Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started May 2023
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedStudy Start
First participant enrolled
May 23, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
January 2, 2025
December 1, 2024
5 years
May 9, 2023
December 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Change in Serum Mature BDNF
A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis
Outcome is change from baseline to 2 weeks.
Change in Serum Mature BDNF
A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis
Outcome is change from baseline to 3 months.
Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)
A summary of overall cognitive performance on the MATRICS Consensus Cognitive Battery
Outcome is change from baseline to 3 months.
Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)
A summary of overall cognitive performance on the MATRICS Consensus Cognitive Battery
Outcome is change from baseline to 6 months.
Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
21 items that assess motivational experiences in three domains: Interest/enjoyment, perceived choice, and value/usefulness.
Outcome is change from baseline to 3 months.
Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
21 items that assess motivational experiences in three domains: Interest/enjoyment, perceived choice, and value/usefulness.
Outcome is change from baseline to 6 months.
Attendance at Exercise Sessions for First Three Months
Proportion of group sessions completed by the participants in the exercise group
First Three Months After Baseline
Attendance at Exercise Sessions for First Six Months
Proportion of group sessions completed by the participants in the exercise group
First Six Months After Baseline
Study Arms (2)
Randomization to Combined Cognitive Training and Exercise (CT&E)
EXPERIMENTALThe 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.
Cognitive Training and Healthy Living Group (CT&HLG)
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA Aftercare Research Program
Los Angeles, California, 90095-6968, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith H Nuechterlein, PhD
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- An assessor of functional outcome will be blind to treatment condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2023
First Posted
June 6, 2023
Study Start
May 23, 2023
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
January 2, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share