NCT06216691

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. To demonstrate the feasibility and acceptability of coach-guided, smartphone-delivered CBT for depression among adults with psoriasis 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

• Psoriasis
• Depressive Symptoms

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-01-22
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States