Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Controlled, Single-Blind, Exploratory Basket Study to Evaluate the Effects of a DiNaMo™ Component Training in Adults With Chronic Pain-Related Disorders
Verified date | April 2023 |
Source | Click Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc. (Click).
Status | Completed |
Enrollment | 124 |
Est. completion date | February 6, 2023 |
Est. primary completion date | February 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Meets indication-specific eligibility criteria as reported by the study participant with adequate clinical documentation - Self-reported average pain intensity during the last 7 days of = 3 of 10 on the Numeric rating Scale (NRS scale) associated with the primary indication - Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.) - Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey. - Lives in the United States. - Has an active email address and is willing and able to receive email messages. - Is the sole user of an iPhone with iPhone operating systems (iOS) 14 or later capabilities or a smartphone with an Android operating system (OS) 10 or later capabilities with cellular and/or internet access for the duration of the study period. Exclusion Criteria: - Has a comorbid acute pain condition, such as from current injuries - Participation in a clinical trial (including psychotherapy, mindfulness, cognitive training, or drug treatment) within the last 2 months - Initiation or change in primary disease-specific medication for 30 days prior to entering the study - Self-reported substance use disorder within the past 1 year - Daily use of opioids of 30 MME (Morphine Milligram Equivalents) or more - Substance use disorder within the past 1 year. - Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months. - Participation in a clinical trial within the last 2 months. - Planning to introduce new therapies or change therapies during the study duration - Visual, dexterity or cognitive deficit so severe that precludes the use of an app per investigator judgment. - Severe psychiatric disorder involving a history of psychosis - Other significant medical condition that may confound the interpretation of findings |
Country | Name | City | State |
---|---|---|---|
United States | Click Therapeutics | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Click Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the effect size for changes in pain experience (interference) in the Treatment App group compared to the Digital Control App group | Effect size change as measured by the Numerical Rating Scale (NRS) questionnaire, from the lowest (0) to the highest (10) | Change from Baseline to Week 4 | |
Secondary | To explore the feasibility of remote digital DiNaMo training Study App in participants with chronic pain | Feasibility is measured by using User Experience Questionnaire including engagement and experience with the Study App in participants with chronic pain as measured by metrics such as daily app usage and daily time in the app. The questionnaire will ask questions related to the perceived enjoyment, challenges, and related user experience. | User experience questionnaire of feasibility recorded on baseline and Week 4 | |
Secondary | To estimate the effect size for changes in attention to pain in the Treatment App group compared to the Digital Control App group | Change is measured by the Pain Vigilance and Awareness Questionnaire (PVAQ), from the lowest (0) to the highest (5). | Change from baseline to Week 4 | |
Secondary | To estimate the effect size for changes in pain catastrophizing in the Treatment App group compared to the Digital Control App group | Change is measured by the Pain Catastrophizing Scale (PCS) from the lowest (0) to the highest (4). | Change from baseline to Week 4 | |
Secondary | To estimate the effect size for changes in confidence in dealing with chronic pain in the Treatment App group compared to the Digital Control App group | Change is measured by the Pain Self-efficacy Questionnaire (PSEQ) from the lowest (0) to the highest (6). | Change from baseline to Week 4 |
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