Smart Phone Delivered Cognitive Behavioral Therapy for Adults with Psoriasis and Co-Morbid Depression Symptoms
Purpose
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.
Conditions
- Psoriasis
- Depressive Symptoms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.
