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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Participants Engagement
Percentage of participants who engage with at least 6/8 (75%) modules within the app
Time frame: from Baseline to 8 Weeks
Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is an 8 item, self-reported questionnaire that measures satisfaction with clinical services received on a 1-4 scale. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction .
Time frame: change from baseline to Week 8
Patient Health Questionaire-9 (PHQ-9)
The PHQ-9 is a widely used, reliable, and valid self-report measure of depression severity, It includes nine Likert scale items ranging from 0 (not at all) to 3 (every day), where higher scores indicate more severe depressive symptoms.
Time frame: Week 8
Rate of participant dropout
Amount of participants do not complete the study
Time frame: Week 8
user Mobile Health Rating Scale (uMARS)
The uMARS is a 20-item measure provides reliable measure of app quality in target users. It includes 4 objective quality subscales-engagement, functionality, aesthetics, and information quality and 1 subjective quality subscale. Each feature is rated on a scale from 1 (inadequate) to 5 (excellent).
Time frame: Week 8
Skindex-16
The Skindex-16 is a brief patient reported outcome that measures functioning, emotions and symptoms associated with chronic skin diseases. Each item is assessed on a 7-point Likert scale and all responses are transformed to a linear scale of 100. The over all score ranges from 0 (no effect) to 100 (effect experienced all the time).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 8
Appearance Anxiety Inventory (AAI)
The AAI is a 10 item self-report questionnaire assessing the frequency of cognitive processes (e.g., rumination, self-focused attention) and behavioral responses (e.g. social avoidance, appearance checking) in Body Dysmorphic Disorder (BDD). Individuals respond to items on a 5-point Likert Scale (0= not all to 4= all the time) and a total score is obtained by summing all the items (range is 0 to 40). The reliable change score is 7 and above.
Time frame: Week 8
Frequency of participants with adverse events
Participants will be asked to describe any new health problems or injuries and developed while participanting in the study.
Time frame: Week 8
Psoriasis Symptom Inventory
): The PSI is an eight-item patient-reported outcome measure for assessing severity of plaque psoriasis symptoms including itch, redness, scaling, burning, cracking, stinging, flaking, and pain). Each item is scored on a 5-point Likert scale where high score indicates more severe symptoms.
Time frame: Week 8