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Идёт набор NCT07436117

Evaluating the Impact AI Avatar-led Mental Health Interventions for Keeping Employees in Work

Без фазы С лечением Depression

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: Remi, AI avatar-led cognitive behavioural therapy intervention.
Кому может быть актуально
Состояния в реестре: Depression. 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
Великобритания
Следующий шаг
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Обзор

This study will examine whether an artificial intelligence (AI) avatar-led mental health programme can help employees experiencing symptoms of depression. The programme delivers structured, self-guided psychological support over several short sessions that participants complete online over a period of several weeks. Approximately 50-80 adults will take part. Participants will be randomly assigned either to start the AI programme immediately or to continue with their usual support and access the programme later. All participants will complete questionnaires before and after the study period to assess changes in mood, anxiety, and work functioning. Some participants will also be invited to take part in brief interviews to share their experiences of using the programme. The aim of the study is to evaluate whether this AI-based intervention can improve mental health and workplace functioning, and to assess how acceptable and safe it is for use in a working population.

Вмешательства

  • Поведенческое Remi, AI avatar-led cognitive behavioural therapy intervention
    The InsideOut AI programme for low mood is based on principles of Cognitive Behavioral Therapy (CBT), adapted into a self-paced, avatar-led format. Participants in the intervention group will complete six sessions over a four to six-week period, each lasting 10-15 minutes. The sessions will cover the following key components: 1. Session 1-2: Psychoeducation on depression and the role of CBT. 2. Session 3-4: Cognitive restructuring techniques to challenge negative thought patterns. 3. Session 5

Первичные конечные точки

  • Depression (PHQ-9) [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]
Вторичные конечные точки (6)
  • Anxiety (GAD-7) [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]
  • Absenteeism [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]
  • Productivity [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]
  • Concentration at Work [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]
  • Relationships with Colleagues [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]
  • Job Satisfaction [Срок оценки: First measure at baseline, second measure 1 week post-intervention in treatment condition or 6 weeks after baseline in the control condition.]

Критерии участия

Критерии включения

  • Participants will be eligible if they currently experience symptoms of depression (score above 5 on the PHQ-9)
  • Participants should be aged 18 or above.
  • Participants need to be resident in the UK.

Критерии исключения

  • Participants with frequent thoughts of suicide/self-harm will be excluded (scoring above 2 on Question 9 of the PHQ-9 "Thoughts that I would be dead or hurting myself in some way")
  • Participants who are currently undergoing other forms of therapy will be excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • University of Roehampton — London

Идентификаторы

NCT: NCT07436117 · PSYC 25-523

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗