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Enrolling by Invitation

NCT Number: NCT07183085

Digital Care Programs for Mental Health

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.

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Key information

Conditions

Mental Distress Mental Resilience

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sword Health

New York, 10016, United States

About this study

Purpose This patient registry was designed as 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 data will allow the researchers to:

  • Assess the adoption, engagement and feasibility of digital care programs for mental distress;
  • Assess the results of digital care programs and compare the costs with the benefits obtained;
  • Correlate the results with participant's demographic and clinical profiles;
  • Examine the impact of mental health and the behavioral modification components of Mind's interventions on disease markers, comorbidities, and productivity;
  • Increase the knowledge on mental distress, namely how mental health distress symptoms progress and respond to digital care programs;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Intervention

Behavioral

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

Primary outcomes

  1. Anxiety

    Time frame: 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.

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

  2. Depression

    Time frame: 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.

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

Secondary outcomes

  1. Overall Improvement (PGIC)

    Time frame: 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.

    Measured through the Patient Global Impression of Change (PGIC) questionnaire. Scores reflect the participant's perceived overall improvement (range 1-7), with higher scores indicating greater improvement.

  2. Self-reported Quality of Life

    Time frame: 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.

    Assessed through the question "On a scale of 0-100, how would you rate your overall health, with 0 being the worst health imaginable and 100 the best health imaginable?"

  3. Work productivity and absenteeism

    Time frame: 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.

    Measured through Work Productivity and Activity Impairment Questionnaire (WPAI) assessed by the sub-scores: WPAI overall (combining presenteeism and absenteeism), WPAI work (presenteeism), WPAI time (absenteeism) and WPAI activities (activities of daily living impairment) (scores 0-100%). Higher scores mean greater impairment.

  4. Sleep Duration (wearable-measured)

    Time frame: 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.

    Sleep will be assessed using a wearable device, including the total number of hours spent sleeping.

Other outcomes

  1. Program Activities Performed

    Time frame: through study completion, an average of 3 months

    Number of total activities performed, including those related to the mindfulness, physical activity, or sleep-related components.

  2. Total Program Activities Time

    Time frame: through study completion, an average of 3 months

    Number of minutes spent on activities (aggregated), including those related to the mindfulness, physical activity, or sleep-related components.

  3. Self-reported satisfaction

    Time frame: 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.

    Measured through the Net Promoter Score question collected at end of program: "On a scale from 0 to 10, how likely are you to recommend SWORD's programs to a friend or family member?")

  4. Average Program Activities Time per Week

    Time frame: through study completion, an average of 3 months

    Average number of minutes spent on program activities per week, including those related to the mindfulness, physical activity, or sleep-related components.

Sponsors and collaborators

Lead sponsor

Sword Health, SA

Industry

Registry information

Official study title

Digital Care Programs for Mental Health: a Large-scale, Multi-disorder, Observational Study

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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