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Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases

Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05571696
Enrollment
84
Registered
2022-10-07
Start date
2022-10-27
Completion date
2025-04-14
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic, Psoriasis

Keywords

Psoriatic Arthritis, Psoriasis, Mental Health, Well being

Brief 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. 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.

Interventions

BEHAVIORALImmune Strength

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.

Sponsors

National Psoriasis Foundation
CollaboratorOTHER
Elaine Husni
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.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.

Secondary

MeasureTime frameDescription
Patient-Reported Outcomes Measurement Information System (PROMIS)PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.PROMIS are a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026