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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216691
• Other study ID #: 2023P001944
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: Liset Chacin
• Phone: 617-264-5926
• Email: lchacin[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Psoriasis

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Psoriasis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Engagement	Percentage of participants who engage with at least 6/8 (75%) modules within the app	from Baseline to 8 Weeks
Primary	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
Primary	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	Rate of participant dropout	Amount of participants do not complete the study	Week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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