NCT05890183 Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode
| NCT ID | NCT05890183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-05-23 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. a first episode of a psychotic illness that began within the past three years; 2. a diagnosis by DSM-5 of schizophrenia, schizoaffective disorder, or schizophreniform disorder; 3. age 18 to 45 years of age; 4. sufficient acculturation and fluency in the English language to avoid invalidating research measures; and 5. residence likely to be within commuting distance of the UCLA Aftercare Research Program. Exclusion Criteria: 1. premorbid IQ less than 70; 2. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury; 3. 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 & Investigator
Keith H Nuechterlein, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05890183 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05890183 currently recruiting?
Yes, NCT05890183 is actively recruiting participants. Contact the research team at RZornitsky@mednet.ucla.edu for enrollment information.
Where is the NCT05890183 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05890183 clinical trial?
NCT05890183 is sponsored by University of California, Los Angeles. The principal investigator is Keith H Nuechterlein, PhD at University of California, Los Angeles. The trial plans to enroll 100 participants.
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