Wellness Self-Management

NCT01676909 | Completed Results

• 1 other identifier: IIR 11-276
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mental Illness; Chronic Medical Illness

Keywords

self-management

Outcome Measures

Primary Outcomes (4)

• Short Form-12 (SF-12) General Health (Norm Based)

  12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

  Baseline, Post-intervention (3 months after baseline)

• Short-Form 12 (SF-12) Physical Scale (Norm Based)

  12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

  Baseline, Post-intervention (3 months after baseline)

• Short-Form 12 (SF-12) Mental Scale (Norm Based)

  12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

  Baseline, Post-intervention (3 months after baseline)

• ER Visit Between Baseline and the 6-month Follow-up

  Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.

  Baseline, Follow-up (6-months after baseline)

Secondary Outcomes (19)

• Illness Management Self-Efficacy

  Baseline, Post-intervention (3 months after baseline)

• Patient Activation Measure

  Baseline, Post-intervention (3 months after baseline)

• Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale

  Baseline, Post-intervention (3 months after baseline)

• Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale

  Baseline, Post-intervention (3 months after baseline)

• Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale

  Baseline, Post-intervention (3 months after baseline)

Other Outcomes (6)

• Morisky Medication Adherence Scale

  Baseline, Post-intervention (3 months after baseline)

• Multidimensional Health Locus of Control (HLOC)

  Baseline, Post-intervention (3 months after baseline)

• Maryland Assessment of Recovery Scale (MARS)

  Baseline, Post-intervention (3 months after baseline)

Study Arms (2)

Living Well

EXPERIMENTAL

This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. After completing the 12 weekly groups, participants will return to complete once monthly booster group sessions for the next three months.

Behavioral: Living Well

Medical Illness Education & Support Group

ACTIVE COMPARATOR

We selected a comparison condition that would provide parallel focus (i.e. medical illness) but not include use of the core ingredients undergirding the Living Well intervention including behavioral action planning, problem solving, in-session and between session practice using specific disease self-management techniques and involvement of peer co-facilitators to enhance modeling and improve self-efficacy and activation. As with Living Well, the content of the intervention will have broad applicability across diverse chronic disease conditions. The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition.

Behavioral: Medical Illness Education & Support Group

Interventions

Living Well BEHAVIORAL

This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.

Living Well

Medical Illness Education & Support Group BEHAVIORAL

The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.

Medical Illness Education & Support Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Muralidharan A, Peeples A, Lucksted A. Health Behavior Change Processes Among Adults With Serious Mental Illness Engaged in Illness Self-Management. Qual Health Res. 2021 May;31(6):1155-1168. doi: 10.1177/1049732321992049. Epub 2021 Feb 15.

  PMID: 33588639 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Self-Help Groups

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Mary Brighid Walsh
• Organization: Department of Veterans Affairs, VAMHCS MIRECC

marybrighid.walsh@va.gov

410-637-1860

Study Officials

• Richard W Goldberg, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: August 31, 2012
• Study Start: October 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)