Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
Primary Purpose
Arthritis, Psoriatic, Psoriasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immune Strength
Sponsored by
About this trial
This is an interventional other trial for Arthritis, Psoriatic focused on measuring Psoriatic Arthritis, Psoriasis, Mental Health, Well being
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 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
Sites / Locations
- The Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Assigned to Immune Strength program
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05571696
First Posted
July 26, 2022
Last Updated
November 29, 2022
Sponsor
Elaine Husni
Collaborators
National Psoriasis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05571696
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elaine Husni
Collaborators
National Psoriasis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic, Psoriasis
Keywords
Psoriatic Arthritis, Psoriasis, Mental Health, Well being
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Assigned to Immune Strength program
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Immune Strength
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.
Description
The PHQ-9 is used as a screening tool for assessment of the severity of depressive symptoms.
Time Frame
PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
PROMIS are a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults.
Time Frame
PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saima Goul, MS
Phone
216-444-4887
Email
gouls@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Husni, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saima Goul, MS
Phone
216-444-4887
Email
gouls@ccf.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
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