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OpenTrials
Completed

NCT Number: NCT05571696

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elaine Husni

Other

Collaborators

  • National Psoriasis Foundation

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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