Smart Phone Delivered Cognitive Behavioral Therapy for Adults With Psoriasis and Co-Morbid Depression Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Depressive Symptoms
• Intervention / Treatment: Other: Coach-guided smartphone delivered CBT program.

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liset Chacin; Phone Number: 617-264-5926; Email: lchacin@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Liset Chacin; Phone Number: 617-264-5926; Email: lisetchacin@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Engagement	Percentage of participants who engage with at least 6/8 (75%) modules within the app	from Baseline to 8 Weeks
Client Satisfaction Questionnaire-8 (CSQ-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 .	change from baseline to Week 8
Patient Health Questionaire-9 (PHQ-9)	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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participant dropout	Amount of participants do not complete the study	Week 8
user Mobile Health Rating Scale (uMARS)	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).	Week 8
Skindex-16	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).	Week 8
Appearance Anxiety Inventory (AAI)	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.	Week 8
Frequency of participants with adverse events	Participants will be asked to describe any new health problems or injuries and developed while participanting in the study.	Week 8
Psoriasis Symptom Inventory	): 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.	Week 8

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Psoriasis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Skin Diseases, Papulosquamous; Depression; Psoriasis
• Other Study ID Numbers: 2023P001944

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No