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

NCT06216691 | Completed

• 1 other identifier: 2023P001944
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Depressive Symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Rate of participant dropout

  Week 8

• user Mobile Health Rating Scale (uMARS)

  Week 8

• Skindex-16

  Week 8

• Appearance Anxiety Inventory (AAI)

  Week 8

• Frequency of participants with adverse events

  Week 8

Study Arms (1)

Coach-guided smartphone delivered CBT program

OTHER

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.

Interventions

Coach-guided smartphone delivered CBT program. OTHER

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.

Coach-guided smartphone delivered CBT program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Psoriasis Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Psoriasis; Depression

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 22, 2024
• Study Start: January 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)