Digital Therapeutic for Schizophrenia
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Click Therapeutics, Inc.
Stay on your current meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. It seems you can continue your standard care medications while participating.
What data supports the idea that Digital Therapeutic for Schizophrenia is an effective treatment?
The available research shows that smartphone apps for schizophrenia, like the Digital Therapeutic for Schizophrenia, have the potential to improve access to care. However, there is limited data on their effectiveness as many apps are not widely available or frequently updated. Some studies suggest that people with schizophrenia have positive attitudes towards using these apps, and they show promise in terms of acceptability and feasibility. However, more research is needed to confirm their effectiveness compared to other treatments.
12345What safety data exists for the digital therapeutic for schizophrenia?
The research indicates that there is promising evidence for the acceptability, safety, feasibility, and efficacy of smartphone apps for schizophrenia, although detailed reporting on app engagement in trials is limited. The study on mobile-assisted cognitive behavioral therapy for negative symptoms suggests preliminary safety in an open single-arm trial. However, many research apps are not yet available on commercial marketplaces, and there is a need for better translation from research to sustainable interventions.
13456Is the digital treatment for schizophrenia a promising treatment?
Yes, digital treatments for schizophrenia are promising because they can make care more accessible and improve the quality of care. People with schizophrenia have shown positive attitudes towards using smartphone apps for treatment, and these apps can help with self-management skills and symptom monitoring. However, more work is needed to make these apps widely available and ensure they are updated regularly.
13578Eligibility Criteria
This trial is for individuals who have completed the Click Therapeutics Randomized Clinical Trial NCT05853900, have stable housing, and can use a specific Study App on an iPhone (iOS 14+) or Android (OS 10+). They must be able to receive messages and emails, and have internet access. Those with recent drug abuse or serious suicidal ideation are excluded.Inclusion Criteria
It is the owner of, and has regular access to, an email address.
Is willing and able to receive SMS text messages and push messages on their smartphone.
I completed the NCT05853900 study less than a week ago.
+3 more
Exclusion Criteria
Has suicidal ideation or behavior, as assessed by the C-SSRS:
Has not completed the Week 16 Visit (Day 112) in the NCT05853900 study.
I tested positive for certain drugs but not THC, or my use of THC is occasional.
+3 more
Participant Groups
The study tests the continued effectiveness and safety of using the Click Therapeutics Study App as an additional treatment alongside standard care in participants from a previous trial. It's an open label extension meaning everyone gets the app without being compared to a control group.
1Treatment groups
Experimental Treatment
Group I: Arm AExperimental Treatment1 Intervention
Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Click TherapeuticsNew York City, NY
Click TherapeuticsNew York, NY
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Who Is Running the Clinical Trial?
Click Therapeutics, Inc.Lead Sponsor
Boehringer IngelheimIndustry Sponsor
References
Accessibility and availability of smartphone apps for schizophrenia. [2022]App-based interventions have the potential to enhance access to and quality of care for patients with schizophrenia. However, less is known about the current state of schizophrenia apps in research and how those translate to publicly available apps. This study, therefore, aimed to review schizophrenia apps offered on marketplaces and research literature with a focus on accessibility and availability. A search of recent reviews, gray literature, PubMed, and Google Scholar was conducted in August 2022. A search of the U.S. Apple App Store and Google Play App Store was conducted in July 2022. All eligible studies and apps were systematically screened/reviewed. The academic research search produced 264 results; 60 eligible studies were identified. 51.7% of research apps were built on psychosis-specific platforms and 48.3% of research apps were built on non-specific platforms. 83.3% of research apps offered monitoring functionalities. Only nine apps, two designed on psychosis-specific platforms and seven on non-specific platforms were easily accessible. The search of app marketplaces uncovered 537 apps; only six eligible marketplace apps were identified. 83.3% of marketplace apps only offered psychoeducation. All marketplace apps lacked frequent updates with the average time since last update 1121 days. There are few clinically relevant apps accessible to patients on the commercial marketplaces. While research efforts are expanding, many research apps are unavailable today. Better translation of apps from research to the marketplace and a focus on sustainable interventions are important targets for the field.
Smartphone digital phenotyping, surveys, and cognitive assessments for global mental health: Initial data and clinical correlations from an international first episode psychosis study. [2022]To examine feasibility and acceptability of smartphone mental health app use for symptom, cognitive, and digital phenotyping monitoring among people with schizophrenia in India and the United States.
Characterizing Smartphone Engagement for Schizophrenia: Results of a Naturalist Mobile Health Study. [2019]Despite growing interest in smartphone apps for schizophrenia, little is known about how these apps are utilized in the real world. Understanding how app users are engaging with these tools outside of the confines of traditional clinical studies offers an important information on who is most likely to use apps and what type of data they are willing to share.
Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. [2020]Negative symptoms are an important unmet treatment need for schizophrenia. This study is a preliminary, open, single-arm trial of a novel hybrid intervention called mobile-assisted cognitive behavioral therapy for negative symptoms (mCBTn).
Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis. [2023]Individuals with psychosis report favourable attitudes towards psychological interventions delivered via smartphone apps. Evidence for acceptability, safety, feasibility and efficacy is promising but in-depth reporting of app engagement in trials is sparse.
The Functionality, Evidence, and Privacy Issues Around Smartphone Apps for the Top Neuropsychiatric Conditions. [2022]There are more than 325,000 health-related smartphone applications (apps) on the market. To better understand the apps currently on the market for the five most disabling neuropsychiatric conditions, the authors conducted a study investigating their intended uses (target population and intervention), the data collected, and any privacy policies.
Predicting symptom response and engagement in a digital intervention among individuals with schizophrenia and related psychoses. [2023]Despite existing work examining the effectiveness of smartphone digital interventions for schizophrenia at the group level, response to digital treatments is highly variable and requires more research to determine which persons are most likely to benefit from a digital intervention.
Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. [2022]Mobile health (mHealth) technologies have been used extensively in psychosis research. In contrast, their integration into real-world clinical care has been limited despite the broad availability of smartphone-based apps targeting mental health care. Most apps developed for treatment of individuals with psychosis have focused primarily on encouraging self-management skills of patients via practicing cognitive behavioral techniques learned during face-to-face clinical sessions (eg, challenging dysfunctional thoughts and relaxation exercises), reminders to engage in health-promoting activities (eg, exercising, sleeping, and socializing), or symptom monitoring. In contrast, few apps have sought to enhance the clinical encounter itself to improve shared decision-making (SDM) and therapeutic relationships with clinicians, which have been linked to positive clinical outcomes.