Enhancing Motivation in Recent Onset Schizophrenia

NCT ID: NCT01817387

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-03-20

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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRIME + CT

4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training

Group Type EXPERIMENTAL

PRIME

Intervention Type BEHAVIORAL

Mobile application designed to improve psychosocial functioning and motivational deficits

Cognitive Training

Intervention Type BEHAVIORAL

Auditory processing, verbal learning, memory, processing speed, and social cognition

Daily Goals + CT

4 months use of Daily Goals mobile application on mobile device and 30 hours of cognitive training

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

Auditory processing, verbal learning, memory, processing speed, and social cognition

Interventions

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PRIME

Mobile application designed to improve psychosocial functioning and motivational deficits

Intervention Type BEHAVIORAL

Cognitive Training

Auditory processing, verbal learning, memory, processing speed, and social cognition

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle A Schlosser, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NIMHK23SCH

Identifier Type: -

Identifier Source: org_study_id

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