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SchizophreniaNCT05890183

Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode

A study testing Cognitive training, Aerobic Exercise Program and Moderated Online Social Therapy (MOST) in people with Schizophrenia and Schizophreniform Disorder, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Cognitive training, Aerobic Exercise Program and Moderated Online Social Therapy (MOST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
23 May 2023to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • UCLA Aftercare Research Program

    Los Angeles, California, 90095-6968

    Keith H Nuechterlein, PhD, (310) 206-3142, keithn@ucla.edu

    Kenneth L Subotnik, PhD, 3108250334, ksubotnik@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This R01 confirmatory efficacy clinical trial application involves telehealth delivery of a treatment approach to improving core cognitive deficits in schizophrenia, using an experimental therapeutic design that NIMH has advocated. This telehealth intervention approach combines neurotrophin-releasing aerobic exercise training with neuroplasticity-based cognitive training to enhance the impact of cognitive training on cognition. Telehealth cognitive training and telehealth physical exercise training address the NIMH strategic research priorities for creating innovative interventions that can be "disseminated broadly" and "readily taught to the existing workforce with minimal cost." Cognitive training and physical exercise have each been shown separately to improve cognitive deficits in schizophrenia to some degree, and previous research has shown that, when combined, show promise of improving cognition and work/school functioning more than either treatment alone. Preliminary studies, comparing the combined treatment with cognitive training without aerobic exercise, found evidence of brain-derived neurotrophic factor (BDNF) target engagement, differential improvement in cognition, and prediction of later cognitive outcome from initial BDNF gain. The portability of the proposed intervention outside of academic research programs will be demonstrated by providing the interventions via videoconferencing. The proposed study will incorporate additional methods, such as Fitbit wrist-worn fitness trackers, web-based motivational support, and personalized text messages to encourage motivation and to maximize participation in the exercise condition. Mature BDNF will serve as the primary target and cognition will serve as the primary outcome. It is hypothesized that the increases in Mature BDNF associated with regular aerobic exercise provide a platform which allows neuroplasticity-based cognitive training to enhance cognition more quickly than is typically observed in studies of cognitive training alone. It is hypothesized that combining aerobic exercise with cognitive training will produce larger cognitive improvements, relative to cognitive training without exercise, with all interventions conducted remotely via videoconferencing. Further, it is hypothesized that a greater proportion of exercise sessions completed will be associated with greater cognitive improvement. The research will also test whether intrinsic motivation at baseline and increases in intrinsic motivation over time predict the extent of participation in the telehealth physical exercise program. Cognitive deficits in persons with schizophrenia are a major influence on their everyday functioning in the community. The study targets the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to real-world functional outcome, before chronic disability is established. This telehealth cognitive training plus aerobic exercise clinical trial has the potential to test a hypothesized mechanism of action and to make a meaningful difference in the lives of individuals with severe mental illness.

Being tested
Cognitive training, Aerobic Exercise Program, Moderated Online Social Therapy (MOST), Chorus Participatory Text Messaging Program, Healthy Living Group (HLG)
Keywords
First-Episode Schizophrenia, Cognitive Remediation, Physical Exercise, Brain Derived Neurotrophic Factor, Telehealth Intervention, Moderated Online Social Therapy (MOST), Motivational Text Messaging Program (Chorus)
Medical subject headings
Schizophrenia, Psychotic Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive trainingBehavioural

    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.

  • Aerobic Exercise ProgramBehavioural

    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.

  • Moderated Online Social Therapy (MOST)Behavioural

    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.

  • Chorus Participatory Text Messaging ProgramBehavioural

    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.

  • Healthy Living Group (HLG)Behavioural

    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.

Study groups in NCT05890183
Study groupRoleWhat they receive
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.
Receives: Behavioral: Cognitive training; Behavioral: Aerobic Exercise Program; Behavioral: Moderated Online Social Therapy (MOST); Behavioral: Chorus Participatory Text Messaging Program
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.
Receives: Behavioral: Cognitive training; Behavioral: Moderated Online Social Therapy (MOST); Behavioral: Healthy Living Group (HLG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Serum Mature BDNF

    A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis

    Measured: Outcome is change from baseline to 2 weeks.

  2. Change in Serum Mature BDNF

    A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis

    Measured: Outcome is change from baseline to 3 months.

  3. 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

    Measured: Outcome is change from baseline to 3 months.

  4. 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

    Measured: Outcome is change from baseline to 6 months.

  5. 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.

    Measured: Outcome is change from baseline to 3 months.

  6. 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.

    Measured: Outcome is change from baseline to 6 months.

  7. Attendance at Exercise Sessions for First Three Months

    Proportion of group sessions completed by the participants in the exercise group

    Measured: First Three Months After Baseline

  8. Attendance at Exercise Sessions for First Six Months

    Proportion of group sessions completed by the participants in the exercise group

    Measured: First Six Months After Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start23 May 2023
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization to Combined Cognitive Training and Exercise (CT\&E) vs. Cognitive Training and Healthy Living Group (CT\&HLG)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890183
Sponsor's protocol ID
R01MH130848
Other IDs
R01MH130848
Status last verified
Aug 2026
First submitted
9 May 2023
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive training, Aerobic Exercise Program and Moderated Online Social Therapy (MOST) in people with Schizophrenia and Schizophreniform Disorder, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danielle Denenny, PhD ((323) 475-8252, Ddenenny@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Mature BDNF (time frame: Outcome is change from baseline to 2 weeks.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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