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

Mass General Brigham

Status: Active, not recruiting

Conditions: Depressive Symptoms; Psoriasis

Treatments: Other: Coach-guided smartphone delivered CBT program.

Study type: Interventional

Funder types: Other

Identifiers

NCT06216691

2023P001944

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Coach-guided smartphone delivered CBT program

Other group

Description:

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.

Treatment:

Other: Coach-guided smartphone delivered CBT program.