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

NCT05571696 | Completed

• 1 other identifier: IRB#21-320
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Psoriatic Arthritis; Psoriasis; Mental Health; Well being

Outcome Measures

Primary Outcomes (1)

• 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.

  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 measure scores will be collected at the start of the intervention and immediately after the intervention is complete.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Assigned to Immune Strength program

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.

Behavioral: Immune Strength

Interventions

Immune Strength 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; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elaine Husni: lead
• National Psoriasis Foundation: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis; Psychological Well-Being

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Personal Satisfaction; Behavior

Study Officials

• Elaine Husni, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Rheumatologist

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: October 7, 2022
• Study Start: October 27, 2022
• Primary Completion: March 31, 2025
• Study Completion: April 14, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)