Digital Care Programs for Mental Health

NCT07183085 | Enrolling By Invitation

• 1 other identifier: SH-OBS-MND-US-01
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to create a research repository, composed of data collected over the course of digital care programs for mental health distress delivered by Sword Mind to individuals. 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.

Conditions

Mental Distress; Mental Resilience

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Measured through the General Anxiety Disorder-7 (GAD-7), a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.

  Assessed at baseline (upon initiation of the program) and then at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

• Depression

  Measured through the Patient Health Questionnaire-9 (PHQ-9), a 9-item scale (scores 0-27). Higher scores mean higher depression levels.

  Assessed at baseline (upon initiation of the program) and then at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

Secondary Outcomes (4)

• Overall Improvement (PGIC)

  Assessed at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

• Self-reported Quality of Life

  Assessed at baseline (upon initiation of the program) and then at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

• Work productivity and absenteeism

  Assessed at baseline (upon initiation of the program) and then at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

• Sleep Duration (wearable-measured)

  Recorded daily. Outcomes summarized at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

Other Outcomes (4)

• Program Activities Performed

  through study completion, an average of 3 months

• Total Program Activities Time

  through study completion, an average of 3 months

• Self-reported satisfaction

  Assessed at regular intervals (5, 9, 15, 21, and 27 days). Additional follow-up assessments may be undertaken at other follow-up times: 3 months, 6 months and 12 months.

Study Arms (1)

Observation

This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

Digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness.

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.

You may qualify if:

• years old and above;
• able to understand study procedures and willing to provide informed consent.

You may not qualify if:

• suicidal ideation with plan in the past 6 months;
• 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.

Sponsors & Collaborators

• Sword Health, SA: lead

Study Sites (1)

Sword Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Fernando D Correia, MD, PhD

  SWORD HEALTH INC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 19, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)