Mental DisorderNCT05639881
Enhancing Immune Health Randomized Controlled Trial
A study testing Enhancing Your Immune Health in people with Mental Disorder, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Enhancing Your Immune Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Serious mental illness
- Membership in a collaborating community mental health agency
- Access to the Internet
- Able to provide informed consent
Who cannot join
- Cognitive impairment preventing informed consent
- Unable to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities
This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- Enhancing Your Immune Health
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing Your Immune HealthBehavioural
In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention | Experimental | Subjects receive a brief intervention to improve their immune health literacy and self-management skills. Receives: Behavioral: Enhancing Your Immune Health |
| Services as Usual | Active comparator | Subjects receive routine mental health care. Receives: Behavioral: Enhancing Your Immune Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 May 2023
- Primary completionOct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Judith A. Cook, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639881
- Sponsor's protocol ID
- STUDY2022-1075
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT05639881
- Acronym / sponsor ID
- STUDY2022-1075
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention | Experimental | Behavioral: Enhancing Your Immune HealthSubjects receive a brief intervention to improve their immune health literacy and self-management skills. |
| Services as Usual | Active comparator | Behavioral: Enhancing Your Immune HealthSubjects receive routine mental health care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and older
- Serious mental illness
- Membership in a collaborating community mental health agency
- Access to the Internet
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Cognitive impairment preventing informed consent
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhancing Your Immune HealthIn addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors. | Behavioural | Experimental: Intervention, Services as Usual |
Primary outcome
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.
3 secondary outcomes
Change in Perceived Competence for Health Management
Time frame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Change in Coping Mastery
Time frame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Change in Health Promoting Lifestyle
Time frame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing Your Immune Health in people with Mental Disorder, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Immune Status (time frame: study entry (pre-intervention), immediate post-intervention, 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.