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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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 the program, with follow-up interview, will be 9 weeks.

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 data supports the effectiveness of the treatment Coach-guided smartphone delivered CBT program for Psoriasis and Depression?

Research shows that smartphone apps based on cognitive behavioral therapy (CBT) can effectively reduce symptoms of depression. These apps are considered promising tools for managing mental health, as they provide scalable and accessible interventions. ^{1 2 3 4 5}

Is smartphone-delivered CBT safe for humans?

Research on smartphone-delivered cognitive behavioral therapy (CBT) shows it is generally safe for humans, with many patients finding it beneficial and easy to use. However, some concerns include the lack of face-to-face interaction and potential issues for those not comfortable with technology. ^{1 2 6 7 8}

How is the Coach-guided smartphone delivered CBT program unique compared to other treatments for psoriasis and depression?

This treatment is unique because it delivers cognitive behavioral therapy (CBT) through a smartphone app, making it more accessible and scalable for users. Unlike traditional in-person therapy, this digital approach allows for flexible, on-the-go mental health support, which can be particularly beneficial for those who face barriers to accessing conventional therapy. ^{1 3 9 10 11}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. [2020]

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

CBT for depression: a pilot RCT comparing mobile phone vs. computer. [2022]

3. Germany 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. [2020]

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

Exploring the features of an app-based just-in-time intervention for depression. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Tailored Therapist-Guided Internet-Based Cognitive Behavioral Treatment for Psoriasis: A Randomized Controlled Trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

IMPROVE 1.0: Individual Monitoring of Psoriasis Activity by Regular Online App Questionnaires and Outpatient Visits. [2021]

8. Germany 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Usability, Acceptability, and Adherence Rates of Mobile Application Interventions for Prevention or Treatment of Depression: A Systematic Review. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Depression screening via a smartphone app: cross-country user characteristics and feasibility. [2022]