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eCoaching Program for Mental Health in Psoriasis
N/A
Recruiting
Led By Elaine Husni, MD
Research Sponsored by Elaine Husni
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phq-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to reduce mental health burden of psoriatic disease patients with an online eCoaching program to improve physical behaviors.
Who is the study for?
This trial is for adult patients at the Cleveland Clinic with psoriasis or psoriatic arthritis, who have mild to moderate depression but not severe psychiatric conditions. Participants need computer access, an email address, and must understand English.
What is being tested?
The 'Immune Strength' program combines online coaching with traditional care to improve mental health in psoriatic disease patients. It's a 12-week course offering weekly contact with wellness professionals through eCoaching.
What are the potential side effects?
Since this intervention focuses on lifestyle changes and does not involve medication, typical drug side effects are not expected. However, participants may experience stress or discomfort when adjusting to new routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ promis measure scores will be collected at the start of the intervention and immediately after the intervention is complete.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~promis measure scores will be collected at the start of the intervention and immediately after the intervention is complete.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.
Secondary study objectives
Patient-Reported Outcomes Measurement Information System (PROMIS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Intervention GroupActive Control1 Intervention
Assigned to Immune Strength program
Group II: Control GroupActive Control1 Intervention
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.
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Who is running the clinical trial?
Elaine HusniLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
National Psoriasis FoundationOTHER
11 Previous Clinical Trials
1,762 Total Patients Enrolled
10 Trials studying Psoriasis
1,740 Patients Enrolled for Psoriasis
Elaine Husni, MDPrincipal InvestigatorThe Cleveland Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- A doctor has diagnosed you with psoriasis or psoriatic arthritis.You have a score between 5 to 14 on a depression questionnaire called PHQ9.You have a high risk of trying to harm yourself or commit suicide during the study.You are currently on a waiting list to receive psychotherapy treatment.You have been diagnosed with a serious form of depression in the past.You have received treatment for a serious mental health condition within the last 6 months.You have a score greater than 14 on the PHQ9 questionnaire, which measures symptoms of depression.You are currently receiving counseling for a mental health condition such as depression, anxiety, or psychosis.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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