Treatment Development Targeting Severe and Persistent Negative Symptoms (MOVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dawn Velligan, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01550666
First received: February 15, 2012
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Schizophrenia
Behavioral: MOVE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Treatment Development Targeting Severe and Persistent Negative Symptoms

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Changes in Negative Symptoms [ Time Frame: 9 months after treatment ] [ Designated as safety issue: No ]
    During these times an assessor will ask questions regarding negative symptoms


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MOVE
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
Behavioral: MOVE
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
No Intervention: Treatment As Usual
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Receiving treatment with antipsychotic medication
  3. 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)
  4. 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
  5. 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
  6. No more than mild depression as indicated by a score of 3 or lower on the BPRS
  7. No significant movement disorder as indicated by a score of 3 or lower on the ESRS-A
  8. 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:

  1. History of significant head trauma
  2. History of a seizure disorder
  3. Mental Retardation
  4. Alcohol or drug abuse or dependence within the past 3 months
  5. History of violence in the past one year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550666

Contacts
Contact: Elisa M Medellin, M.A. 210-562-5262 medelline2@uthscsa.edu

Locations
United States, Texas
The Center for Health Care Services Recruiting
San Antonio, Texas, United States, 78201
Contact: Lisa Longoria, B.A.    210-562-5264    longorial3@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Dawn I Velligan, Ph.D. The UT Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Dawn Velligan, Professor/Clinical Psychiatry, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01550666     History of Changes
Other Study ID Numbers: HSC20110149H, R34MH093483-01
Study First Received: February 15, 2012
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by The University of Texas Health Science Center at San Antonio:
negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014