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

Sponsor

Click Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06136923

Collaborator

(none)

180

Enrollment

Location

Arms

2.1

Anticipated Duration (Months)

84.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Lung Cancer Breast Cancer	Device: CT-100-D-004-A Device: CT-100-D-004-B	N/A

Detailed Description

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 (Crombez 2013). Similarly, hypersensitivity to threat-related stimuli can exacerbate anxiety (Bar-Haim 2010).

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 19, 2023

Anticipated Primary Completion Date :

Nov 23, 2023

Anticipated Study Completion Date :

Dec 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multiple Sclerosis with Mobility Limitations Study App A Cognitive Training App CT-100-D-004-A Digital Neuro-activation and Modulation (DiNaMo) study app for multiple sclerosis with mobility limitations	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.
Other: Multiple Sclerosis with Mobility Limitations Study App B Cognitive Training App CT-100-D-004-B Digital Neuro-activation and Modulation (DiNaMo) study app for multiple sclerosis with mobility limitations	Device: 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.
Experimental: Multiple Sclerosis without Mobility Limitations Study App A Cognitive Training App CT-100-D-004-A Digital Neuro-activation and Modulation (DiNaMo) study app for multiple sclerosis without mobility limitations	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.
Other: Multiple Sclerosis without Mobility Limitations Study App B Cognitive Training App CT-100-D-004-B Digital Neuro-activation and Modulation (DiNaMo) study app for multiple sclerosis without mobility limitations	Device: 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.
Experimental: Oncology Breast Cancer Study App A Cognitive Training App CT-100-D-004-A Digital Neuro-activation and Modulation (DiNaMo) study app for breast cancer.	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.
Other: Oncology Breast Cancer Study App B Cognitive Training App CT-100-D-004-B Digital Neuro-activation and Modulation (DiNaMo) study app for breast cancer.	Device: 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.
Experimental: Oncology Lung Cancer Study App A Cognitive Training App CT-100-D-004-A Digital Neuro-activation and Modulation (DiNaMo) study app for lung cancer.	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.
Other: Oncology Lung Cancer Study App B Cognitive Training App CT-100-D-004-B Digital Neuro-activation and Modulation (DiNaMo) study app for lung cancer.	Device: 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.

Outcome Measures

Primary Outcome Measures

Change in Patient Reported Outcomes [Baseline to Week 4]
Change from baseline to Week 4 in quality of life as measured by PROMIS-29+2 (Patient Reported Outcomes Measurement Information System)

Secondary Outcome Measures

Change in Pain Severity and Pain Interference [Baseline to Week 4]
Change from baseline to Week 4 in pain severity and pain interference as measured by the Brief Pain Inventory (BPI)
Change in Pain Catastrophizing Scale [Baseline to Week 4]
Change from baseline to Week 4 Pain Catastrophizing Scale (PCS) from 0-30+
Change in indication-specific measures MS [Baseline to Week 4]
Change from baseline to Week 4 in indication-specific measures: Symbol Digit Modalities Test (SDMT) for MS
Change in indication-specific measures Cancer [Baseline to Week 4]
Change from baseline to Week 4 in indication-specific measures: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) for cancer
Proportion of participants with an improvement [Baseline to Week 4]
Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score from -5 to 5 at Week 4
Engagement with Study App [Baseline to Week 4]
Engagement with the Study App as measured by daily time in the Study App

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Fluent in written and spoken English, confirmed by ability to read, understand, and sign the informed consent form
Lives in the United States
Adult between 22 and 65 years old
Meets indication-specific including criteria, as reported by the study participant with adequate clinical documentation (to be provided to the study team upon request)
Has an active email address and is willing and able to receive and respond to email messages
Has access to an internet connection during the study duration
Has an active PayPal account to receive study compensation, or is willing to create one
Willing and able to comply with study protocol and assessments
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
Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone
Has access to operating headphones

Exclusion Criteria:

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

Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based reaction time-based activity per investigator judgment
Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder, severe personality disorders)
Psychiatric hospitalization in the past 6 months
Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months
Initiation or change in primary disease-specific medication within 30 days prior to entering the study
Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the study duration (6 weeks)
Anticipating a change in current pharmacological or psychotherapy treatment regimen during the study period (6 weeks)
Self-reported substance use disorder within the past 1 year
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)
Mild, moderate, severe or profound unilateral or bilateral hearing loss