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

NCT ID: NCT05571696

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2025-04-14

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.

Conditions

Arthritis, Psoriatic; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Assigned to Immune Strength program

Group Type: ACTIVE_COMPARATOR

Immune Strength

Intervention Type: BEHAVIORAL

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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Immune Strength

Intervention Type: BEHAVIORAL

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.

Interventions

Immune 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Psoriasis Foundation

OTHER

Sponsor Role: collaborator

Elaine Husni

OTHER

Sponsor Role: lead

Responsible Party

Elaine Husni

Staff Rheumatologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elaine Husni, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB#21-320

Identifier Type: -

Identifier Source: org_study_id