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

September 30, 2025 updated by: Elaine Husni
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sandra Hodnick, MS
  • Phone Number: 216-444-6039
  • Email: hodnics@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elaine Husni

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Psoriasis Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elaine Husni, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#21-320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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