Enhancing Motivation in Recent Onset Schizophrenia

Not Applicable

Terminated

• Conditions: Schizophrenia
• Interventions: Behavioral: PRIME; Behavioral: Cognitive Training

• Registration Number: NCT01817387
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-25
• Study Start: 2014-07
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PRIME + CT	PRIME	4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training
PRIME + CT	Cognitive Training	4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training
Daily Goals + CT	Cognitive Training	4 months use of Daily Goals mobile application on mobile device and 30 hours of cognitive training

Primary Outcome Measures

Name	Time	Method
Psychosocial functioning	past 30 days	Work status, work performance, social status, social performance, health status, health performance

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States