Enhancing Immune Health Randomized Controlled Trial
Primary Purpose
Mental Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhancing Your Immune Health
Sponsored by

About this trial
This is an interventional supportive care trial for Mental Disorder
Eligibility Criteria
Inclusion Criteria: Age 18 and older Serious mental illness Membership in a collaborating community mental health agency Access to the Internet Able to provide informed consent Exclusion Criteria: Cognitive impairment preventing informed consent Unable to communicate in English
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: Intervention
Services as Usual
Arm Description
Subjects receive a brief intervention to improve their immune health literacy and self-management skills.
Subjects receive routine mental health care.
Outcomes
Primary Outcome Measures
Change in Immune Status
The Immune Status Questionnaire (ISQ) measures self-reported immune status. The questionnaire consists of 7 items measuring indicators of immune health including headache, muscle and joint pain, cough, and sudden high fever. Respondents rate each item using a 5-point Likert scale ranging from "never" to "always or almost always." Responses are coded 0-4 and summed for a total score potentially ranging from 0 to 28 with higher scores indicating a poorer immune status.
Secondary Outcome Measures
Change in Perceived Competence for Health Management
The Perceived Competence for Health Management scale measures participants' feelings of competence about their ability to manage their immune health. This 4-item scale uses a 7-point Likert response format ranging from "not at all true" to "very true." The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Change in Coping Mastery
Change in subjects' sense of personal control over important life outcomes is assessed via 7 items of the Coping Mastery Scale rated along a 4-point Likert scale from "strongly disagree" to "strongly agree." Higher values equal better coping mastery. Minimum=2 and maximum=49.
Change in Health Promoting Lifestyle
The ability to engage in health promoting behaviors and practices is assessed via self-report on a 26-item Health Promoting Lifestyle Profile II scale that yields a total score and 3 subscales measuring nutrition, physical activity, and emotional and spiritual wellness.
Full Information
NCT ID
NCT05639881
First Posted
November 1, 2022
Last Updated
May 8, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
1. Study Identification
Unique Protocol Identification Number
NCT05639881
Brief Title
Enhancing Immune Health Randomized Controlled Trial
Official Title
Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.
Detailed Description
This study is testing the efficacy of a brief intervention designed to improve immune health literacy and behaviors among adults with mental illnesses. This psychoeducational intervention supports lifestyle changes, including promotion of immunity-enhancing nutrition and immunity aids, activated intentions to receive needed inoculations and annual health screenings, better sleep, and more effective stress management. Adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. They are assessed at baseline, two months post-baseline, and three months later. Multivariable analysis models are used to assess the primary outcome of self-reported immune status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention improves health literacy and self-management skills using a framework comprised of the psychoeducational strategies of explanation, evaluation, and engagement. Over the course of 5 structured sessions, instructors impart immune health information using visual aids. They evaluate what participants already know about immune health to assess how to expand participants' understanding of immunity and health self-management. Instructors engage participants in personally-meaningful activities and goals to improve their immune health literacy and behaviors. For 3 months after class ends, monthly booster sessions are held.
Masking
Outcomes Assessor
Masking Description
Research interviewers are blinded to study condition.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Intervention
Arm Type
Experimental
Arm Description
Subjects receive a brief intervention to improve their immune health literacy and self-management skills.
Arm Title
Services as Usual
Arm Type
Active Comparator
Arm Description
Subjects receive routine mental health care.
Intervention Type
Behavioral
Intervention Name(s)
Enhancing Your Immune Health
Intervention Description
In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.
Primary Outcome Measure Information:
Title
Change in Immune Status
Description
The Immune Status Questionnaire (ISQ) measures self-reported immune status. The questionnaire consists of 7 items measuring indicators of immune health including headache, muscle and joint pain, cough, and sudden high fever. Respondents rate each item using a 5-point Likert scale ranging from "never" to "always or almost always." Responses are coded 0-4 and summed for a total score potentially ranging from 0 to 28 with higher scores indicating a poorer immune status.
Time Frame
study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Secondary Outcome Measure Information:
Title
Change in Perceived Competence for Health Management
Description
The Perceived Competence for Health Management scale measures participants' feelings of competence about their ability to manage their immune health. This 4-item scale uses a 7-point Likert response format ranging from "not at all true" to "very true." The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Time Frame
study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Title
Change in Coping Mastery
Description
Change in subjects' sense of personal control over important life outcomes is assessed via 7 items of the Coping Mastery Scale rated along a 4-point Likert scale from "strongly disagree" to "strongly agree." Higher values equal better coping mastery. Minimum=2 and maximum=49.
Time Frame
study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Title
Change in Health Promoting Lifestyle
Description
The ability to engage in health promoting behaviors and practices is assessed via self-report on a 26-item Health Promoting Lifestyle Profile II scale that yields a total score and 3 subscales measuring nutrition, physical activity, and emotional and spiritual wellness.
Time Frame
study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and older
Serious mental illness
Membership in a collaborating community mental health agency
Access to the Internet
Able to provide informed consent
Exclusion Criteria:
Cognitive impairment preventing informed consent
Unable to communicate in English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith A Cook, Ph.D.
Phone
312-355-3921
Email
jcook@uic.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhancing Immune Health Randomized Controlled Trial
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