Digital Care Programs for Mental Health

SWORD Health

Status: Invitation-only

Conditions: Mental Distress; Mental Resilience

Treatments: Behavioral: Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT07183085

SH-OBS-MND-US-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300,000 participants in 1 patient group

Observation

Description:

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

Treatment:

Behavioral: Intervention