Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)
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: Cognitive Behavioural Therapy (CBT), Ecological Momentary Assessment (EMA).
- 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The effects of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression are assessed in this randomised trial. Monitoring consists of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA are compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). 84 patients with mild to moderate depression will be randomised to CBT + EMA or to TAU.
Подробное описание
As mobile technologies advance, healthcare is increasingly utilising mobile interventions to accompany traditional interventions such as psychotherapy. Mobile assessments of symptoms and other processes are also used as low-level interventions and are believed to lead to symptom improvements in patients with symptoms of depression, for example. However, robust evidence on the health benefits of monitoring interventions in patients with depression is lacking.
The investigators are interested in the potential benefits of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression. Therefore, the investigators will conduct a randomised trial to investigate the effects of a monitoring intervention consisting of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA will be compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). Participants in the CBT + EMA group will be asked to answer monitoring questions twice daily for two four-week blocks during the CBT treatment. A total of 84 participants with mild to moderate depression will be randomized. Of these, 48 participants will be randomized to CBT + EMA and 36 participants will be randomized to TAU. The primary outcome of interest is change in the Patient Health Questionnaire (PHQ-9) score at four-month follow-up assessment.
Throughout the study, there will be five assessment timepoints: Baseline (before the first therapy session), four weeks after the fourth therapy session, four weeks after the twelfth therapy session, after the last session (post-treatment) and the 4-month follow-up (four months after the last therapy session).
Вмешательства
- Поведенческое Cognitive Behavioural Therapy (CBT)
20 sessions of face-to-face, individual CBT - Другое Ecological Momentary Assessment (EMA)
Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes
Первичные конечные точки
- Patient Health Questionnaire (PHQ-9) [Срок оценки: 4-month follow-up]
Вторичные конечные точки (12)
- Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Beck's Depression Inventory (BDI-II) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Certainty About Mental States Questionnaire (CAMSQ) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Dysfunctional Attitude Scale (DAS-18A) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Depression-Specific Self-Efficacy Expectation Questionnaire (DSWE) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Evaluation of Treatment Progress Questionnaire (FEP-2) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Level of Personality Functioning Scale - Brief Form (LPFS-BF 2.0) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Positive and Negative Affect Schedule (PANAS) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Personality Inventory for DSM-5 - Brief Form Plus (PID-5-BF+ M) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Health Survey - Short Form (SF-8) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Symptoms Checklist (SCL-K-9) [Срок оценки: Baseline, 4 weeks after the 4th session, 4 weeks after the 12th session, immediately after the last session and the 4-month follow-up]
- Treatment Satisfaction Questionnaire (ZUF-8) [Срок оценки: Immediately after the last session]
Критерии участия
Критерии включения
- ICD-10 diagnosis of mild or moderate depression, first or recurrent episode (F32.0, F32.1, F33.0, F33.1)
- PHQ-9 ≥ 5
- Possession of smartphone with internet access
- Signed informed consent
Критерии исключения
- Acute or past suicidality; self-reported
- Acute addiction (F10 - F19)
- Dysthymia (F34.1), postpartum depression, or severe depression (F32.3; F33.3)
- PHQ-9 > 20
- Depression not main mental health concern
- Planned onset or planned change in antidepressant medication
- History of psychotic symptoms, bipolar disorder, personality disorders, or organic brain disorders
- Cognitive impairment or physical disability that would hinder psychotherapy or the use of a smartphone
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
Швейцария · 1 центр
- Psychotherapeutisches Zentrum Universität Zürich — Zurich
Идентификаторы
NCT: NCT05553197 · 10001C_200760