Smart Phone Delivered Cognitive Behavioral Therapy for Adults With Psoriasis and Co-Morbid Depression Symptoms
NCT ID: NCT06216691
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-01
2025-12-31
Brief Summary
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Detailed Description
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2. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Coach-guided smartphone delivered CBT program
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.
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.
Interventions
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Coach-guided smartphone delivered CBT program.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Psoriasis Foundation
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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John Barbieri
Assistant Professor
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2023P001944
Identifier Type: -
Identifier Source: org_study_id
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