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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01817387
Other study ID # NIMHK23SCH
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date March 20, 2018

Study information

Verified date January 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date March 20, 2018
Est. primary completion date March 20, 2018
Accepts healthy volunteers No
Gender All
Age group 14 Years to 30 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
PRIME
Mobile application designed to improve psychosocial functioning and motivational deficits
Cognitive Training
Auditory processing, verbal learning, memory, processing speed, and social cognition

Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychosocial functioning Work status, work performance, social status, social performance, health status, health performance past 30 days
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