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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06216691
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Brigham and Women's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Depressive Symptoms
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Liset Chacin

lisetchacin@bwh.harvard.edu

617-264-5926

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