N/A N=242 Randomized Single-blind Health Services Research

Wellness Self-Management

Mental Illness · Chronic Medical Illness

Bottom Line

View on ClinicalTrials.gov: NCT01676909 ↗

Enrolled (actual)

242

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Short Form-12 (SF-12) General Health (Norm Based) — 40.4; 38.9; 42.5; 41.6 units on a scale — p=0.362

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Living Well (Behavioral); Medical Illness Education & Support Group (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Short Form-12 (SF-12) General Health (Norm Based)	40.4; 38.9; 42.5; 41.6; 42.9; 39.2	0.142
PRIMARY Short-Form 12 (SF-12) Physical Scale (Norm Based)	39.2; 38.6; 39.0; 40.2; 40.3; 38.4	0.342
PRIMARY Short-Form 12 (SF-12) Mental Scale (Norm Based)	41.3; 40.7; 44.0; 40.5; 42.7; 41.5	0.563
PRIMARY ER Visit Between Baseline and the 6-month Follow-up	49; 45; 47; 48	.64
SECONDARY Illness Management Self-Efficacy	5.5; 5.5; 6.2; 5.4; 6.0; 5.4	0.004 sig
SECONDARY Patient Activation Measure	60.8; 58.8; 64.3; 58.9; 63.4; 60.5	0.727
SECONDARY Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale	2.7; 2.3; 2.9; 2.6; 2.9; 2.5	0.446
SECONDARY Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale	2.9; 2.5; 3.3; 2.9; 3.3; 3.0	0.459
SECONDARY Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale	2.2; 2.2; 2.5; 2.2; 2.5; 2.3	0.038 sig
SECONDARY Measure of Self-Management Behaviors - Accessing Social Support Subscale	2.3; 2.3; 2.4; 2.4; 2.2; 2.3	0.238
SECONDARY Measure of Self-Management Behaviors - Physical Activity Subscale	2.3; 2.3; 2.7; 2.4; 2.8; 2.2	0.011 sig
SECONDARY Measure of Self-Management Behaviors - Healthy Eating Subscale	2.6; 2.5; 3.0; 2.7; 2.9; 2.8	0.709
SECONDARY Short Form-12 (SF-12) General Health (Norm Based)	40.4; 38.9; 42.5; 41.6; 42.9; 39.2	0.142
SECONDARY Short-Form 12 (SF-12) Physical Scale (Norm Based)	39.2; 38.6; 39.0; 40.2; 40.3; 38.4	0.342
SECONDARY Short-Form 12 (SF-12) Mental Scale (Norm Based)	41.3; 40.7; 44.0; 40.5; 42.7; 41.5	0.563
SECONDARY Illness Management Self-Efficacy	5.5; 5.5; 6.2; 5.4; 6.0; 5.4	0.004 sig
SECONDARY Patient Activation Measure	60.8; 58.8; 64.3; 58.9; 63.4; 60.5	0.727
SECONDARY Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale	2.7; 2.3; 2.9; 2.6; 2.9; 2.5	0.446
SECONDARY Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale	2.9; 2.5; 3.3; 2.9; 3.3; 3.0	0.459
SECONDARY Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale	2.2; 2.2; 2.5; 2.2; 2.5; 2.3	0.038 sig
SECONDARY Measure of Self-Management Behaviors - Accessing Social Support Subscale	2.3; 2.3; 2.4; 2.4; 2.2; 2.3	0.238
SECONDARY Measure of Self-Management Behaviors - Physical Activity Subscale	2.3; 2.3; 2.7; 2.4; 2.8; 2.2	0.011 sig
SECONDARY Measure of Self-Management Behaviors - Healthy Eating Subscale	2.6; 2.5; 3.0; 2.7; 2.9; 2.8	0.709

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.

Eligibility Criteria

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"

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Data sourced from ClinicalTrials.gov (NCT01676909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.