Developing an Intervention Strategy to Enhance Motivation in Recent Onset Schizophrenia

Enhancing Motivation in Recent Onset Schizophrenia

Sponsors

Lead sponsor: University of California, San Francisco

Source 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.

Overall Status Terminated
Start Date July 2014
Completion Date March 20, 2018
Primary Completion Date March 20, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Psychosocial functioning past 30 days
Enrollment 20
Condition
Intervention

Intervention type: Behavioral

Intervention name: PRIME

Description: Mobile application designed to improve psychosocial functioning and motivational deficits

Arm group label: PRIME + CT

Intervention type: Behavioral

Intervention name: Cognitive Training

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

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

Gender: All

Minimum age: 14 Years

Maximum age: 30 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Danielle A Schlosser, PhD Principal Investigator University of California, San Francisco
Location
facility University of California San Francisco
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: PRIME + CT

Arm group type: Experimental

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

Arm group label: Daily Goals + CT

Arm group type: Experimental

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

Acronym PRIME
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov