Smartphone CBT for Psoriasis and Depression

Overseen By Liset Chacin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Previous CBT, Psychotherapy, Suicide risk, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone-based program designed to help manage psoriasis and depression through cognitive behavioral therapy (CBT). The 8-week program, guided by a coach, aims to improve participants' mental and skin health. It suits individuals with dermatologist-confirmed psoriasis who are experiencing mild depression. Participants should be comfortable using a smartphone and not currently engaged in other therapy or have previously tried CBT for depression. As an unphased trial, this study provides a unique opportunity to explore innovative treatment methods and contribute to advancements in mental and skin health care.

Do I need to stop my current medications for the trial?

If you are taking psychotropic medications, you must have been on a stable dose for 2 months before joining the trial and stay on that stable dose during the 8-week study. The protocol does not specify requirements for other medications.

What prior data suggests that this smartphone-delivered CBT program is safe?

Research has shown that cognitive behavioral therapy (CBT) via smartphone is generally easy for people to manage. This non-invasive treatment does not involve surgery or medication. Studies have found that individuals often consider smartphone-based CBT practical and acceptable. No major safety concerns have arisen, as it primarily involves guided activities on a smartphone app. For those with both psoriasis and depression, this method could be a good fit, allowing users to participate from their own homes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for psoriasis and depression involve medications or traditional therapy sessions, which can be time-consuming and less accessible. However, the coach-guided smartphone-delivered CBT program is unique because it offers a flexible, mobile-based approach to cognitive behavioral therapy. This delivery method allows participants to receive support and therapy through their smartphones, making it more convenient and potentially more engaging. Researchers are excited about this treatment because it combines the effectiveness of CBT with the accessibility of digital technology, which could significantly enhance treatment adherence and outcomes for individuals with psoriasis and depression.

What evidence suggests that this smartphone-delivered CBT is effective for psoriasis and depression?

Research has shown that cognitive behavioral therapy (CBT) effectively reduces depression symptoms. People with psoriasis often experience depression, and CBT can improve their mental well-being. In this trial, all participants will enroll in a coach-guided CBT program accessible via smartphone. Previous users of smartphone-based CBT found it practical and acceptable. While specific evidence for psoriasis is still developing, the therapy's success in treating depression suggests it could also benefit those with both conditions. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with psoriasis who also have symptoms of depression. Participants should be comfortable using a smartphone and willing to engage in an 8-week CBT program guided by a coach, followed by a follow-up interview.

Inclusion Criteria

I am currently experiencing symptoms of depression.

Participants must be proficient in English and have access to an Android or iOS smartphone

A dermatologist has diagnosed me with psoriasis.

Exclusion Criteria

Any uncontrolled or poorly controlled chronic medical condition that may interfere with an individual's ability to participate in the clinical trial

Individuals who are incarcerated or compulsory detained

I've been on a stable dose of my mental health medication for 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in an 8-week coach-guided smartphone delivered CBT program

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up interview

1 week

1 follow-up interview (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Coach-guided smartphone delivered CBT program

Trial Overview The study is testing the effectiveness of an 8-week cognitive behavioral therapy (CBT) program delivered through a smartphone app, which includes guidance from a coach. All participants will receive this intervention.

How Is the Trial Designed?

Group I: Coach-guided smartphone delivered CBT program Experimental Treatment 1 Intervention

All eligible participants will be enrolled in an 8-week coach-guided smartphone delivered CBT program. The full duration of the program, with follow-up interview, will be 9 weeks.

Coach-guided smartphone delivered CBT program is already approved in United States for the following indications:

Approved in United States as Coach-guided smartphone delivered CBT program for:

• Psoriasis with co-morbid depression symptoms

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Psoriasis Foundation

Collaborator

Trials

12

Recruited

1,900+

Published Research Related to This Trial

A study involving 235 participants showed that the app-based intervention ImproveYourMood+ significantly reduced depressive symptoms and negative automatic thoughts over a 3-week period, with effects lasting up to one month after the intervention.

The most effective features of the app included mood monitoring, content delivery, and just-in-time prompts, indicating that comprehensive, multi-modal approaches may enhance user experience and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the features of an app-based just-in-time intervention for depression. Everitt, N., Broadbent, J., Richardson, B., et al.[2021]

A systematic review of mobile health apps for depression found that 74% of the evaluated apps had acceptable quality, with 32% scoring 4.0 or higher on the Mobile Application Rating Scale (MARS), indicating their potential effectiveness.

These high-quality apps can enhance patient self-management and treatment engagement, suggesting they may be valuable tools for individuals with depression who face barriers to traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. Myers, A., Chesebrough, L., Hu, R., et al.[2022]

A free smartphone app for depression screening was downloaded by 8,241 participants from 66 countries, demonstrating its global reach and feasibility as a self-help intervention.

The app identified a high prevalence of depression risk among users, with 82.5% scoring above the PHQ-9 cut-off of 11, indicating its potential effectiveness in screening and monitoring mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression screening via a smartphone app: cross-country user characteristics and feasibility. BinDhim, NF., Shaman, AM., Trevena, L., et al.[2022]

A systematic review of 12 studies found that smartphone applications for depression consistently led to a reduction in depressive symptoms, indicating their potential effectiveness as a self-management tool.

A survey of 72 healthcare professionals revealed a generally positive attitude towards using these apps in clinical practice, although many expressed a lack of knowledge and experience, suggesting that training and information could enhance their integration into treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications for depression: a systematic literature review and a survey of health care professionals' attitudes towards their use in clinical practice. Kerst, A., Zielasek, J., Gaebel, W.[2020]

A study involving 100 patients with rheumatoid arthritis and psoriasis revealed that 78% were willing to participate in internet-based cognitive behavioral therapy (CBT), indicating strong interest in this treatment option.

Patients highlighted the convenience and time-saving aspects of internet-based CBT as major advantages, but expressed concerns about computer illiteracy and the lack of personal interaction with therapists as significant drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What patients think about E-health: patients' perspective on internet-based cognitive behavioral treatment for patients with rheumatoid arthritis and psoriasis. Ferwerda, M., van Beugen, S., van Burik, A., et al.[2021]

The IMPROVE 1.0 smartphone app effectively allows psoriasis patients to self-monitor their disease severity and quality of life, showing strong correlations with physician assessments over a year-long study involving 12 participants.

Participants reported positive experiences with the app, indicating its potential to enhance self-awareness and integrate patients into their own disease management, which could lead to better outcomes and preventive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMPROVE 1.0: Individual Monitoring of Psoriasis Activity by Regular Online App Questionnaires and Outpatient Visits. Garzorz-Stark, N., Beicht, S., Baghin, V., et al.[2021]

Computer-delivered Cognitive Behavioral Therapies (C-CBT) are effective for treating depression, showing high effectiveness and adherence among self-referred individuals, based on a review of 22 randomized controlled studies.

Therapist support significantly enhances the effectiveness and adherence of C-CBT, particularly for outpatients referred by clinicians, highlighting the importance of integrating some level of guidance in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. Iakimova, G., Dimitrova, S., Burté, T.[2018]

A systematic review of seven studies on mobile health applications for depression found that while these apps are a promising new approach to mental health care, there is a critical need to focus on user acceptability and adherence rates to improve their effectiveness.

Most studies reviewed were conducted in developed countries, indicating a potential gap in understanding how these apps perform in diverse populations, and highlighting the need for innovative designs to enhance user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability, Acceptability, and Adherence Rates of Mobile Application Interventions for Prevention or Treatment of Depression: A Systematic Review. Rismawan, W., Marchira, CR., Rahmat, I.[2021]

Standalone smartphone-based ecological momentary interventions (EMIs) based on cognitive behavioral therapy (CBT) principles have been shown to significantly improve well-being and reduce mental health symptoms among users, according to a review of 26 studies.

Users rated these EMIs as helpful and satisfying, indicating their potential as scalable and accessible mental health support, especially important during global crises like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. Marciniak, MA., Shanahan, L., Rohde, J., et al.[2020]

In a study involving 131 patients with psoriasis, therapist-guided internet-based cognitive behavioral therapy (ICBT) significantly improved physical functioning and reduced the impact of psoriasis on daily activities compared to standard care, with effects lasting up to 6 months.

The quality of the therapeutic relationship established at the beginning of ICBT was found to predict better physical and psychological outcomes, highlighting its importance in personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored Therapist-Guided Internet-Based Cognitive Behavioral Treatment for Psoriasis: A Randomized Controlled Trial. van Beugen, S., Ferwerda, M., Spillekom-van Koulil, S., et al.[2022]

A pilot study with 35 participants suffering from Major Depression showed that both mobile app and computer-based delivery of a cognitive behavioral therapy program led to significant improvements in depression symptoms, as measured by the PHQ-9 scale.

The benefits of the therapy were maintained at a 3-month follow-up, indicating that mobile delivery of the CBT program is an effective option for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBT for depression: a pilot RCT comparing mobile phone vs. computer. Watts, S., Mackenzie, A., Thomas, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12507800/

A Trial of Coach-Supported, Smartphone-Delivered ... Psoriasis is associated with increased risk of depression. Although cognitive behavioral therapy (CBT) is an evidence-based treatment, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06216691

Smart Phone Delivered Cognitive Behavioral Therapy for ... A single arm, pilot study in which all eligible participants will be enrolled in an 8-week coach-guided smartphone delivered CBT program. The full duration of ...

3. psoriasis.org psoriasis.org/cbt-for-psoriasis-and-depression/

NPF-Funded Research: Smartphone Delivered Cognitive ... We aim to investigate if adults with psoriasis and depression symptoms find a smartphone-based CBT program to be acceptable and practical to ...

4. trialx.com trialx.com/clinical-trials/listings/267843/smart-phone-delivered-cognitive-behavioral-therapy-for-adults-with-psoriasis-and-co-morbid-depression-symptoms/

Smart Phone Delivered Cognitive Behavioral Therapy for ... A single arm, pilot study in which all eligible participants will be enrolled in an 8-week coach-guided smartphone delivered CBT program. The ...

5. withpower.com withpower.com/trial/phase-depressive-symptomatology-2024-290b3

Smartphone CBT for Psoriasis and Depression Trial Overview The study is testing the effectiveness of an 8-week cognitive behavioral therapy (CBT) program delivered through a smartphone app, which includes ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/453357

Smart Phone Delivered Cognitive Behavioral Therapy for ... A single arm, pilot study in which all eligible participants will be enrolled in an 8-week coach-guided smartphone delivered CBT program.