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).
The Study App (CT-100-002) contains a class of Digital Neuro-activation and Modulation (DiNaMo™) mechanisms of action that are part of the Click Neurobehavioral Intervention (CNI) Platform™. DiNaMo™ provide interactive, software based therapeutic components that may be included in a multimodal treatment for developing future digital therapeutics. Chronic pain is a transdiagnostic condition which manifests in patients with diverse underlying pathologies such as rheumatoid arthritis, diabetic neuropathy, fibromyalgia, and irritable bowel syndrome. This basket study aims to evaluate the efficacy, safety, and tolerability of CT-100-002 on measures of pain, pain-related functioning, and mood across multiple indications. The study results will further future clinical development of digital therapeutics comprising DiNaMo™ mechanisms of action.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
124
Study App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy
Placebo App to be used in patients with 1 of the 4 indications of rheumatoid arthritis, fibromyalgia Irritable Bowel Syndrome, Diabetic Neuropathy
Click Therapeutics
New York, New York, United States
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)
Time frame: Change from Baseline to Week 4
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.
Time frame: User experience questionnaire of feasibility recorded on baseline and Week 4
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).
Time frame: Change from baseline to Week 4
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).
Time frame: Change from baseline to Week 4
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).
Time frame: Change from baseline to Week 4
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