Enhancing Immune Health Randomized Controlled Trial

Study Overview
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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.

Official Title
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Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities

Conditions
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Mental Disorder

Intervention / Treatment
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* Behavioral: Enhancing Your Immune Health


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Intervention<br>Subjects receive a brief intervention to improve their immune health literacy and self-management skills. | Behavioral: Enhancing Your Immune Health<br>* In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.<br>|
| Active Comparator: Services as Usual<br>Subjects receive routine mental health care. | Behavioral: Enhancing Your Immune Health<br>* In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Immune Status | 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. | study entry (pre-intervention), immediate post-intervention, 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Competence for Health Management | 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. | study entry (pre-intervention), immediate post-intervention, 3 months post-intervention | 
| Change in Coping Mastery | 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. | study entry (pre-intervention), immediate post-intervention, 3 months post-intervention | 
| Change in Health Promoting Lifestyle | 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. | study entry (pre-intervention), immediate post-intervention, 3 months post-intervention |