Arthritis, PsoriaticNCT05571696
Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
A study testing Immune Strength in people with Arthritis, Psoriatic and Psoriasis, run by Elaine Husni at 1 site in United States.
Trial summary
Despite advances in effective psoriatic disease treatment, the disease still has a serious impact on mental health and well-being of millions of patients. Up to 20.7% of patients report poor mental health, compared to 7.1% of the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic, Psoriasis
- What is being tested?
- Immune Strength
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2022to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient of Cleveland Clinic
- Adults (=18 years of age)
- Diagnosis of psoriasis or psoriatic arthritis by a board certified physician.
- PHQ9 score between 5 and 20
- Computer and internet access
- A valid email address
- Able to speak \& read English
- Able to understand \& sign informed consent
Who cannot join
- PHQ9 score > 20
- History of major depressive disorder
- Currently receiving psychotherapy for major depressive disorder (MDD), anxiety or psychotic disorder
- On a wait-list for psychotherapeutic treatment
- Received treatment for a severe psychiatric illness in the previous 6 months
- Demonstrate a notable suicidal risk at study visit
Trial locations and contacts
1 site in 1 country.
About this study
Despite advances in effective psoriatic disease treatment, the disease still has a serious impact on mental health and well-being of millions of patients. Up to 20.7% of patients report poor mental health, compared to 7.1% of the general population. Mental health treatment involves a combination of medication and talk therapy to address such issues. However, there is increasing evidence that optimizing behaviors such as sleep, physical activity, stress, and nutrition are critical components in improving mental health too. Numerous online health programs have evolved to help patients optimize such behaviors but very little exists for patients with psoriatic diseases. The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost, high-touch, personalized intervention that patients can access 24/7. In conjunction with traditional clinical care, the goal of this program is to leverage the convenience, affordability, scalability and effectiveness of an online eCoaching program to improve key physical behaviors, thereby reducing the mental health burden experienced by psoriatic disease patients.
- Conditions
- Arthritis, Psoriatic, Psoriasis
- Being tested
- Immune Strength
- Keywords
- Psoriatic Arthritis, Psoriasis, Mental Health, Well being
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune StrengthBehavioural
Immune Strength is a 12 week online program that provides content, strategies, and guidance on how to improve your immune system and increase your mental wellbeing, with a focus on stress, sleep, nutrition, and exercise. In addition to the online program, each participant will be paired with a Cleveland Clinic Coach who will communicate with the participant via email. The Coach will help guide the participant throughout the program and provide encouragement and guidance for making behavior changes for making a more resilient immune system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Assigned to Immune Strength program Receives: Behavioral: Immune Strength |
| Control Group | Active comparator | Assigned to 12 week waitlist, receiving usual care. Study participants assigned to the wait list will receive access to Immune Strength 12 weeks after study commencement. Receives: Behavioral: Immune Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.
The PHQ-9 is used as a screening tool for assessment of the severity of depressive symptoms.
Measured: PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.
Secondary outcomes (1)
Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS are a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults.
Measured: PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start27 Oct 2022
- Primary completion31 Mar 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaine Husni
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation
- Responsible party
- Sponsor-investigator, Elaine Husni, The Cleveland Clinic
- Investigators
- Elaine Husni, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571696
- Sponsor's protocol ID
- IRB#21-320
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2022
- Last updated
- 6 Oct 2025
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
- ClinicalTrials.gov ID
- NCT05571696
- Acronym / sponsor ID
- IRB#21-320
- Conditions
- Arthritis, Psoriatic, Psoriasis
- Keywords
- Psoriatic Arthritis, Psoriasis, Mental Health, Well being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Elaine HusniUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 7 Oct 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.
Despite advances in effective psoriatic disease treatment, the disease still has a serious impact on mental health and well-being of millions of patients. Up to 20.7% of patients report poor mental health, compared to 7.1% of the general population. Mental health treatment involves a combination of medication and talk therapy to address such issues. However, there is increasing evidence that optimizing behaviors such as sleep, physical activity, stress, and nutrition are critical components in improving mental health too. Numerous online health programs have evolved to help patients optimize such behaviors but very little exists for patients with psoriatic diseases. The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost, high-touch, personalized intervention that patients can access 24/7. In conjunction with traditional clinical care, the goal of this program is to leverage the convenience, affordability, scalability and effectiveness of an online eCoaching program to improve key physical behaviors, thereby reducing the mental health burden experienced by psoriatic disease patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: Immune StrengthAssigned to Immune Strength program |
| Control Group | Active comparator | Behavioral: Immune StrengthAssigned to 12 week waitlist, receiving usual care. Study participants assigned to the wait list will receive access to Immune Strength 12 weeks after study commencement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient of Cleveland Clinic
- Adults (=18 years of age)
- Diagnosis of psoriasis or psoriatic arthritis by a board certified physician.
- PHQ9 score between 5 and 20
- Computer and internet access
Key exclusion criteria (6 listed)
- PHQ9 score > 20
- History of major depressive disorder
- Currently receiving psychotherapy for major depressive disorder (MDD), anxiety or psychotic disorder
- On a wait-list for psychotherapeutic treatment
- Received treatment for a severe psychiatric illness in the previous 6 months
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 |
|---|---|---|
| Immune StrengthImmune Strength is a 12 week online program that provides content, strategies, and guidance on how to improve your immune system and increase your mental wellbeing, with a focus on stress, sleep, nutrition, and exercise. In addition to the online program, each participant will be paired with a Cleveland Clinic Coach who will communicate with the participant via email. The Coach will help guide the participant throughout the program and provide encouragement and guidance for making behavior changes for making a more resilient immune system. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.
Time frame: PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.
The PHQ-9 is used as a screening tool for assessment of the severity of depressive symptoms.
1 secondary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- 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.
Elaine Husni, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immune Strength in people with Arthritis, Psoriatic and Psoriasis, run by Elaine Husni 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 6 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion. (time frame: PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.). 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 6 Oct 2025.