Overview
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.
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
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