Enhancing Immune Health Randomized Controlled Trial
- Conditions
- Mental Disorder
- Interventions
- Behavioral: Enhancing Your Immune Health
- Registration Number
- NCT05639881
- Lead Sponsor
- University of Illinois at Chicago
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age 18 and older
- Serious mental illness
- Membership in a collaborating community mental health agency
- Access to the Internet
- Able to provide informed consent
- Cognitive impairment preventing informed consent
- Unable to communicate in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Intervention Enhancing Your Immune Health Subjects receive a brief intervention to improve their immune health literacy and self-management skills. Services as Usual Enhancing Your Immune Health Subjects receive routine mental health care.
- Primary Outcome Measures
Name Time Method Change in Immune Status study entry (pre-intervention), immediate post-intervention, 3 months post-intervention 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.
- Secondary Outcome Measures
Name Time Method Change in Health Promoting Lifestyle study entry (pre-intervention), immediate post-intervention, 3 months post-intervention 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.
Change in Perceived Competence for Health Management study entry (pre-intervention), immediate post-intervention, 3 months post-intervention 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.
Change in Coping Mastery study entry (pre-intervention), immediate post-intervention, 3 months post-intervention 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.
Trial Locations
- Locations (1)
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States