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Telehealth Aerobic Exercise & Cognitive Training for Schizophrenia

N/A
Recruiting
Led By Keith H Nuechterlein, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first three months after baseline
Awards & highlights

Summary

This trial will test if exercise & cognitive training can help improve cognition & engagement in psychiatric treatment. It will use video conferencing & tailored text reminders to motivate & maximize participation.

Who is the study for?
This trial is for individuals aged 18-45 who have experienced their first psychotic episode within the last two years and are diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder. Participants should be fluent in English, live near UCLA's Aftercare Research Program, and be able to commute there.
What is being tested?
The study tests if cognitive training combined with either aerobic exercise or a Healthy Living Group improves cognition in patients after a first schizophrenia episode. It measures engagement levels and brain changes indicating neuroplasticity through serum BDNF levels. The program is delivered via videoconferencing to test its wider applicability.
What are the potential side effects?
Since this trial involves non-pharmaceutical interventions like exercise and cognitive training, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. Psychological support programs typically do not have physical side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome is change from baseline to 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome is change from baseline to 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Attendance at Exercise Sessions for First Six Months
Attendance at Exercise Sessions for First Three Months
Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Randomization to Combined Cognitive Training and Exercise (CT&E)Experimental Treatment4 Interventions
The primary interventions for this arm of the protocol are Cognitive Training and Exercise sessions. The Cognitive Training will be conducted in a group format using Zoom videoconferencing, with participants logging into their individual Posit Science cognitive training accounts. The Aerobic Exercise Program will consist of a physical exercise intervention of 150 minutes/week of moderate aerobic activity, over 4 days, including two group sessions (45 min duration) and two individual sessions (30 min duration in the heart rate zone), for 6 months. After the first 6 months, the group sessions will be once a week with the continuing goal of 150 minutes/week of moderate exercise.
Group II: Cognitive Training and Healthy Living Group (CT&HLG)Active Control3 Interventions
The primary interventions for this arm of the protocol are Cognitive Training and the Healthy Living Group. The Cognitive Training will be conducted in a group format using Zoom videoconferencing, with participants logging into their individual Posit Science cognitive training accounts. The participants in this arm will also participate in a Healthy Living Group, which is a didactic, educational and interactive group that is designed to offer very useful information and discussion of topics that are relevant to a healthy lifestyle. It includes manualized modules devoted to wellness, nutrition, insight, recovery, independent living, social skills, and hobbies. It meets 2 times/week for 6 months and then once a week for the next 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive training
2019
Completed Phase 3
~1480
Aerobic Exercise Program
2007
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,554 Previous Clinical Trials
10,264,014 Total Patients Enrolled
38 Trials studying Schizophrenia
4,767 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,436 Total Patients Enrolled
253 Trials studying Schizophrenia
89,824 Patients Enrolled for Schizophrenia
Keith H Nuechterlein, PhDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
87 Total Patients Enrolled
1 Trials studying Schizophrenia
87 Patients Enrolled for Schizophrenia

Media Library

Aerobic Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT05890183 — N/A
Schizophrenia Research Study Groups: Cognitive Training and Healthy Living Group (CT&HLG), Randomization to Combined Cognitive Training and Exercise (CT&E)
Schizophrenia Clinical Trial 2023: Aerobic Exercise Program Highlights & Side Effects. Trial Name: NCT05890183 — N/A
Aerobic Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05890183 — N/A
~67 spots leftby May 2028
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