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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

No Placebo-Only Group

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 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.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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