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

Sponsor

Elaine Husni (Other)

Overall Status

Recruiting

CT.gov ID

NCT05571696

Collaborator

National Psoriasis Foundation (Other)

120

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Psoriatic Psoriasis	Behavioral: Immune Strength	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 27, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Group Assigned to Immune Strength program	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.
Active Comparator: Control Group 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 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.

Arm

Intervention/Treatment

Active Comparator: Intervention Group

Assigned to Immune Strength program

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.

Active Comparator: Control Group

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 14
Computer and internet access
A valid email address
Able to speak & read English
Able to understand & sign informed consent

Exclusion Criteria:

PHQ9 score > 14
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