Mental DisordersSPANCT02183844
A System for Preference Assessment in Mental Health
A study testing Psychosocial Weight Intervention in people with Mental Disorders and Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Schizophrenia, Overweight
- What is being tested?
- Psychosocial Weight Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2014to 31 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of schizophrenia
- age 18 or older
- 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
- able to provide informed consent
Who cannot join
- a medical condition for which a weight program is contraindicated
- pregnant and nursing mothers
- attendance at a psychosocial intervention for weight management in the past month
- individuals with legal conservators who manage informed consent
- can not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Health Services and Society
Los Angeles, California, 90024
About this study
Official title: Implementing Patient-Centered Decision Support for Mental Health
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.
Read the 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.
- Conditions
- Mental Disorders, Schizophrenia, Overweight, Obesity
- Being tested
- Psychosocial Weight Intervention
- Keywords
- Medical Informatics, Patient-Centered, Healthcare Preferences, Health Education, Quality Improvement, Weight Loss, Personal Satisfaction, Humans, Cognition, Body Weight
- Medical subject headings
- Mental Disorders, Schizophrenia, Overweight, Obesity, Health Education, Weight Loss, Personal Satisfaction, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Weight InterventionBehavioural
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Weight Intervention | Experimental | Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses Receives: Behavioral: Psychosocial Weight Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days until using weight services
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.
Measured: 3 months
Participant preferences regarding weight services
Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.
Measured: Baseline
Satisfaction with the weight services provided
Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.
Measured: 3 months
Number of weight services used
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.
Measured: 3 months
Secondary outcomes (1)
Feasibility and acceptability of implementing preference assessment
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study start16 Jun 2014
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, Los Angeles County Department of Mental Health
- Responsible party
- Principal investigator, Alexander S. Young, MD MSHS, University of California, Los Angeles
- Investigators
- Alexander S Young, MD, MSHS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183844
- Sponsor's protocol ID
- R21MH100565
- Acronym
- SPA
- Status last verified
- Nov 2017
- First submitted
- 30 Jun 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
PubMed 20658320Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.
PubMed 23407006Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.
PubMed 18279505Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.
PubMed 15491237Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.
PubMed 20591993
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Patient-Centered Decision Support for Mental Health
- ClinicalTrials.gov ID
- NCT02183844
- Acronym / sponsor ID
- SPA / R21MH100565
- Conditions
- Mental Disorders, Schizophrenia, Overweight, Obesity
- Keywords
- Medical Informatics, Patient-Centered, Healthcare Preferences, Health Education, Quality Improvement, Weight Loss, Personal Satisfaction, Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, Los Angeles County Department of Mental Health
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 8 Jul 2014 (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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Weight Intervention | Experimental | Behavioral: Psychosocial Weight InterventionWeekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of schizophrenia
- age 18 or older
- 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
- able to provide informed consent
Key exclusion criteria (5 listed)
- a medical condition for which a weight program is contraindicated
- pregnant and nursing mothers
- attendance at a psychosocial intervention for weight management in the past month
- individuals with legal conservators who manage informed consent
- can not speak English
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 |
|---|---|---|
| Psychosocial Weight InterventionWeekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses | Behavioural | Psychosocial Weight Intervention |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Feasibility and acceptability of implementing preference assessment
Time frame: Baseline
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 6 Nov 2017.
- Background: PubMed 20658320Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
- Background: PubMed 23407006Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.
- Background: PubMed 18279505Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.
- Background: PubMed 15491237Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.
- Background: PubMed 20591993Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.
- 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.
Alexander S Young, MD, MSHS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Weight Intervention in people with Mental Disorders and Schizophrenia, run by University of California, Los Angeles 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 4 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 6 Nov 2017. 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?
Days until using weight services (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02183844, which also lists 5 linked publications.
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 6 Nov 2017.