SchizophreniaPRIMENCT01817387
Enhancing Motivation in Recent Onset Schizophrenia
A study testing PRIME and Cognitive Training in people with Schizophrenia, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PRIME and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 20 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Substance dependence within the past 12 months,
- Current substance abuse,
- No history of neurological disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Developing an Intervention Strategy to Enhance Motivation in Recent Onset Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- PRIME, Cognitive Training
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMEBehavioural
Mobile application designed to improve psychosocial functioning and motivational deficits
Cognitive TrainingBehavioural
Auditory processing, verbal learning, memory, processing speed, and social cognition
| Study group | Role | What they receive |
|---|---|---|
| PRIME + CT | Experimental | 4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training Receives: Behavioral: PRIME; Behavioral: Cognitive Training |
| Daily Goals + CT | Experimental | 4 months use of Daily Goals mobile application on mobile device and 30 hours of cognitive training Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial functioning
Work status, work performance, social status, social performance, health status, health performance
Measured: past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startJul 2014
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Why it stopped: Due to participants not completing the cognitive training requirement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle A Schlosser, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817387
- Sponsor's protocol ID
- NIMHK23SCH
- Acronym
- PRIME
- Status last verified
- Jan 2020
- First submitted
- 13 Mar 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Intervention Strategy to Enhance Motivation in Recent Onset Schizophrenia
- ClinicalTrials.gov ID
- NCT01817387
- Acronym / sponsor ID
- PRIME / NIMHK23SCH
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to participants not completing the cognitive training requirement.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIME + CT | Experimental | Behavioral: PRIME, Behavioral: Cognitive Training4 months use of PRIME mobile application on mobile device and 30 hours of cognitive training |
| Daily Goals + CT | Experimental | Behavioral: Cognitive Training4 months use of Daily Goals mobile application on mobile device and 30 hours of cognitive training |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Substance dependence within the past 12 months,
- Current substance abuse,
- No history of neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIMEMobile application designed to improve psychosocial functioning and motivational deficits | Behavioural | PRIME + CT |
| Cognitive TrainingAuditory processing, verbal learning, memory, processing speed, and social cognition | Behavioural | Daily Goals + CT, PRIME + CT |
Primary outcome
Psychosocial functioning
Time frame: past 30 days
Work status, work performance, social status, social performance, health status, health performance
Results and safety
The study was stopped early (reason given: Due to participants not completing the cognitive training requirement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle A Schlosser, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME and Cognitive Training in people with Schizophrenia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to participants not completing the cognitive training requirement.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial functioning (time frame: past 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.