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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05639881
Other study ID # STUDY2022-1075
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date February 28, 2026

Study information

Verified date November 2023
Source University of Illinois at Chicago
Contact Judith A Cook, Ph.D.
Phone 312-355-3921
Email jcook@uic.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 28, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Illinois Chicago Chicago Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Secondary 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. study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Secondary 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. study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
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