Clinical trial NCT06216691: Smart Phone Delivered Cognitive Behavioral Therapy for Adults with Psoriasis and Co-Morbid Depression Symptoms
Official title: Smart Phone Delivered Cognitive Behavioral Therapy for Adults with Psoriasis and Co-Morbid Depression Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Depressive Symptoms
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participants Engagement
timeFrame: from Baseline to 8 Weeks
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: change from baseline to Week 8
measure: Patient Health Questionaire-9 (PHQ-9)
timeFrame: Week 8
Secondary outcomes:
measure: Rate of participant dropout
timeFrame: Week 8
measure: user Mobile Health Rating Scale (uMARS)
timeFrame: Week 8
measure: Skindex-16
timeFrame: Week 8
measure: Appearance Anxiety Inventory (AAI)
timeFrame: Week 8
measure: Frequency of participants with adverse events
timeFrame: Week 8
measure: Psoriasis Symptom Inventory
timeFrame: Week 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: