Overview

This trial is active, not recruiting.

Conditions mental illness, chronic medical illness
Treatments living well, health focused support and education
Sponsor VA Office of Research and Development
Start date October 2013
End date December 2016
Trial size 250 participants
Trial identifier NCT01676909, IIR 11-276

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose health services research
Arm
(Experimental)
Living Well will be implemented as a 12 session small-group intervention (4-8 persons). Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
living well
Living Well will be implemented as a 12 session small-group intervention (4-8 persons). Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
(Active Comparator)
The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
health focused support and education
The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.

Primary Outcomes

Measure
Short Form-12 (SF-12)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up

Secondary Outcomes

Measure
Illness Management Self-Efficacy
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Patient Activation Measure
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Measure of Self-Management Behaviors
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Morisky Medication Adherence Scale
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Colorado Symptom Index (CSI)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Service Utilization Data
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
The Mental Illness Research, Education and Clinical Center (MIRECC) Demographic Form
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Maryland Assessment of Recovery Scale (MARS)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS):
time frame: enrollment
Insomnia Severity Index (ISI)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Medical Conditions (MCON)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
PAIN Measure
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Participation with Services
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Substance Use and Health Behaviors (SUHB)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
Multidimensional Health Locus of Control (HLOC):
time frame: enrollment, randomization, post-treatment, 3 mo follow-up
General Medical and Psychiatric Services (GMED)
time frame: enrollment, randomization, post-treatment, 3 mo follow-up

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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"

Additional Information

Official title A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
Principal investigator Richard W Goldberg, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.