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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571696
• Other study ID #: IRB#21-320
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Saima Goul, MS
• Phone: 216-444-4887
• Email: gouls[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Elaine Husni	National Psoriasis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.