Back to resultsTreatment Development Targeting Severe and Persistent Negative Symptoms (MOVE)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOVE
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia focused on measuring negative symptoms
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- The Center for Health Care Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MOVE
Treatment As Usual
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Changes in Negative Symptoms
During these times an assessor will ask questions regarding negative symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT01550666
First Posted
February 15, 2012
Last Updated
January 8, 2016
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01550666
Brief Title
Treatment Development Targeting Severe and Persistent Negative Symptoms
Acronym
MOVE
Official Title
Treatment Development Targeting Severe and Persistent Negative Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
negative symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOVE
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MOVE
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Negative Symptoms
Description
During these times an assessor will ask questions regarding negative symptoms
Time Frame
9 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn I Velligan, Ph.D.
Organizational Affiliation
The UT Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Health Care Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment Development Targeting Severe and Persistent Negative Symptoms
We'll reach out to this number within 24 hrs