Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood
A Randomized Exploratory Basket Study to Evaluate the Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms in Adult Participants With a Primary Non-DSM-5 Diagnosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- CT-100 DiNaMo
Placebo
- Care-as-Usual
What it measured
Main measures
PROMIS Item Bank v2.0 - Cognitive Function - Short Form 8a (PROMIS-CF)
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Thinking and memory
Other measures (4)
Patient-reported Quality-of-Life (QoL) as measured by the PROMIS-29 in the Study App intervention group compared to a Care-As-Usual control group
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Thinking and memoryFatiguePainMood and sleepQuality of life (reported by participants)Global Rating of Change (GRC-Cognition and GRC-Mood)
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Thinking and memoryMood and sleepChanges in indication-specific measures of Symbol Digit Modalities Test (SDMT) in Multiple Sclerosis (only)
Baseline (Day 1) corrected change of intervention vs, Care-As-Usual on Day 21
Thinking and memoryChanges in indication-specific measures of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) in Cancer (Breast/Lung; only).
Baseline (Day 1) corrected change of intervention vs. Care-As-Usual on Day 21
Thinking and memoryQuality of life (reported by participants)
Who could take part
MS (type not specified) · 22 to 75
Show the full criteria
Inclusion criteria
A participant will be eligible for entry into the study if all the following criteria are met: 1. Age ranges in years: 22-52 for Multiple Sclerosis, 35-65 for Cancer (Breast or Lung), and 45-75 for Mild Cognitive Impairment. 2. Diagnosis of indication under study (Multiple Sclerosis, Cancer - Breast or Lung, Mild Cognitive Impairment) 3. Self-reported cognitive impairment and mood symptoms that began in the context of the primary indication under study. 4. Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.) 5. Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey. 6. Lives in the United States. 7. Has an active email address and is willing and able to receive email messages. 8. Is the sole user of an iPhone or a smartphone with an Android operating system, and with cellular and/or internet access for the duration of the study period.
Exclusion criteria
A participant is excluded from the study if any of the following criteria apply: 1. Physician-diagnosed insomnia in the Screening Survey. 2. Cognitive impairment/mood symptoms or clinical diagnosis of depression attributed to a condition other than the underlying medical condition. 3. Is currently pregnant or breastfeeding. 4. Substance use disorder within the past 1 year. 5. Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months. 6. Participation in a clinical trial within the last 3 months. 7. Anticipates a lifestyle change or change in current treatment during the study period that could affect cognitive functioning. 8. Visual, dexterity or cognitive deficit so severe that precludes the use of an app. 9. Severe neurological disorders impairing brain function. 10. Psychiatric hospitalization in the past 6 months.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
CT-100 is a platform that provides an interactive, software based therapeutic component 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.
Papers
Loading reviews and guidelines…
History
Started
May 2022
Main results due
Sept 2022
Finished
Sept 2022