Wellness Self-Management
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/5/2016 |
| Start Date: | October 2013 |
| End Date: | November 2017 |
A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress
Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting
in increased risk of disability, high health care spending, reduced quality of life and
early mortality. Physical wellness is increasingly recognized as a key component of the VA's
commitment to developing recovery-oriented and Veteran-centered mental health treatment.
There is also growing recognition of the value of interventions that promote and improve
patient self-management of chronic medical conditions. Building on the established efficacy
of consumer facilitated medical illness self-management programming used in the general
population and two recent adaptations for use with SMI adults in the public health sector
(including the investigators' own evaluation of an intervention called Living Well), the
investigators propose to complete a randomized controlled effectiveness trial of the Living
Well intervention and simultaneously conduct a well specified process evaluation to optimize
knowledge accrual regarding important factors that may improve future adoption,
implementation and sustainability of the Living Well intervention in the VA system of care.
Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting
in increased risk of disability, high health care spending, reduced quality of life and
early mortality. Physical wellness is increasingly recognized as a key component of the VA's
commitment to developing recovery-oriented and Veteran-centered mental health treatment.
There is also growing recognition of the value of interventions that promote and improve
patient self-management of chronic medical conditions. Building on the established efficacy
of consumer facilitated medical illness self-management programming used in the general
population and two recent adaptations for use with SMI adults in the public health sector
(including the investigators' own evaluation of an intervention called Living Well), the
investigators propose to complete a randomized controlled effectiveness trial of the Living
Well intervention and simultaneously conduct a well specified process evaluation to optimize
knowledge accrual regarding important factors that may improve future adoption,
implementation and sustainability of the Living Well intervention in the VA system of care.
Background:
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress
Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting
in increased risk of disability, high health care spending, reduced quality of life and
early mortality. Physical wellness is increasingly recognized as a key component of the VA's
commitment to developing recovery-oriented and Veteran-centered mental health treatment.
There is also growing recognition of the value of interventions that promote and improve
patient self-management of chronic medical conditions. Building on the established efficacy
of consumer facilitated medical illness self-management programming used in the general
population and two recent adaptations for use with SMI adults in the public health sector
(including the investigators' own evaluation of an intervention called Living Well), the
investigators propose to complete a randomized controlled effectiveness trial of the Living
Well intervention and simultaneously conduct a well specified process evaluation to optimize
knowledge accrual regarding important factors that may improve future adoption,
implementation and sustainability of the Living Well intervention in the VA system of care.
Aims:
Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well
intervention with 234 Veterans with mental illness and at least one co-occurring chronic
medical condition and evaluate the intervention's effects on functional and service related
outcomes. The investigators hypothesize that those randomized to the Living Well
intervention will, in comparison to those randomized to a medical illness education and
support group, demonstrate improved general health functioning including physical and
emotional functioning as well as reduced rates of medical emergency room visits for
management of a chronic medical condition. The investigators will also evaluate intervention
effects on more proximal attitudinal and behavioral outcomes and assess how these factors
mediate improvement in the functional and services related outcomes.
Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation
framework to better understand contextual factors that can improve the Reach, Effectiveness,
Adoption, Implementation and Maintenance which together determine the potential public
health impact of the Living Well intervention.
Methods:
A mix of temporally overlapping quantitative and qualitative methods will be used to
maximize integration and synthesis of data streams across the two aims to optimize knowledge
accrual.
Impact:
Despite the growing recognition that self-management strategies hold enormous promise for
improving quality and outcomes of care for chronic medical illnesses, and the fact that
self-management is gaining prominence as a mental health recovery oriented treatment focus,
there are currently no evidence-based peer facilitated medical illness self-management
interventions available for dissemination within the VA mental health system. The proposed
study is designed to both generate evidence supporting the effectiveness of a peer
co-facilitated intervention and to help speed throughput to public health impact by
collecting important contextual information about factors that may improve future
dissemination and implementation efforts.
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress
Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting
in increased risk of disability, high health care spending, reduced quality of life and
early mortality. Physical wellness is increasingly recognized as a key component of the VA's
commitment to developing recovery-oriented and Veteran-centered mental health treatment.
There is also growing recognition of the value of interventions that promote and improve
patient self-management of chronic medical conditions. Building on the established efficacy
of consumer facilitated medical illness self-management programming used in the general
population and two recent adaptations for use with SMI adults in the public health sector
(including the investigators' own evaluation of an intervention called Living Well), the
investigators propose to complete a randomized controlled effectiveness trial of the Living
Well intervention and simultaneously conduct a well specified process evaluation to optimize
knowledge accrual regarding important factors that may improve future adoption,
implementation and sustainability of the Living Well intervention in the VA system of care.
Aims:
Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well
intervention with 234 Veterans with mental illness and at least one co-occurring chronic
medical condition and evaluate the intervention's effects on functional and service related
outcomes. The investigators hypothesize that those randomized to the Living Well
intervention will, in comparison to those randomized to a medical illness education and
support group, demonstrate improved general health functioning including physical and
emotional functioning as well as reduced rates of medical emergency room visits for
management of a chronic medical condition. The investigators will also evaluate intervention
effects on more proximal attitudinal and behavioral outcomes and assess how these factors
mediate improvement in the functional and services related outcomes.
Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation
framework to better understand contextual factors that can improve the Reach, Effectiveness,
Adoption, Implementation and Maintenance which together determine the potential public
health impact of the Living Well intervention.
Methods:
A mix of temporally overlapping quantitative and qualitative methods will be used to
maximize integration and synthesis of data streams across the two aims to optimize knowledge
accrual.
Impact:
Despite the growing recognition that self-management strategies hold enormous promise for
improving quality and outcomes of care for chronic medical illnesses, and the fact that
self-management is gaining prominence as a mental health recovery oriented treatment focus,
there are currently no evidence-based peer facilitated medical illness self-management
interventions available for dissemination within the VA mental health system. The proposed
study is designed to both generate evidence supporting the effectiveness of a peer
co-facilitated intervention and to help speed throughput to public health impact by
collecting important contextual information about factors that may improve future
dissemination and implementation efforts.
Inclusion Criteria:
- a diagnosis of schizophrenia/ schizoaffective disorder
- bipolar disorder
- major depression with psychotic features
- post traumatic stress disorder
- or psychosis not otherwise specified (NOS)
- age between 18 and 80
- chart documented presence of at least one of the following chronic medical
conditions:
- a respiratory condition (e.g. asthma, COPD)
- diabetes
- arthritis
- cardiovascular condition (e.g. congestive heart failure, hypertension, etc.)
- receiving mental health services at a designated study site
- willing and able to provide consent to participate
- deemed clinically stable enough to participate in the study by a treatment provider
Exclusion Criteria:
- Severe or profound mental retardation
- Because participants must be able to attend the intervention if assigned to either
condition, we will also require potential participants to verify their availability
during screening
- Participation in current ongoing study 'Reducing Internalized Stigma in People with
Serious Mental Illness"
We found this trial at
2
sites
Baltimore, Maryland 21201
Principal Investigator: Richard W Goldberg, PhD
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