Smart Phone Delivered Cognitive Behavioral Therapy for Adults with Psoriasis and Co-Morbid Depression Symptoms
- Conditions
- Depressive SymptomsPsoriasis
- Interventions
- Other: Coach-guided smartphone delivered CBT program.
- Registration Number
- NCT06216691
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
-
• 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Coach-guided smartphone delivered CBT program 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
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.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States