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A System for Preference Assessment in Mental Health (SPA)

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ClinicalTrials.gov Identifier: NCT02183844
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Los Angeles County Department of Public Health
Los Angeles County Department of Mental Health
Information provided by (Responsible Party):
Alexander S. Young, MD MSHS, University of California, Los Angeles

Brief Summary:
It is important that individuals with serious mental illness make informed choices among alternative healthcare treatments based on their preferences. However, at present, individuals' preferences are often not being elicited, nor used to guide which treatments are made available. In this pilot project, the investigators implement and evaluate a computerized method for assessing treatment preferences of individuals with schizophrenia. The investigators use weight management treatments for this initial test of the system. If this assessment method is found to predict treatment use and satisfaction, it can be used to guide implementation of treatments that improve outcomes while meeting individuals' preferences.

Condition or disease Intervention/treatment Phase
Mental Disorders Schizophrenia Overweight Obesity Behavioral: Psychosocial Weight Intervention Not Applicable

Detailed Description:

Background/Rationale: It is important that individuals with serious mental illness have access to treatments that meet their preferences, and that they make informed choices among alternative treatments. Too often, preferences are not being routinely elicited, nor used to guide which treatments are made available. Schizophrenia is a serious mental illness that is common and produces substantial disability when poorly treated. National treatment guidelines specify that individuals with schizophrenia should receive evidence-based treatments that improve outcomes. For example, obesity is a pressing problem in this population, a side-effect of commonly used medications, and a cause of cardiovascular disease and premature mortality. There are multiple, different psychosocial interventions for weight management that can lead to reduced weight. None are widely used. If individuals' preferences were routinely assessed, then clinicians and managers would know when to make alternative treatments available.

Objectives: This project implements and evaluates a method for routinely assessing the treatment preferences of individuals with schizophrenia. The objectives are to: 1) develop a computerized, kiosk-based system that delivers education regarding treatment options for weight, uses conjoint analysis to elicit preferences, and meets the cognitive needs of individuals with schizophrenia; 2) study the feasibility and acceptability of implementing this method at a mental health clinic; and, 3) evaluate the extent to which this method predicts use of evidence-based weight services, and satisfaction with services at three months.

Methods: This is a prospective evaluation of preferences, treatment use, and satisfaction in individuals with schizophrenia. 94 individuals are enrolled who are overweight and receiving treatment at a busy, urban mental health clinic. These participants use a kiosk system that provides them with education about treatment options, and assesses their preferences regarding alternative treatments for weight. They are then offered a weekly, intensive, evidence-based psychosocial treatment for weight. Research assessments occur at baseline and 3 months. Treatment preferences are analyzed to determine how they relate to use of weight treatment, and satisfaction with treatment.

Significance: People with serious mental illness could benefit from access to effective treatments. Implementing these treatments would be facilitated by routinely collecting information regarding individuals' preferences. If the assessment method in this study is found to be feasible, acceptable, and accurate, it could be used to support implementation of improved care at clinics, medical centers, and community-based programs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing Patient-Centered Decision Support for Mental Health
Actual Study Start Date : June 16, 2014
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psychosocial Weight Intervention
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
Behavioral: Psychosocial Weight Intervention
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses




Primary Outcome Measures :
  1. Days until using weight services [ Time Frame: 3 months ]
    Utilization of the weight services offered. This includes the number of days until starting to use weight services. This is assessed using information regarding attendance at weight services, and by survey administered by interview.

  2. Participant preferences regarding weight services [ Time Frame: Baseline ]
    Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.

  3. Satisfaction with the weight services provided [ Time Frame: 3 months ]
    Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.

  4. Number of weight services used [ Time Frame: 3 months ]
    Utilization of the weight services offered. This includes the number of weight service sessions attended. This is assessed using information regarding attendance at weight services, and by survey administered by interview.


Secondary Outcome Measures :
  1. Feasibility and acceptability of implementing preference assessment [ Time Frame: Baseline ]
    Feasibility and acceptability of implementing kiosk-based preference assessment at a mental health clinic. This is assessed using project records, surveys, and semi-structured interview questions assessing whether participants and staff find the program and its components to be advantageous, relevant, simple, easy to use, and beneficial.


Other Outcome Measures:
  1. Aspects of the Theory of Planned Behavior [ Time Frame: Baseline and 3 months ]
    Attitudes, subjective norms, perceived control, and behavioral intentions regarding weight loss. These are assessed by interview, using scales from the Theory of Planned Behavior.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of schizophrenia
  2. age 18 or older
  3. Body Mass Index (BMI) of either 28.0-29.9 and gained 10 pounds in the last 3 months; OR, BMI of 30 or above
  4. able to provide informed consent

Exclusion Criteria:

  1. a medical condition for which a weight program is contraindicated
  2. pregnant and nursing mothers
  3. attendance at a psychosocial intervention for weight management in the past month
  4. individuals with legal conservators who manage informed consent
  5. can not speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183844


Locations
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United States, California
UCLA Center for Health Services and Society
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles County Department of Public Health
Los Angeles County Department of Mental Health
Investigators
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Principal Investigator: Alexander S Young, MD, MSHS University of California, Los Angeles

Publications:
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Responsible Party: Alexander S. Young, MD MSHS, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02183844    
Other Study ID Numbers: R21MH100565 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander S. Young, MD MSHS, University of California, Los Angeles:
Medical Informatics
Patient-Centered
Healthcare Preferences
Health Education
Quality Improvement
Weight Loss
Personal Satisfaction
Humans
Cognition
Body Weight
Additional relevant MeSH terms:
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Overweight
Schizophrenia
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Body Weight
Signs and Symptoms