eCoaching Program for Mental Health in Psoriasis

Overseen By Sandra Hodnick, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elaine Husni

Disqualifiers: Major depressive disorder, Psychotherapy, Suicidal risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with psoriasis or psoriatic arthritis improve their mental health through an online eCoaching program called Immune Strength. The program enhances physical behaviors such as sleep, exercise, stress management, and nutrition, which are crucial for better mental well-being. Participants will either join the program immediately or wait 12 weeks as part of the control group. Ideal candidates are patients with psoriasis or psoriatic arthritis who have mild to moderate mental health concerns, are patients of Cleveland Clinic, have computer and internet access, and can read and understand English. As an unphased trial, this study offers participants the chance to potentially improve their mental health through innovative online support.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, as the trial focuses on an online eCoaching program to improve mental health.

What prior data suggests that the Immune Strength eCoaching Program is safe for mental health improvement in psoriatic disease patients?

Research has shown that online e-coaching programs like "Immune Strength" are generally safe. This program aids individuals with psoriasis in improving mental health by focusing on sleep, exercise, stress, and diet. With online coaching and access to a wellness expert, it involves no drugs or medical procedures, typically resulting in fewer risks.

Studies on similar e-coaching programs have found them to be well-received. Participants often report positive experiences with few negative effects, mostly related to adapting to digital tools. No evidence of serious side effects has been found with the "Immune Strength" program itself, suggesting it is a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for psoriasis, which typically involve topical creams, oral medications, or biologics targeting skin symptoms and immune responses, the Immune Strength program takes a different approach by focusing on mental health support. Researchers are excited about this trial because it explores the connection between mental well-being and psoriasis, aiming to enhance immune function through psychological coaching. This innovative angle could offer a more holistic treatment option, addressing both the physical and mental aspects of psoriasis, potentially leading to improved overall patient outcomes.

What evidence suggests that the Immune Strength eCoaching Program is effective for improving mental health in psoriasis?

Research shows that people with psoriatic diseases often experience mental health issues, such as increased anxiety and depression. Growing evidence indicates that improving habits like sleep, exercise, stress management, and nutrition can positively affect mental health. In this trial, participants in the Intervention Group will join the Immune Strength eCoaching program, which supports these lifestyle changes. Studies have found that eCoaching programs can effectively improve mental well-being in people with psoriasis. These programs help patients take charge of their health, potentially reducing the mental health challenges linked to psoriatic diseases. ^{3 6 7 8 9}

Who Is on the Research Team?

M. Elaine Husni, M.D., M.P.H.

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient of Cleveland Clinic

A doctor has diagnosed you with psoriasis or psoriatic arthritis.

Computer and internet access

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the 'Immune Strength' 12-week eCoaching program with weekly access to a wellness professional

12 weeks

Weekly virtual access to wellness professional

Follow-up

Participants are monitored for changes in mental health outcomes using PROMIS and PHQ-9 scores

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immune Strength

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Active Control 1 Intervention

Assigned to Immune Strength program

Group II: Control Group Active Control 1 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.

Who Is Running the Clinical Trial?

Elaine Husni

Lead Sponsor

Trials

2

Recruited

160+

National Psoriasis Foundation

Collaborator

Trials

12

Recruited

1,900+

Published Research Related to This Trial

More than half of psoriasis patients experience significant negative emotions, which can severely impact their quality of life, highlighting the psychological burden of the disease.

Inflammatory mediators, such as proinflammatory cytokines, play a crucial role in both psoriasis and associated mental health disorders like anxiety and depression, suggesting that addressing these inflammatory pathways could improve overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSYCHOPATHOLOGICAL DISORDERS AS COMORBIDITY IN PATIENTS WITH PSORIASIS (REVIEW). Bolotna, L., Sarian, O.[2022]

In a study of 200 psoriasis patients undergoing 12 weeks of narrowband ultraviolet B (NB-UVB) therapy, successful treatment significantly improved anxiety and depression levels, with reductions in the severity of skin lesions correlating with these mental health improvements.

The study found that a reduction in the area affected by psoriasis (measured by Body Surface Area, BSA) had a greater impact on alleviating anxiety and depression symptoms than just reducing the severity of the lesions, highlighting the importance of overall skin involvement in mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lesion area reduction and the amelioration of anxiety and depression states in psoriasis patients: A prospective clinical study. Yu, Y., Zhou, J., Huang, D., et al.[2023]

Psoriasis affects about 3% of adults in industrialized countries and is often linked to psychological stress and depression, which can worsen the condition.

Understanding the psychological impact on psoriasis patients can lead to better treatment strategies by promoting a multidisciplinary approach that addresses both skin and mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Stress and Depression in Psoriasis Patients - a Dermatologist's Perspective. Rigas, HM., Bucur, S., Ciurduc, DM., et al.[2020]

In a study of 19 individuals with chronic plaque psoriasis, increased night-time arousal was linked to poorer self-reported sleep quality, highlighting the psychological factors affecting sleep in these patients.

Interestingly, while sleep quality impacted next-day functioning (like fatigue and concentration), it did not correlate with the severity of psoriasis symptoms, suggesting that sleep disturbances may not directly influence the physical aspects of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between sleep disturbance, symptoms and daytime functioning in psoriasis: a prospective study integrating actigraphy and experience sampling methodology. Henry, AL., Chisholm, A., Carter, LA., et al.[2021]

Psoriasis is linked to serious mental health issues, including depression and suicidality, highlighting the need for integrated care that addresses both skin and mental health.

Targeting inflammatory pathways like TNF-alpha, IL-17, and IL-23 can reduce psoriasis activity, suggesting that managing inflammation may also help alleviate associated psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psoriasis and Mental Health Workshop Report: Exploring the Links between Psychosocial Factors, Psoriasis, Neuroinflammation and Cardiovascular Disease Risk. Kleyn, CE., Talbot, PS., Mehta, NN., et al.[2022]

A study of 185 adults with psoriasis and eczema revealed that these patients exhibit significant maladaptive schemas, such as emotional deprivation and social isolation, which are linked to higher levels of psychological distress.

Specific schemas like vulnerability to harm and defectiveness were found to predict anxiety, while social isolation and vulnerability to harm predicted depression, suggesting that addressing these cognitive patterns could improve psychological treatment for skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core beliefs and psychological distress in patients with psoriasis and atopic eczema attending secondary care: the role of schemas in chronic skin disease. Mizara, A., Papadopoulos, L., McBride, SR.[2015]

In a study of 60 psoriasis patients, higher levels of hope were positively correlated with better quality of life across various domains, including physical and psychological well-being.

The findings suggest that enhancing hope through psychotherapeutic interventions could significantly improve the quality of life for individuals with psoriasis, regardless of the severity or duration of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In psoriasis, levels of hope and quality of life are linked. Hawro, T., Maurer, M., Hawro, M., et al.[2022]

A study involving 1022 patients with moderate to severe psoriasis in Spain found that the disease significantly impacts health-related quality of life (HR-QOL), particularly affecting physical health scores in those with comorbidities like psoriatic arthritis, hypertension, and obesity.

Women with moderate to severe psoriasis who also have anxiety or depression experience even lower mental health scores, highlighting the psychological burden of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities and health-related quality of life in Spanish patients with moderate to severe psoriasis: a cross-sectional study (Arizona study). Sanchez-Carazo, JL., López-Estebaranz, JL., Guisado, C.[2015]

Psoriasis patients, especially those treated with PUVA, show a heightened cardiovascular response to psychological stress, indicated by increased heart rate and blood pressure, which may affect their overall health.

The study found that psoriasis patients had higher adrenaline levels but lower cortisol and DHEA levels compared to healthy controls, suggesting a unique stress response that could influence their immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress-induced endocrine and immunological changes in psoriasis patients and healthy controls. A preliminary study. Schmid-Ott, G., Jacobs, R., Jäger, B., et al.[2018]

In a study of 1,505 psoriasis patients, minor psychological distress (PD) was found in 46% of participants but decreased significantly over 12 months, indicating potential for improvement in mental health with time.

Major psychological distress remained stable at 11% over the same period, with coping strategies playing a crucial role in its evolution, highlighting the importance of support systems and coping mechanisms in managing PD in psoriasis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of and risk factors for psychological distress in patients with psoriasis: the PSYCHAE study. Colombo, D., Caputo, A., Finzi, A., et al.[2017]

The German Psoriasis Registry PsoBest, involving 2444 patients, found that both conventional systemic and biological treatments for moderate-to-severe psoriasis have similar safety profiles, with no significant differences in serious adverse events (SAE) such as infections, malignancies, and major cardiac events (MACE).

The overall rate of serious adverse events was low, at 1.3 per 100 patient years for conventional drugs and 1.5 for biologics, indicating that both treatment types are safe for long-term use in routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Reich, K., Mrowietz, U., Radtke, MA., et al.[2018]

A study of 245 psoriasis patients revealed that higher disease severity is linked to increased anxiety, depression, and social distress, highlighting the psychological impact of the condition.

Social support and coping strategies significantly influence mental health in psoriasis patients, with a strong correlation indicating that better social support and positive coping can help mitigate psychological issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the psychological health and related risk factors in 245 patients with psoriasis in Inner Mongolia. Zhang, Q., Han, J., Zhang, Y., et al.[2020]

Psoriasis, a chronic autoimmune skin disease affecting 2-4% of the global population, is linked to sleep disorders, which can worsen the quality of life and psychosocial status of patients.

The relationship between sleep disorders and psoriasis is bidirectional, creating a vicious cycle where each condition exacerbates the other, increasing the risk of metabolic and psychiatric diseases, highlighting the need for early screening and treatment of sleep issues in psoriatic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutual Relationship Between Sleep Disorders, Quality of Life and Psychosocial Aspects in Patients With Psoriasis. Nowowiejska, J., Baran, A., Flisiak, I.[2021]

In a clinical trial involving 26 participants (16 receiving XP-828L and 10 receiving placebo), a daily dose of 800 mg of XP-828L for 56 days significantly improved quality of life and reduced psoriasis severity compared to placebo, as measured by the Dermatology Life Quality Index (DLQI) and Psoriasis Area and Severity Index (PASI).

The study suggests that a lower daily dose of 800 mg of XP-828L may be more effective than the previously tested 5 g dose, indicating a potential for more efficient treatment of mild-to-moderate psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled, randomized trial of XP-828L (800 mg) on the quality of life and clinical symptoms of patients with mild-to-moderate psoriasis. Drouin, R., Moroni, O., Cantin, K., et al.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05571696

Study Details | NCT05571696 | Mind Matters: A High Touch ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8965012/

Assessing and Improving Psychological Well-Being in ... Psychosocial comorbidities strongly associated with psoriasis include anxiety and depression, suicidal ideation, and substance misuse.

3. my.clevelandclinic.org my.clevelandclinic.org/-/scassets/files/org/orthopaedics-rheumatology/publications/rhuematology-connections-summer-2023.pdf?la=en

Rheumatology Connections Immune. Strength uses self-directed patient empowerment to enhance mental wellness. One hundred participants with psoriatic diseases will be ...

4. researchgate.net researchgate.net/publication/391532668_Psychosocial_interventions_for_psoriasis_a_Bayesian_network_meta-analysis

(PDF) Psychosocial interventions for psoriasis: a Bayesian ... Conclusion We confirmed the effectiveness of psychosocial interventions on patients' well-being and mental health and recommended several interventions for ...

5. mednexus.org mednexus.org/doi/10.1097/JD9.0000000000000317

Mental Stress Affects the Occurrence and Development of ... Mental Stress Affects the Occurrence and Development of Psoriasis Through Neuroendocrine-Immune Regulation: A Narrative Review.

6. trials.arthritis.org trials.arthritis.org/trials/NCT05571696

A High Touch, Low Cost Approach to Improving Mental Health ... The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost ...

7. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05571696

Immune Strength in Psoriasis and Arthritis, Psoriatic - ICH GCP The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a ...

8. withpower.com withpower.com/clinical-trials/for-mental-health?page=2

Top Mental Health Clinical Trials | Power The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12052009/

Challenges Psoriasis and Its Impact on Quality of Life This comprehensive review examines the multidimensional impact of psoriasis on patients' lives, encompassing physical, psychological, and social aspects.