Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05639881

Enhancing Immune Health Randomized Controlled Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mental Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Immune Status

    Time frame: 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 outcomes

  1. Change in Perceived Competence for Health Management

    Time frame: 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.

  2. Change in Coping Mastery

    Time frame: 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.

  3. Change in Health Promoting Lifestyle

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.