NCT01817387

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

3.7 years

First QC Date

March 13, 2013

Last Update Submit

January 21, 2020

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Psychosocial functioning

    Work status, work performance, social status, social performance, health status, health performance

    past 30 days

Study Arms (2)

PRIME + CT

EXPERIMENTAL

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

Behavioral: PRIMEBehavioral: Cognitive Training

Daily Goals + CT

EXPERIMENTAL

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

Behavioral: Cognitive Training

Interventions

PRIMEBEHAVIORAL

Mobile application designed to improve psychosocial functioning and motivational deficits

PRIME + CT
Cognitive TrainingBEHAVIORAL

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

Daily Goals + CTPRIME + CT

Eligibility Criteria

Age14 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder.
  • Onset of diagnosis within 5 years.
  • years old.
  • Clinically stable (outpatient status for 1 month and stable dose of medication for 1 month).
  • Good general health

You may not qualify if:

  • Substance dependence within the past 12 months,
  • Current substance abuse,
  • No history of neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Danielle A Schlosser, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 25, 2013

Study Start

July 1, 2014

Primary Completion

March 20, 2018

Study Completion

March 20, 2018

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)