Clinical trial NCT05639881: Enhancing Immune Health Randomized Controlled Trial
Official title: Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2022-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Immune Status
timeFrame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Secondary outcomes:
measure: Change in Perceived Competence for Health Management
timeFrame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
measure: Change in Coping Mastery
timeFrame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
measure: Change in Health Promoting Lifestyle
timeFrame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References: