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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05890183
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 23, 2023
Status verified
Dec 2024
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomization to Combined Cognitive Training and Exercise (CT&E)
    The 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.
  • Active Comparator: Cognitive Training and Healthy Living Group (CT&HLG)
    The 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.

Primary Outcome Measure

Change in Serum Mature BDNF [ Time Frame: Outcome is change from baseline to 2 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Aftercare Research ProgramLos AngelesCalifornia90095-6968
Keith H Nuechterlein, PhD
[email protected]
310-206-3142
Kenneth L Subotnik, PhD
[email protected]
3108250334
Keith H. Nuechterlein, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
UCLA Aftercare Research Program· Los Angeles, CA

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