eCoaching Program for Mental Health in Psoriasis

Recruiting in Palo Alto (17 mi)

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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Elaine Husni

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that eCoaching Program for Mental Health in Psoriasis is an effective treatment?

The available research shows that psychological resources like hope can improve the quality of life for people with psoriasis. Strengthening hope through psychotherapeutic interventions, like the eCoaching Program, could help improve mental health and quality of life. While the studies don't directly mention the eCoaching Program, they highlight the importance of mental health support in managing psoriasis. Compared to other treatments, focusing on mental health and hope could be a unique and effective approach. ^{1 2 3 4 5}

What safety data exists for the eCoaching Program for Mental Health in Psoriasis?

The provided research does not contain specific safety data for the eCoaching Program for Mental Health in Psoriasis or its alternative names like Immune Strength. The studies focus on other treatments and aspects of psoriasis, such as the safety of systemic drugs, psychological distress, and sleep disturbances in psoriasis patients. Therefore, no direct safety data for the eCoaching Program is available in the given research. ^{6 7 8 9 10}

Is the eCoaching Program for Mental Health in Psoriasis a promising treatment?

Yes, the eCoaching Program for Mental Health in Psoriasis is promising because it addresses the mental health challenges like anxiety and depression that often accompany psoriasis. By focusing on mental well-being, it can improve the overall quality of life for psoriasis patients. ^{4 11 12 13 14}

Research Team

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

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

Adults (=18 years of age)

A doctor has diagnosed you with psoriasis or psoriatic arthritis.

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.

Trial Timeline

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

Treatment Details

Interventions

• Immune Strength (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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 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]

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, 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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

In psoriasis, levels of hope and quality of life are linked. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Study on the psychological health and related risk factors in 245 patients with psoriasis in Inner Mongolia. [2020]

3. England 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). [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Lesion area reduction and the amelioration of anxiety and depression states in psoriasis patients: A prospective clinical study. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Mutual Relationship Between Sleep Disorders, Quality of Life and Psychosocial Aspects in Patients With Psoriasis. [2021]

6. United States 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. [2008]

7. England pubmed.ncbi.nlm.nih.gov

Evolution of and risk factors for psychological distress in patients with psoriasis: the PSYCHAE study. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. [2018]

9. Netherlands 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. [2021]

10. England 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. [2015]

11. Georgia (Republic) pubmed.ncbi.nlm.nih.gov

PSYCHOPATHOLOGICAL DISORDERS AS COMORBIDITY IN PATIENTS WITH PSORIASIS (REVIEW). [2022]

12. Romania pubmed.ncbi.nlm.nih.gov

Psychological Stress and Depression in Psoriasis Patients - a Dermatologist's Perspective. [2020]

13. Sweden pubmed.ncbi.nlm.nih.gov

Psoriasis and Mental Health Workshop Report: Exploring the Links between Psychosocial Factors, Psoriasis, Neuroinflammation and Cardiovascular Disease Risk. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Stress-induced endocrine and immunological changes in psoriasis patients and healthy controls. A preliminary study. [2018]