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

Not Applicable

Recruiting

• Conditions: Arthritis, Psoriatic; Psoriasis

• Registration Number: NCT05571696
• Lead Sponsor: Elaine Husni

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-07
• Study Start: 2022-10-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-03
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States