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Completed

NCT Number: NCT06216691

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.

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Key information

Conditions

Psoriasis Behavior Behavioral Symptoms Depression Depressive Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

  • To demonstrate the feasibility and acceptability of coach-guided, smartphone-delivered CBT for depression among adults with psoriasis
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participants Engagement

    Time frame: from Baseline to 8 Weeks

    Percentage of participants who engage with at least 6/8 (75%) modules within the app

  2. Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: change from baseline to Week 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 .

  3. Patient Health Questionaire-9 (PHQ-9)

    Time frame: Week 8

    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.

Secondary outcomes

  1. Rate of participant dropout

    Time frame: Week 8

    Amount of participants do not complete the study

  2. user Mobile Health Rating Scale (uMARS)

    Time frame: Week 8

    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).

  3. Skindex-16

    Time frame: Week 8

    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).

  4. Appearance Anxiety Inventory (AAI)

    Time frame: Week 8

    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.

  5. Frequency of participants with adverse events

    Time frame: Week 8

    Participants will be asked to describe any new health problems or injuries and developed while participanting in the study.

  6. Psoriasis Symptom Inventory

    Time frame: Week 8

    ): 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Psoriasis Foundation

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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