Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training
A Randomized, Controlled, Single-Blind, Exploratory Basket Study to Evaluate the Effects of a DiNaMo™ Component Training in Adults With Chronic Pain-Related Disorders
1 other identifier
interventional
124
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Oct 2022
Shorter than P25 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2023
CompletedApril 26, 2023
April 1, 2023
4 months
October 6, 2022
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
To explore the feasibility of remote digital DiNaMo training Study App in participants with chronic pain
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 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 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 from baseline to Week 4
Study Arms (2)
DiNaMo Study App
ACTIVE COMPARATORRandomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App
Digital Control App
PLACEBO COMPARATORRandomization ratio as 3 DiNaMo Study Apps: 1 Digital Control App
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Click Therapeutics
New York, New York, 10013, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaheen Lakhan, MD, PhD, FAAN
Click Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Single blind, randomized into 3:1 ratio (3 DiNaMo Study Apps of 4 indications: 1 Digital Control App)
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 10, 2022
Study Start
October 10, 2022
Primary Completion
February 6, 2023
Study Completion
February 6, 2023
Last Updated
April 26, 2023
Record last verified: 2023-04