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Идёт набор NCT06967922

Impact of Analytic-integrative Cognitive Behavioural Therapy on Acute Insomnia Disorder (Stress)

Без фазы С лечением Acute Insomnia Disorder

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: Analytic-Integrative Cognitive Behavioural Therapy, Sleep hygiene education.
Кому может быть актуально
Состояния в реестре: Acute Insomnia Disorder. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Analytic-integrative Cognitive Behavioural Therapy for Acute Insomnia Disorder (Stress)

Обзор

The main objective of this study, conducted in a population with acute insomnia disorder (stress), was to investigate the efficacy of Analytic-Integrative Cognitive Behavioural Therapy in the treatment of acute insomnia disorder (stress).

Подробное описание

Acute insomnia disorder, also known as short-term insomnia disorder, is basically characterised by difficulties with short-term sleep onset and maintenance and results in feelings of sleep dissatisfaction. When insomnia arises in response to a stressful life event (painful loss of a loved one, major illness, or divorce), associated features may include anxiety, worry, sadness, or depression related to the specific stressor. Medications are a common form of treatment for acute insomnia disorders, and while they may improve the patient's clinical symptoms, the overall results are not very satisfactory. Cognitive behavioural therapy, as a non-pharmacological treatment, has become the first-line recommended solution in the insomnia treatment guidelines of China and the United States, which can correct patients' wrong sleep cognition and bad sleep habits, establish correct sleep-wake cognition, and also improve mental health. Compared with sedative-hypnotic medications, it has no adverse reactions and does not affect daytime function, making it a green and safe treatment method. Based on the exact efficacy of cognitive behavioural therapy in improving insomnia, and also considering the diverse causes of acute insomnia disorder (stress), we analyse-integrate the analysis of the patient's specific situation, and we propose to treat acute insomnia disorder through analytical-integrative cognitive behavioural therapy, formulate an individualized treatment plan to improve the therapeutic effect, and prevent the patient from developing in the direction of chronic insomnia.

Вмешательства

  • Поведенческое Analytic-Integrative Cognitive Behavioural Therapy
    Analytic-Integrative Cognitive-Behavioural Approach: Initial Interview for Information Gathering: comprehensive collection of patient information; Assessment: collection of multidimensional factors; Diagnosis: insomnia and co-morbidities; Analytic-Integrative Analysis for Treatment Decision Making.
  • Другое Sleep hygiene education
    Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.

Первичные конечные точки

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks. [Срок оценки: Baseline, 6 weeks]
Вторичные конечные точки (4)
  • The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]

Критерии участия

Критерии включения

  • meeting the DSM-5 diagnostic criteria for insomnia disorder;
  • a total score of >5 on the Pittsburgh Sleep Quality Index (PSQI);
  • age ≥18 years old, with junior high school education or above;
  • voluntarily participating in this study and signing an informed consent form;
  • the diagnostic criteria for acute insomnia disorder (duration of the disease less than 3 months).

Критерии исключения

  • people with comorbid serious physical or severe mental illnesses, suicide risk;
  • clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers;
  • pregnant and breastfeeding women;
  • people who are currently undergoing any psychological treatment.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06967922 · ICBT for AID

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗