Clinical trial NCT05571696: Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
Official title: Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis, Psoriatic
Psoriasis
Keywords: Psoriatic Arthritis
Psoriasis
Mental Health
Well being
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2022-10-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.
timeFrame: PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Elaine Husni, MD
role: PRINCIPAL_INVESTIGATOR
References: