SchizophreniaMOVENCT01550666
Treatment Development Targeting Severe and Persistent Negative Symptoms
A study testing MOVE in people with Schizophrenia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
People with schizophrenia often have problems with negative symptoms; expressing and identifying their emotions, their amount of speech, motivation and interests, feelings of purpose, social skills, and experiencing enjoyment. For this reason, new interventions are being developed to treat these problems. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MOVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2015
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female between the 18-60 who meet DSM-IV criteria for schizophrenia confirmed by the Structured Clinical Interview Diagnosis (SCID-P version). Outpatient status.
- Receiving treatment with antipsychotic medication
- Clinically stable for a minimum of 5 months prior to screening (no significant changes in schizophrenia symptomatology, depressive symptoms, or community functioning, no hospitalizations, emergency visits or incarceration due to symptoms of schizophrenia or depression, no medication increases due to symptom exacerbation)
- Has clinically meaningful negative symptoms as indicted by a score of 4 or higher on at least 2 of 6 of the following symptom domains as rated by the NSA-16; restricted affect, diminished emotional range, poverty of speech, curbing of interest, diminished sense of purpose, and diminished social drive
- No more than moderate positive symptoms as indicated by a score of 5 or lower on BPRS-E items measuring delusions and hallucinations and no more than a 4 or higher on conceptual disorganization
- No more than mild depression as indicated by a score of 3 or lower on the BPRS
- No significant movement disorder as indicated by a score of 3 or lower on the ESRS-A
- Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility with no plans to move in the next year)
Who cannot join
- History of significant head trauma
- History of a seizure disorder
- Mental Retardation
- Alcohol or drug abuse or dependence within the past 3 months
- History of violence in the past one year
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Health Care Services
San Antonio, Texas, 78201
About this study
People with schizophrenia often have problems with negative symptoms; expressing and identifying their emotions, their amount of speech, motivation and interests, feelings of purpose, social skills, and experiencing enjoyment. For this reason, new interventions are being developed to treat these problems. One new intervention is the Motivation and Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly meetings for 9 months between a patient and a trainer. The weekly meetings will consist of goal setting and organization of the home to make daily tasks more manageable. During the weekly meetings the patient and trainer will discuss emotions and the trainer will help the patient identify their emotions.
The researchers hope to learn whether MOVE will help improve the problems. If it works the researchers will do a larger study comparing MOVE to other treatments that have addressed some of the problems already.
The therapist will ask you if the sessions can be audio taped to ensure that the therapist is doing a helpful job for you. They will also ask if the session can be video taped so that the tapes can be used to train other therapists learning about MOVE. The choice to do either of these is voluntary and you can continue to participate in the study if you choose not to have the session be audio and/or video taped.You will be provided a University Release document to provide that permission if you so choose.
- Conditions
- Schizophrenia
- Being tested
- MOVE
- Keywords
- negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVEBehavioural
MOVE Program group: MOVE consists of medication follow-up at the CHCS or ATCMHMR and meeting once a week for 9 months with a MOVE trainer in your home. You and your trainer will work on interviews for the first three visits that will talk about negative symptoms, thoughts, attitudes, and social skills that will help each of you develop goals together. Activities will be developed around improving initiation, enjoyment, success and outcome. These activities will be customized to you and will change based on your needs weekly throughout the 9 months
| Study group | Role | What they receive |
|---|---|---|
| MOVE | Experimental | MOVE Program group: MOVE consists of medication follow-up at the CHCS or ATCMHMR and meeting once a week for 9 months with a MOVE trainer in your home. You and your trainer will work on interviews for the first three visits that will talk about negative symptoms, thoughts, attitudes, and social skills that will help each of you develop goals together. Activities will be developed around improving initiation, enjoyment, success and outcome. These activities will be customized to you and will change based on your needs weekly throughout the 9 months Receives: Behavioral: MOVE |
| Treatment As Usual | No intervention | Participants of this group will continue to receive medication follow up at the Center for Health Care Services. They will not be required to do anything additional except to complete assessment visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Negative Symptoms
During these times an assessor will ask questions regarding negative symptoms
Measured: 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionJan 2015
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dawn Velligan, The University of Texas Health Science Center at San Antonio
- Investigators
- Dawn I Velligan, Ph.D., Principal investigator, The UT Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550666
- Sponsor's protocol ID
- HSC20110149H
- Other IDs
- R34MH093483-01
- Acronym
- MOVE
- Status last verified
- Jan 2016
- First submitted
- 15 Feb 2012
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Development Targeting Severe and Persistent Negative Symptoms
- ClinicalTrials.gov ID
- NCT01550666
- Acronym / sponsor ID
- MOVE / HSC20110149H
- Conditions
- Schizophrenia
- Keywords
- negative symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Mar 2012 (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.
People with schizophrenia often have problems with negative symptoms; expressing and identifying their emotions, their amount of speech, motivation and interests, feelings of purpose, social skills, and experiencing enjoyment. For this reason, new interventions are being developed to treat these problems. One new intervention is the Motivation and Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly meetings for 9 months between a patient and a trainer. The weekly meetings will consist of goal setting and organization of the home to make daily tasks more manageable. During the weekly meetings the patient and trainer will discuss emotions and the trainer will help the patient identify their emotions.
The researchers hope to learn whether MOVE will help improve the problems. If it works the researchers will do a larger study comparing MOVE to other treatments that have addressed some of the problems already.
The therapist will ask you if the sessions can be audio taped to ensure that the therapist is doing a helpful job for you. They will also ask if the session can be video taped so that the tapes can be used to train other therapists learning about MOVE. The choice to do either of these is voluntary and you can continue to participate in the study if you choose not to have the session be audio and/or video taped.You will be provided a University Release document to provide that permission if you so choose.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOVE | Experimental | Behavioral: MOVEMOVE Program group: MOVE consists of medication follow-up at the CHCS or ATCMHMR and meeting once a week for 9 months with a MOVE trainer in your home. You and your trainer will work on interviews for the first three visits that will talk about negative symptoms, thoughts, attitudes, and social skills that will help each of you develop goals together. Activities will be developed around improving initiation, enjoyment, success and outcome. These activities will be customized to you and will change based on your needs weekly throughout the 9 months |
| Treatment As Usual | No intervention | –Participants of this group will continue to receive medication follow up at the Center for Health Care Services. They will not be required to do anything additional except to complete assessment visits. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female between the 18-60 who meet DSM-IV criteria for schizophrenia confirmed by the Structured Clinical Interview Diagnosis (SCID-P version). Outpatient status.
- Receiving treatment with antipsychotic medication
- Clinically stable for a minimum of 5 months prior to screening (no significant changes in schizophrenia symptomatology, depressive symptoms, or community functioning, no hospitalizations, emergency visits or incarceration due to symptoms of schizophrenia or depression, no medication increases due to symptom exacerbation)
- Has clinically meaningful negative symptoms as indicted by a score of 4 or higher on at least 2 of 6 of the following symptom domains as rated by the NSA-16; restricted affect, diminished emotional range, poverty of speech, curbing of interest, diminished sense of purpose, and diminished social drive
- No more than moderate positive symptoms as indicated by a score of 5 or lower on BPRS-E items measuring delusions and hallucinations and no more than a 4 or higher on conceptual disorganization
Key exclusion criteria (5 listed)
- History of significant head trauma
- History of a seizure disorder
- Mental Retardation
- Alcohol or drug abuse or dependence within the past 3 months
- History of violence in the past one year
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 |
|---|---|---|
| MOVEMOVE Program group: MOVE consists of medication follow-up at the CHCS or ATCMHMR and meeting once a week for 9 months with a MOVE trainer in your home. You and your trainer will work on interviews for the first three visits that will talk about negative symptoms, thoughts, attitudes, and social skills that will help each of you develop goals together. Activities will be developed around improving initiation, enjoyment, success and outcome. These activities will be customized to you and will change based on your needs weekly throughout the 9 months | Behavioural | MOVE |
Primary outcome
Changes in Negative Symptoms
Time frame: 9 months after treatment
During these times an assessor will ask questions regarding negative symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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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.
Dawn I Velligan, Ph.D. principal investigator
The UT Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE in people with Schizophrenia, run by The University of Texas Health Science Center at San Antonio 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Negative Symptoms (time frame: 9 months after treatment). 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 12 Jan 2016.