Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
300000 participants
OBSERVATIONAL
2025-09-09
2035-12-31
Brief Summary
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This will allow the investigators to observe the acceptance, engagement, and outcomes of programs using this approach in the treatment of multiple mental health concerns.
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Detailed Description
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This data will allow the researchers to:
1. Assess the adoption, engagement and feasibility of digital care programs for mental distress;
2. Assess the results of digital care programs and compare the costs with the benefits obtained;
3. Correlate the results with participant's demographic and clinical profiles;
4. Examine the impact of mental health and the behavioral modification components of Mind's interventions on disease markers, comorbidities, and productivity;
5. Increase the knowledge on mental distress, namely how mental health distress symptoms progress and respond to digital care programs;
6. Develop new or improved tools to assist clinicians in the management of these disorders and in helping people achieve better mental health.
Design Prospective, observational
Participants This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.
Participants will have access to a digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness
Outcomes The primary outcome will be the evolution of the participant's mental health condition along the program. Depending on the condition, primary and secondary outcome measures vary, but the registry will include, in all cases, a complete characterization of the participant's mental health status, as well as the periodic assessment of: a) performance indicators (through condition-specific tests); b) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); c) compliance; d) patient satisfaction.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation
This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.
Intervention
Digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness.
Interventions
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Intervention
Digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness.
Eligibility Criteria
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Inclusion Criteria
* able to understand study procedures and willing to provide informed consent.
Exclusion Criteria
* self-reported scores of the Patient Health questionnaire-9 (PHQ-9) above 19;
* suffering from any of the following mental health conditions: Schizophrenia, Bipolar Disorder, Alcohol Use Disorder, Substance Use Disorder, Eating Disorder, Post-Traumatic Stress Disorder.
18 Years
ALL
Yes
Sponsors
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Sword Health, SA
INDUSTRY
Responsible Party
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Principal Investigators
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Fernando D Correia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
SWORD HEALTH INC
Locations
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Sword Health
New York, New York, United States
Countries
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Other Identifiers
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SH-OBS-MND-US-01
Identifier Type: -
Identifier Source: org_study_id
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