We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Immune Health Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639881
Recruitment Status : Not yet recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Judith A. Cook, 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.

Condition or disease Intervention/treatment Phase
Mental Disorder Behavioral: Enhancing Your Immune Health Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Research interviewers are blinded to study condition.
Primary Purpose: Supportive Care
Official Title: Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities
Estimated Study Start Date : February 28, 2023
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : February 28, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Intervention
Subjects receive a brief intervention to improve their immune health literacy and self-management skills.
Behavioral: 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.

Active Comparator: Services as Usual
Subjects receive routine mental health care.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Immune Status [ Time Frame: 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 :
  1. Change in Perceived Competence for Health Management [ Time Frame: 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.

  2. Change in Coping Mastery [ Time Frame: 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.

  3. Change in Health Promoting Lifestyle [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639881


Contacts
Layout table for location contacts
Contact: Judith A Cook, Ph.D. 312-355-3921 jcook@uic.edu

Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Disability, Independent Living, and Rehabilitation Research
Layout table for additonal information
Responsible Party: Judith A. Cook, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT05639881    
Other Study ID Numbers: STUDY2022-1075
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders