Smartphone CBT for Psoriasis and Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Disqualifiers: Previous CBT, Psychotherapy, Suicide risk, others
No Placebo Group
Approved in 1 Jurisdiction
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?
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.12678
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.1391011
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 18 years old or older.
I am currently experiencing symptoms of depression.
Participants must be proficient in English and have access to an Android or iOS smartphone
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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.
See 3 more
Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Coach-guided smartphone delivered CBT programExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
National Psoriasis FoundationCollaborator
References
Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. [2020]A growing number of psychological interventions are delivered via smartphones with the aim of increasing the efficacy and effectiveness of these treatments and providing scalable access to interventions for improving mental health. Most of the scientifically tested apps are based on cognitive behavioral therapy (CBT) principles, which are considered the gold standard for the treatment of most mental health problems.
CBT for depression: a pilot RCT comparing mobile phone vs. computer. [2022]This paper reports the results of a pilot randomized controlled trial comparing the delivery modality (mobile phone/tablet or fixed computer) of a cognitive behavioural therapy intervention for the treatment of depression. The aim was to establish whether a previously validated computerized program (The Sadness Program) remained efficacious when delivered via a mobile application.
Smartphone applications for depression: a systematic literature review and a survey of health care professionals' attitudes towards their use in clinical practice. [2020]Smartphone applications ("apps") may contribute to closing the treatment gap for depression by reaching large populations at relatively low costs. The general public seems open towards the use of apps for mental disorders but less is known about the attitudes of health care professionals. Therefore, the aim of this study was to examine the available evidence on the effectiveness of apps for depression and to explore the attitudes of health care professionals towards their use in practice. A systematic literature search was performed aimed at studies utilizing smartphone applications for depression. In addition, a survey was conducted to explore health care professionals' attitudes towards using these treatment apps in clinical practice. Twelve articles were identified in the systematic literature review. All included trials reported a decline in depressive symptoms after the intervention periods. In the survey, 72 health care professionals participated. Significant differences were found between the level of technology experience and how much the health care professional would consider the use of mobile applications in clinical practice. Survey participants reported openness towards therapeutic app use but very little knowledge and experience in the field. Apps appear to be a promising self-management tool for reducing depressive symptoms. Despite some concerns, health care professionals' attitudes towards the use of smartphone applications in clinical practice are quite positive. The provision of information on the potential benefits of e-health interventions as well as the training of professionals in the application of new technologies may increase health care professionals' awareness and knowledge about mobile apps for the treatment of mental disorders.
Exploring the features of an app-based just-in-time intervention for depression. [2021]Technological advancements make it possible to deliver depression interventions via smartphone applications ("Apps"), including those that deliver content "just-in-time" (e.g., in response to acute negative mood states). This study examined whether an app-based just-in-time intervention (ImproveYourMood+) decreased depressive symptoms, and whether the following features were related to symptom improvement: micro-intervention content, mood monitoring, and just-in-time prompts to use content.
[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]Computer-delivered Cognitive Behavioral Therapies (C-CBT) are emerging as therapeutic techniques which contribute to overcome the barriers of health care access in adult populations with depression. The C-CBTs provide CBT techniques in a highly structured format comprising a number of educational lessons, homework, multimedia illustrations and supplementary materials via interactive computer interfaces. Programs are often administrated with a minimal or regular support provided by a clinician or a technician via email, telephone, online forums, or during face-to-face consultations. However, a lot of C-CBT is provided without any therapeutic support. Several reports showed that C-CBTs, both guided or unguided by a therapist, may be reliable and effective for patients with depression, and their use was recommended as part of the first step of the clinical care. The aim of the present qualitative review is to describe the operational format and functioning of five of the most cited unguided C-CBT programs for depression, to analyze their characteristics according to the CBT's principles, and to discuss the results of the randomized clinical trials (RCT) conducted to evaluate its effectiveness, adherence and user's experience.
Tailored Therapist-Guided Internet-Based Cognitive Behavioral Treatment for Psoriasis: A Randomized Controlled Trial. [2022]Patients with somatic conditions, such as psoriasis, frequently suffer from high burden of their disease in daily life and might benefit from internet-based cognitive behavioral therapy (ICBT) tailored to their adjustment problems. The aim of this multicenter randomized controlled trial was to examine the effects of therapist-guided, individually tailored ICBT in a clinical sample of patients with psoriasis.
IMPROVE 1.0: Individual Monitoring of Psoriasis Activity by Regular Online App Questionnaires and Outpatient Visits. [2021]Smartphone apps gain more and more importance in supporting management of chronic diseases. Psoriasis is a highly prevalent, lifelong chronic inflammatory skin disease with a high impact on patient's quality of life. Disease management includes regular topical and systemic treatment of skin lesions as well as co-treatment of metabolic and psychologic disorders. In this study, we investigated the potential of a new smartphone app (IMPROVE 1.0) for individual monitoring of disease activity and disease influencing factors. Twelve out of 50 psoriasis patients asked for study participation performed self-assessment of psoriasis severity, life quality, and stress scores using the app over a period of 1 year. Every 2 months, study participants were carefully examined by a dermatologist in order to control the quality of app-reported data. We found that psoriasis severity and life quality values as entered in the app closely correlate to physician's examination. Furthermore, we detected strong correlations of disease activity with life quality and psoriasis serum biomarker. Temporal relations between psoriasis aggravation and previous changes of lifestyle factors, such as increased stress levels, were observed in individual patients, indicating a high potential for preventive interventions in future psoriasis apps. The vast majority of study participants evaluated IMPROVE 1.0 app positively and wish to include the app into their daily life. Hence, we demonstrate that smartphone apps are a useful tool to raise self-awareness for the dimensions of complex diseases and fully integrate psoriasis patients into individual disease management. These data are important to develop more advanced digital tools supporting the management of chronic diseases in the future.
What patients think about E-health: patients' perspective on internet-based cognitive behavioral treatment for patients with rheumatoid arthritis and psoriasis. [2021]In the past decade, the use of internet-based cognitive behavioral treatments (internet-based CBT) for a wide range of patients has grown intensively. Incorporating the patients' opinions and perspective into new health care innovations might improve the quality and applicability of these innovations, as high dropout rates and low attrition are the often-reported concerns in E-health research. Most studies to date have examined patient perspectives on specific internet-based interventions that patients had participated in, and not the views of the general public. The current paper explores the perspective of patients with rheumatoid arthritis and psoriasis on internet-based CBT for these patient groups. In total, 100 patients (55 % male) participated in a semi-structured telephone interview about internet-based CBT, including questions about possible advantages and disadvantages and the readiness to participate in this kind of treatment. Most patients (78 %) were prepared to participate in internet-based CBT. Patients endorsed the advantages (57 %) more often than the disadvantages (34 %). The ease of internet-based CBT and the time saved were especially appealing to patients. Main disadvantages according to patients are that not all patients will be reached due to computer illiteracy and the lack of face-to-face interaction with the therapist. The results suggest that, from the patients' perspective, internet-based CBT is a promising health care development. Further research into aspects such as therapist interaction and enhancing computer literacy might contribute to an effective way of E-health care delivery in the future.
Evaluating Commercially Available Mobile Apps for Depression Self-Management. [2022]Clinical depression affects 17.3 million adults in the U.S. However, 37% of these adults receive no treatment, and many symptoms remain unmanaged. Mobile health apps may complement in-person treatment and address barriers to treatment, yet their quality has not been systematically appraised. We conducted a systematic review of apps for depression by searching in three major app stores. Apps were selected using specific inclusion and exclusion criteria. The final apps were downloaded and independently evaluated using the Mobile Application Rating Scale (MARS), IMS Institute for Healthcare Informatics functionality score, and six features specific to depression self-management. Mobile health apps for depression self-management exhibit a wide range of quality, but more than half (74%) of the apps had acceptable quality, with 32% having MARS scores ≥ 4.0 out of 5.0. These high scoring apps indicate that mobile apps have the potential to improve patient self-management, treatment engagement, and mental health outcomes.
Usability, Acceptability, and Adherence Rates of Mobile Application Interventions for Prevention or Treatment of Depression: A Systematic Review. [2021]Mobile health applications (apps) have been growing as a new frontier in mental health care delivery. The objective of the current systematic review was to summarize the evidence regarding usability, acceptability, and adherence rates of mobile app interventions for prevention or treatment of depression. A literature search was conducted in relevant databases, including PubMed, PsycINFO, and Embase, for articles published between January 1, 2009, and August 1, 2019. Key terms used for searching included depression AND smartphone OR mobile AND application AND acceptability OR feasibility. Based on a full-text examination, seven studies were included for review. All studies were conducted in developed countries and five studies were developing a mobile app for depression treatment. The current study highlights the need for developers of mobile apps for individuals with mental health care needs to consider user acceptability and adherence rates. Innovation in designing a mobile app for individuals with depression is needed to improve the adherence rates of users. [Journal of Psychosocial Nursing and Mental Health Services, 59(2), 41-47.].
Depression screening via a smartphone app: cross-country user characteristics and feasibility. [2022]Smartphone applications (apps) have the potential to be valuable self-help interventions for depression screening. However, information about their feasibility and effectiveness and the characteristics of app users is limited. The aim of this study is to explore the uptake, utilization, and characteristics of voluntary users of an app for depression screening.