Mental DistressNCT07183085
Digital Care Programs for Mental Health
An observational study of Mental Distress and Mental Resilience, run by Sword Health, SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Distress, Mental Resilience
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to Dec 2035
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.
Who may be able to join
- 18 years old and above;
- able to understand study procedures and willing to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Digital Care Programs for Mental Health: a Large-scale, Multi-disorder, Observational Study
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.
Read the detailed description
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.
- Conditions
- Mental Distress, Mental Resilience
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Observation | This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Measured through the General Anxiety Disorder-7 (GAD-7), a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.
Measured: 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.
Measured: 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)
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.
Measured: 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 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?"
Measured: 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.
Measured: 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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start9 Sep 2025
- Primary completionSep 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando D Correia, MD, PhD, Principal investigator, SWORD HEALTH INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183085
- Sponsor's protocol ID
- SH-OBS-MND-US-01
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Care Programs for Mental Health: a Large-scale, Multi-disorder, Observational Study
- ClinicalTrials.gov ID
- NCT07183085
- Acronym / sponsor ID
- SH-OBS-MND-US-01
- Conditions
- Mental Distress, Mental Resilience
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Behavioral: InterventionThis program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This program is designed to support individuals experiencing mental distress to improve overall wellbeing and mood symptom improvement.
Key inclusion criteria (2 listed)
- 18 years old and above;
- able to understand study procedures and willing to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionDigital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness. | Behavioural | Observation |
Primary outcome
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando D Correia, MD, PhD principal investigator
SWORD HEALTH INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Distress and Mental Resilience, run by Sword Health, SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.