Enhancing Immune Health Randomized Controlled Trial

NCT05639881 | Active Not Recruiting

• 1 other identifier: STUDY2022-1075
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  study entry (pre-intervention), immediate post-intervention, 3 months post-intervention

Secondary Outcomes (3)

• Change in Perceived Competence for Health Management

  study entry (pre-intervention), immediate post-intervention, 3 months post-intervention

• Change in Coping Mastery

  study entry (pre-intervention), immediate post-intervention, 3 months post-intervention

• Change in Health Promoting Lifestyle

  study entry (pre-intervention), immediate post-intervention, 3 months post-intervention

Study Arms (2)

Experimental: Intervention

EXPERIMENTAL

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

Behavioral: Enhancing Your Immune Health

Services as Usual

ACTIVE COMPARATOR

Subjects receive routine mental health care.

Behavioral: Enhancing Your Immune Health

Interventions

Enhancing Your Immune Health BEHAVIORAL

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

Experimental: Intervention; Services as Usual

Eligibility Criteria

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

You may qualify if:

• Age 18 and older
• Serious mental illness
• Membership in a collaborating community mental health agency
• Access to the Internet
• Able to provide informed consent

You may not qualify if:

• Cognitive impairment preventing informed consent
• Unable to communicate in English

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research interviewers are blinded to study condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 6, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)