Enhancing Motivation in Recent Onset Schizophrenia

Study Overview
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Brief Summary
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This project will result in the development of a personalized intervention strategy to improve motivation for treatment engagement and functional outcomes in individuals with a recent onset of schizophrenia. Motivational impairment is arguably the single most important factor that determines a patient's ability to engage in and adhere to effective treatment. In our study, sixty participants will be enrolled in a randomized controlled trial comparing the feasibility and tolerability of two types of motivational interventions (Daily Goals or PRIME), and a neuroplasticity-based cognitive training program. Participants are randomized to either receive Daily Goals or PRIME for 8 weeks, after which, both conditions will also receive an 8-week course of cognitive training delivered via iPads. Participants will undergo pre/post-testing and a 6-month follow-up to determine feasibility and efficacy of the interventions. By enhancing motivation, schizophrenia patients would be able to engage more fully with treatment and develop full and productive lives. This study may also pave the way forward for other health conditions in which motivational impairments impede health outcomes. All assessments will be conducted at the University of California, San Francisco; however, we offer some assessments to be done remotely.

Official Title
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Developing an Intervention Strategy to Enhance Motivation in Recent Onset Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: PRIME
* Behavioral: Cognitive Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder. Onset of diagnosis within 5 years. 14-30 years old. Clinically stable (outpatient status for 1 month and stable dose of medication for 1 month). Good general health Exclusion Criteria: Substance dependence within the past 12 months, Current substance abuse, No history of neurological disorder

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRIME + CT<br>4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training | Behavioral: PRIME<br>* Mobile application designed to improve psychosocial functioning and motivational deficits<br>Behavioral: Cognitive Training<br>* Auditory processing, verbal learning, memory, processing speed, and social cognition<br>|
| Experimental: Daily Goals + CT<br>4 months use of Daily Goals mobile application on mobile device and 30 hours of cognitive training | Behavioral: Cognitive Training<br>* Auditory processing, verbal learning, memory, processing speed, and social cognition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial functioning | Work status, work performance, social status, social performance, health status, health performance | past 30 days |