Psoriasis Clinical Trial
Official title:
Smart Phone Delivered Cognitive Behavioral Therapy for Adults With Psoriasis and Co-Morbid Depression Symptoms
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.
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. ;
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