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Enhancing Immune Health Randomized Controlled Trial

NCT ID: NCT05639881

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Research interviewers are blinded to study condition.

Study Groups

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Experimental: Intervention

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

Group Type EXPERIMENTAL

Enhancing Your Immune Health

Intervention Type BEHAVIORAL

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

Services as Usual

Subjects receive routine mental health care.

Group Type ACTIVE_COMPARATOR

Enhancing Your Immune Health

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Judith A. Cook

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Illinois Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Judith A Cook, Ph.D.

Role: CONTACT

Phone: 312-355-3921

Email: [email protected]

Facility Contacts

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Judith A Cook

Role: primary

Other Identifiers

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STUDY2022-1075

Identifier Type: -

Identifier Source: org_study_id