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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of California, Los Angeles

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Cognitive training

    Behavioral

    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 Program

    Behavioral

    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)

    Behavioral

    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 Program

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Randomization to Combined Cognitive Training and Exercise (CT&E)Experimental treatment 4 interventions
Group B: Cognitive Training and Healthy Living Group (CT&HLG)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in Serum Mature BDNF

A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis

Time frame
Outcome is change from baseline to 2 weeks.
2

Change in Serum Mature BDNF

A brain neurotrophic factor that stimulates synaptic plasticity and neurogenesis

Time frame
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

Time frame
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

Time frame
Outcome is change from baseline to 6 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator