NCT05890183 · University of California, Los Angeles
Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode
What this study is about
The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition.
View original scientific description
The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a "bridging" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.
Interventions
BEHAVIORAL
Cognitive training
This systematic cognitive training program will be delivered by telehealth sessions in which each patient logs into their Posit Science account and joins a Zoom videoconference with 4-8 other patients and two cognitive coaches. The first 12 weeks focus on neurocognitive training and the second 12 weeks focus on social cognitive training. Patients have two CT sessions on each of two days each week to complete 4 hours/week of computerized cognitive training for the first 6 months. Thus, each patient will receive 48 hours of neurocognitive training and 48 hours of social cognitive training in the first 6 months. In the second 6 months, the number of hours per week is trimmed to half the dosage.
BEHAVIORAL
Aerobic Exercise Program
The Aerobic Exercise Program group sessions will be conducted by Zoom videoconferencing. The group exercise training sessions are a combination of moderate intensity aerobic conditioning (1-min intervals) and moderate to high intensity strength and callisthenic conditioning (1-min intervals). The exercise dosage goal is 150 minutes/week of moderate aerobic activity, over 4 days, including for the first 6 months two group sessions (45 min duration) and two individual sessions personalized to the patient's choice of exercise (30 min duration) in the target heart rate zone. After the first 6 months, the group exercise sessions are once a week but the goal remains 150 minutes/week of moderate exercise.
BEHAVIORAL
Moderated Online Social Therapy (MOST)
MOST combines: (1) evidence-based, interactive, user-directed web-based interventions; (2) secure and supportive peer-to-peer web-based social networking; (3) moderator support; and (4) on-demand web chat with registered clinicians. A Motivation Track on the MOST platform will be used to encourage intrinsic motivation for self-improvement for both groups and, for the CT\&E group, involvement in our exercise program.
BEHAVIORAL
Chorus Participatory Text Messaging Program
The Chorus text messaging program is a web-based application that allows clinicians to create a broad range of automated SMS text messages and interactive voice responses using a simple, accessible graphical user interface. It will target encouragement to exercise and social feedback on completed exercise in the CT\&E group.
BEHAVIORAL
Healthy Living Group (HLG)
The Healthy Living Group (HLG) meets two sessions/week to discuss wellness, nutrition, insight, recovery, independent living, social skills, and hobbies for the first 6 months and then one session/week for the next 6 months.
Primary outcome measures
Change in Serum Mature BDNF
Time frame: Outcome is change from baseline to 2 weeks.
A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis
Change in Serum Mature BDNF
Time frame: Outcome is change from baseline to 3 months.
A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis
Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Outcome is change from baseline to 3 months.
A summary of overall cognitive performance on the MATRICS Consensus Cognitive Battery
Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Outcome is change from baseline to 6 months.
A summary of overall cognitive performance on the MATRICS Consensus Cognitive Battery
Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
Time frame: Outcome is change from baseline to 3 months.
21 items that assess motivational experiences in three domains: Interest/enjoyment, perceived choice, and value/usefulness.
Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
Time frame: Outcome is change from baseline to 6 months.
21 items that assess motivational experiences in three domains: Interest/enjoyment, perceived choice, and value/usefulness.
Attendance at Exercise Sessions for First Three Months
Time frame: First Three Months After Baseline
Proportion of group sessions completed by the participants in the exercise group
Attendance at Exercise Sessions for First Six Months
Time frame: First Six Months After Baseline
Proportion of group sessions completed by the participants in the exercise group
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- a first episode of a psychotic illness that began within the past three years;
- a diagnosis by DSM-5 of schizophrenia, schizoaffective disorder, or schizophreniform disorder;
- age 18 to 45 years of age;
- sufficient acculturation and fluency in the English language to avoid invalidating research measures; and
- residence likely to be within commuting distance of the UCLA Aftercare Research Program.
Exclusion criteria
- premorbid IQ less than 70;
- evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- evidence of moderate or severe substance use disorder within the six months prior to the first episode or evidence of a substance-induced psychosis.
Where
- Los Angeles, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 2, 2025 · Source of record for eligibility and locations