Psoriasis Clinical Trial

Smart Phone Delivered Cognitive Behavioral Therapy for Adults With Psoriasis and Co-Morbid Depression Symptoms

Summary

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.

View Full Description

Full Description

To demonstrate the feasibility and acceptability of coach-guided, smartphone-delivered CBT for depression among adults with psoriasis
To demonstrate the preliminary efficacy of coach-guided, smartphone-delivered CBT on the symptoms of depression and psoriasis

Primary endpoints

Percentage of participants who engage with at least 6/8 (75%) modules
Median Client Satisfaction Questionnaire-8 score at week 8
Change from baseline in PHQ-9 at week 8

Secondary Endpoints

Rate of participant dropout
App acceptability to participants, as measured by the uMARS
Change from baseline in Skindex-16 at week 8
Change from baseline in PSI at week 8
Change from baseline in AAI at week 8
Frequency & severity of related adverse events
The patient perspective on the feasibility and acceptability (qualitative)

Analysis Plan Investigators will assess the feasibility of smartphone-based CBT by reporting the proportion of participants who engaged with at least 75% of the treatment modules and assess patient acceptability with descriptive statistics summarizing the Client Satisfaction Questionnaire scores. Paired t-tests will be used to examine the differences in the pre- and post- treatment PHQ-9 scores, in all patients who complete the baseline study visit. Additionally, secondary outcomes (dropout rates, patient feedback from the Mobile Application Rating Scale, Skindex-16, Psoriasis Symptom Inventory, Appearance Anxiety Inventory) will be reported descriptively. Post-treatment interviews will be transcribed, edited for clarity, coded to identify themes and summarized.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

• Adults aged 18 years of age and older

Dermatologist confirmed diagnosis of psoriasis
Current depression symptoms, defined as a PHQ-9 score of 5 or greater
Current psoriasis symptoms, defined as a scaled score of "mild" on any of the Skindex-16 subscales
Participants must be proficient in English and have access to an Android or iOS smartphone

Exclusion Criteria:

Previous participation in CBT for depression
Current participation in any type of psychotherapy
Those on psychotropic medications must be taking a stable dose for 2 months prior to enrollment and be willing to remain at a stable dose during the 8-week study
Current elevated suicide risk (see Section 5.3 for details)
Individuals who are incarcerated or compulsory detained
Any uncontrolled or poorly controlled chronic medical condition that may interfere with an individual's ability to participate in the clinical trial

Study is for people with:

Psoriasis

Estimated Enrollment:

30

Study ID:

NCT06216691

Recruitment Status:

Recruiting

Sponsor:

Brigham and Women's Hospital

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Liset Chacin
Contact
617-264-5926
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

30

Study ID:

NCT06216691

Recruitment Status:

Recruiting

Sponsor:


Brigham and Women's Hospital

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.