Enhancing Immune Health Randomized Controlled Trial

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05639881

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorder	Behavioral: Enhancing Your Immune Health	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Outcomes Assessor)

Masking Description:

Research interviewers are blinded to study condition.

Primary Purpose:

Supportive Care

Official Title:

Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Feb 28, 2026

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Intervention Subjects receive a brief intervention to improve their immune health literacy and self-management skills.	Behavioral: Enhancing Your Immune Health In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.
Active Comparator: Services as Usual Subjects receive routine mental health care.	Behavioral: Enhancing Your Immune Health In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.

Arm

Intervention/Treatment

Experimental: Experimental: Intervention

Subjects receive a brief intervention to improve their immune health literacy and self-management skills.

Behavioral: Enhancing Your Immune Health

In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.

Active Comparator: Services as Usual

Subjects receive routine mental health care.

Behavioral: Enhancing Your Immune Health

In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.

Outcome Measures

Primary Outcome Measures

Change in Immune Status [study entry (pre-intervention), immediate post-intervention, 3 months post-intervention]
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 [study entry (pre-intervention), immediate post-intervention, 3 months post-intervention]
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 [study entry (pre-intervention), immediate post-intervention, 3 months post-intervention]
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 [study entry (pre-intervention), immediate post-intervention, 3 months post-intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Illinois at Chicago
National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Judith A. Cook, Professor, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT05639881

Other Study ID Numbers:

STUDY2022-1075

First Posted:

Dec 6, 2022

Last Update Posted:

Dec 6, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mental Disorders

Study Results

No Results Posted as of Dec 6, 2022