increases in BDNF, as measured by laboratory tests of blood samples.Study Design and Methods: A randomized controlled trial is being conducted in which 50 people with serious mental illness are randomly assigned (by chance) to either receive a standardized computer-based cognitive remediation program alone, or the same cognitive remediation program + a peer-run physical exercise program designed to promote cardiovascular fitness. Both programs are held on the same days, and involve three sessions per week for 10 weeks. All study participants receive a free healthy lunch or snack before cognitive remediation sessions. Interview-based assessments of cognitive functioning and symptoms are conducted at baseline, after the end of the program (Week 11), and 2 weeks later (Week 13). BDNF levels are measured from blood samples obtained at baseline, 5-weeks into the study, and at the end of the 10-week study period. All participants are also given a “Fitbit” to record their activity levels (steps) during the study, which they return at the end of the study. Payment for Assessments: Study participants are paid for completing the cognitive and symptom assessments, and for providing blood samples to measure BDNF levels. Participants are also paid for returning the Fitbit at the end of the study. Participants are not paid for involvement in the cognitive remediation or exercise programs. The payment for the assessments is as follows:Baseline: Interviews and BDNF (1 blood test)$60Mid (Week 5): Brief Interview and BDNF (2 blood tests)$50Post (Week 10): Interviews and BDNF (2 blood tests)$50Post (Week 10): Return Fitbit$25Post (Week 11): Interviews Only$40Follow-up (Week 12): Interviews Only$40TOTAL$265Study Eligibility CriteriaDiagnosis of schizophrenia, schizoaffective disorder, or bipolar disorderMedical clearance from physician to participate in exercise programNot currently exercising regularlyNot pregnant, breastfeeding, or planning on getting pregnantNo current drug or alcohol use disorderReferrals to StudyPersons interested in participating in the study should contact Stephanie Cummings (direct line: 617-353-1124; CPR #: 617-353-3549;?stephc13@bu.edu).For more information about study-related details, please contact Snigdha Talluri, the study coordinator (617-353-3549;?snigdhat@bu.edu) or Deborah Bennett (deborah850@).For any other questions, please contact Michael Otto (mwotto@bu.edu), Susan McGurk (mcgurk@bu.edu), or Kim Mueser (mueser@bu.edu). ................
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