Digital Care Programs for Mental Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention.
- Who it may be relevant to
- Registry conditions: Mental Distress, Mental Resilience. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Care Programs for Mental Health: a Large-scale, Multi-disorder, Observational Study
Overview
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:
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.
Interventions
- Behavioral Intervention
Digital mental health program incorporating personalized physical and mental health exercises focused on physical activity, sleep hygiene, and mindfulness.
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Sword Health — New York
Identifiers
NCT: NCT07183085 · SH-OBS-MND-US-01