An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer

Breast Cancer Clinical Trial

Official title:

An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06136923
• Other study ID #: CT-100-D-004
• Status: Completed
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: May 6, 2024

Study information

• Verified date: May 2024
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: May 6, 2024
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• CT-100-D-004-A
Attention Biases App CT-100-D-004-A Digital Neuro-activation and Modulation (DiNaMo) component uses implicit training to redirect and strengthen attention processes. This intervention can help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli.
• CT-100-D-004-B
Attention Biases App CT-100-D-004-B Digital Neuro-activation and Modulation (DiNaMo) component uses implicit training to redirect and strengthen attention processes. This intervention can help improve cognitive capabilities as well as redirect attentional biases to make participants less sensitive to distressing stimuli.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Reported Outcomes	Change from baseline to Week 4 in quality of life as measured by PROMIS-29+2 (Patient Reported Outcomes Measurement Information System)	Baseline to Week 4
Secondary	Change in Pain Severity and Pain Interference	Change from baseline to Week 4 in pain severity and pain interference as measured by the Brief Pain Inventory (BPI)	Baseline to Week 4
Secondary	Change in Pain Catastrophizing Scale	Change from baseline to Week 4 Pain Catastrophizing Scale (PCS) from 0-30+	Baseline to Week 4
Secondary	Change in indication-specific measures MS	Change from baseline to Week 4 in indication-specific measures: Symbol Digit Modalities Test (SDMT) for MS	Baseline to Week 4
Secondary	Change in indication-specific measures Cancer	Change from baseline to Week 4 in indication-specific measures: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) for cancer	Baseline to Week 4
Secondary	Proportion of participants with an improvement	Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score from -5 to 5 at Week 4	Baseline to Week 4
Secondary	Engagement with Study App	Engagement with the Study App as measured by daily time in the Study App	Baseline to Week 4