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Enhancing Motivation in Recent Onset Schizophrenia (PRIME)

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRIME
Cognitive Training
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PRIME + CT

Daily Goals + CT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Psychosocial functioning
Work status, work performance, social status, social performance, health status, health performance

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
January 21, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01817387
Brief Title
Enhancing Motivation in Recent Onset Schizophrenia
Acronym
PRIME
Official Title
Developing an Intervention Strategy to Enhance Motivation in Recent Onset Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to participants not completing the cognitive training requirement.
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRIME + CT
Arm Type
Experimental
Arm Description
4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training
Arm Title
Daily Goals + CT
Arm Type
Experimental
Arm Description
4 months use of Daily Goals mobile application on mobile device and 30 hours of cognitive training
Intervention Type
Behavioral
Intervention Name(s)
PRIME
Intervention Description
Mobile application designed to improve psychosocial functioning and motivational deficits
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Auditory processing, verbal learning, memory, processing speed, and social cognition
Primary Outcome Measure Information:
Title
Psychosocial functioning
Description
Work status, work performance, social status, social performance, health status, health performance
Time Frame
past 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle A Schlosser, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://drive.ucsf.edu/
Description
Lab website

Learn more about this trial

Enhancing Motivation in Recent Onset Schizophrenia

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