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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Improvement (PGIC) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Activities Performed | Number of total activities performed, including those related to the mindfulness, physical activity, or sleep-related components. | through study completion, an average of 3 months |
| Total Program Activities Time |
Inclusion Criteria:
Exclusion Criteria:
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This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD, PhD | SWORD HEALTH INC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sword Health | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Self-reported Quality of Life | 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?" | 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 | 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. | 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) | Sleep will be assessed using a wearable device, including the total number of hours spent sleeping. | 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. |
Number of minutes spent on activities (aggregated), including those related to the mindfulness, physical activity, or sleep-related components.
| through study completion, an average of 3 months |
| Self-reported satisfaction | 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?") | 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. |
| Average Program Activities Time per Week | Average number of minutes spent on program activities per week, including those related to the mindfulness, physical activity, or sleep-related components. | through study completion, an average of 3 months |