RecruitingNot Applicable

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

United States100 participantsStarted 2023-05-23

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Serum Mature BDNF

Timeframe: Outcome is change from baseline to 2 weeks.

Change in Serum Mature BDNF

Timeframe: Outcome is change from baseline to 3 months.

Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)

Timeframe: Outcome is change from baseline to 3 months.

Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)

Timeframe: Outcome is change from baseline to 6 months.

Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)

Timeframe: Outcome is change from baseline to 3 months.

Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)

Timeframe: Outcome is change from baseline to 6 months.

Attendance at Exercise Sessions for First Three Months

Timeframe: First Three Months After Baseline

Trial details

NCT IDNCT05890183

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Rebecca Zornitsky, MSc

(424) 225-1779 RZornitsky@mednet.ucla.edu

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Serum Mature BDNF

Timeframe: Outcome is change from baseline to 2 weeks.

Change in Serum Mature BDNF

Timeframe: Outcome is change from baseline to 3 months.

Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)

Timeframe: Outcome is change from baseline to 3 months.

Change in Overall Composite T-score from the MATRICS Consensus Cognitive Battery (MCCB)

Timeframe: Outcome is change from baseline to 6 months.

Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)

Timeframe: Outcome is change from baseline to 3 months.

Change in Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)

Timeframe: Outcome is change from baseline to 6 months.

Attendance at Exercise Sessions for First Three Months

Timeframe: First Three Months After Baseline