Depressive Symptoms, Psoriasis
Conditions
Brief 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.
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.
Interventions
OTHERCoach-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.
Sponsors
Brigham and Women's Hospital
National Psoriasis Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Engagement | from Baseline to 8 Weeks | Percentage of participants who engage with at least 6/8 (75%) modules within the app |
| Client Satisfaction Questionnaire-8 (CSQ-8) | change from baseline to Week 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 . |
| Patient Health Questionaire-9 (PHQ-9) | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participant dropout | Week 8 | Amount of participants do not complete the study |
| user Mobile Health Rating Scale (uMARS) | Week 8 | 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). |
| Skindex-16 | Week 8 | 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). |
| Appearance Anxiety Inventory (AAI) | Week 8 | 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. |
| Frequency of participants with adverse events | Week 8 | Participants will be asked to describe any new health problems or injuries and developed while participanting in the study. |
| Psoriasis Symptom Inventory | Week 8 | ): 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. |
Countries
United States
Outcome results
None listed