Clinical trial NCT06136923: An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer
Official title: An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lung Cancer
Breast Cancer
Keywords: Prescription digital therapeutic (PDT)
Software as a Medical Device (SaMD)
Smartphone app
Attention Biases
Cognition
Multiple Sclerosis
Lung Cancer
Breast Cancer
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 194
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo) components. DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self-processing) to optimally improve a participant's health.

Detailed description: CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo) components. DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self-processing) to optimally improve a participant's health.

Targeted cognitive training is used to reduce symptoms relevant to multiple sclerosis (MS) and cancer. Biases to direct attention towards or away from certain stimuli can exacerbate a variety of symptoms in many different indications. For example, in chronic pain conditions, patients are more attentive to pain-related stimuli, which can lead to hypersensitization. Similarly, hypersensitivity to threat-related stimuli can exacerbate anxiety.

In this treatment, users are trained to re-orient attention away from negative stimuli, such as pain- or threat-related stimuli.

Eligibility criteria: Inclusion Criteria:

* A participant will be eligible for entry into the study if all of the following criteria are met:

  1. Fluent in written and spoken English, confirmed by ability to read, understand, and sign the informed consent form
  2. Lives in the United States
  3. Adult between 22 and 65 years old
  4. Meets indication-specific including criteria, as reported by the study participant with adequate clinical documentation (to be provided to the study team upon request)
  5. Has an active email address and is willing and able to receive and respond to email messages
  6. Has access to an internet connection during the study duration
  7. Has an active PayPal account to receive study compensation, or is willing to create one
  8. Willing and able to comply with study protocol and assessments
  9. Is the sole user of an iPhone with an iPhone operating system (iOS) version 14 or later or a smartphone with an Android operating system (OS) version 10 or later for the duration of the study
  10. Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone
  11. Has access to operating headphones

Exclusion Criteria:

* A participant will not be eligible for study entry if any of the following criteria are met:

  1. Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based reaction time-based activity per investigator judgment
  2. Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder, severe personality disorders)
  3. Psychiatric hospitalization in the past 6 months
  4. Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months
  5. Initiation or change in primary disease-specific medication within 30 days prior to entering the study
  6. Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the study duration (6 weeks)
  7. Anticipating a change in current pharmacological or psychotherapy treatment regimen during the study period (6 weeks)
  8. Self-reported substance use disorder within the past 1 year
  9. Severe neurological disorders impairing brain function (e.g., previous stroke, dementia, primary brain function, brain metastases, Alzheimer's disease, Parkinson's disease, history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities)
  10. Mild, moderate, severe or profound unilateral or bilateral hearing loss

Primary outcomes:
measure: Change in Patient Reported Outcomes
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change in Pain Severity and Pain Interference
timeFrame: Baseline to Week 4
measure: Change in Pain Catastrophizing Scale
timeFrame: Baseline to Week 4
measure: Change in indication-specific measures MS
timeFrame: Baseline to Week 4
measure: Change in indication-specific measures Cancer
timeFrame: Baseline to Week 4
measure: Proportion of participants with an improvement
timeFrame: Baseline to Week 4
measure: Engagement with Study App
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan
role: STUDY_DIRECTOR
References: