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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 outcome is change from baseline to 3 months.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome is change from baseline to 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome is change from baseline to 6 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,168 Total Patients Enrolled
38 Trials studying Schizophrenia
4,790 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,609 Total Patients Enrolled
249 Trials studying Schizophrenia
89,335 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder.I am fluent in English and understand the culture well.I am between 18 and 45 years old.I have a known neurological disorder or have had a significant head injury.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Training and Healthy Living Group (CT&HLG)
- Group 2: Randomization to Combined Cognitive Training and Exercise (CT&E)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any specific demographics that are more suitable to join this medical study?
"Patients with schizophrenia aged 18 to 45 are eligible for admission into this clinical trial, of which 100 participants will be enrolled."
Answered by AI
Does this research accommodate individuals aged sixty or above?
"The age restrictions for this study mandate that applicants are between 18 and 45 years old. Conversely, there are 335 studies available to minors and 838 trials open to seniors."
Answered by AI
Does this experiment have capacity for new participants?
"Affirmative, clinicaltrials.gov attests that this investigation is actively recruiting patients as of May 25th 2023. The trial was posted on the 23rd and seeks 100 volunteers from a single medical site."
Answered by AI
What is the current enrollment size for this clinical trial?
"Affirmative. The information posted on clinicaltrials.gov attests to the fact that this medical trial, which was initially created on May 23rd 2023, is currently searching for participants. 100 individuals need to be recruited from 1 site in order for the study to proceed."
Answered by AI
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