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Набор по приглашению NCT07183085

Digital Care Programs for Mental Health

Наблюдательное Mental Distress Mental Resilience

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intervention.
Кому может быть актуально
Состояния в реестре: Mental Distress, Mental Resilience. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Anxiety [Срок оценки: 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 [Срок оценки: 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.]
Вторичные конечные точки (4)
  • Overall Improvement (PGIC) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Sword Health — New York

Идентификаторы

NCT: NCT07183085 · SH-OBS-MND-US-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗