Enhancing Immune Health Randomized Controlled Trial

University of Illinois

Status: Enrolling

Conditions: Mental Disorder

Treatments: Behavioral: Enhancing Your Immune Health

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05639881

STUDY2022-1075

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental: Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Enhancing Your Immune Health

Services as Usual

Active Comparator group

Description:

Subjects receive routine mental health care.

Treatment:

Behavioral: Enhancing Your Immune Health