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.
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.
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
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