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Enhancing Immune Health Randomized Controlled Trial

Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05639881
Enrollment
100
Registered
2022-12-06
Start date
2023-05-01
Completion date
2026-12-31
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorder

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.

Interventions

BEHAVIORALEnhancing Your Immune Health

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Research interviewers are blinded to study condition.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Immune Statusstudy entry (pre-intervention), immediate post-intervention, 3 months post-interventionThe 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

MeasureTime frameDescription
Change in Perceived Competence for Health Managementstudy entry (pre-intervention), immediate post-intervention, 3 months post-interventionThe 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 Masterystudy entry (pre-intervention), immediate post-intervention, 3 months post-interventionChange 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 Lifestylestudy entry (pre-intervention), immediate post-intervention, 3 months post-interventionThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026