Is Less More? Dosing and Sequencing Effect
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 restructuring, Attention allocation.
- Кому может быть актуально
- Состояния в реестре: Depression/Anxiety. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Is Less More? Dosing and Sequencing Effects of Cognitive Therapies for Anxiety and Depression
Обзор
The investigators want to evaluate core components from cognitive behavioral psychotherapies (CBTs) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression.
Подробное описание
In the present study, participants will be randomly assigned to one of four groups, receiving one or both treatment components under investigation, all over the course of six sessions of treatment.
1. It is hypothesized that both component A (Cognitive Restructuring) and component B (External Attention Allocation) will be efficient in reducing symptoms of depression and anxiety when delivered separately, both when delivered over 3 and 6 sessions. The difference between components as well as between the number of sessions on primary and secondary outcomes will be explored. 2. The combinatory effects, comparing the effect of receiving Component A subsequent to Component B and vice versa will be explored. 3. The process of change in both components will be explored. 4. Group differences in participants' experience of being the recipient of the components (either individually or combination) both qualitatively (free descriptions of their experience with using them) and quantitatively (questionnaires concerning the understanding and employment) will be explored. 5. The moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored. 6. Potential harmful effects will be explored in each group.
Вмешательства
- Поведенческое Cognitive restructuring
CR drawn from classic CBT - Поведенческое Attention allocation
AA drawn from contemporary CBTs
Первичные конечные точки
- Depressive symptoms [Срок оценки: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.]
- Anxiety symptoms [Срок оценки: Change from pre (just prior to session 1) to post treatment (after session 6), app. 7 weeks in total.]
Вторичные конечные точки (12)
- Depressive symptoms [Срок оценки: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.]
- Anxiety symptoms [Срок оценки: Change from pre treatment (just prior to session 1) through follow-up (6 months after treatment has ended), app. 33 weeks in total.]
- Symptoms of generalized anxiety disorder [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.]
- Symptoms of panic disorder [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.]
- Symptoms of social anxiety disorder [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment has ended) only for those individuals that scores above cut-off during the screening process, app. 33 weeks in total.]
- Worry [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
- Decentering [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
- Cognitive change [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
- Cognitive reappraisal [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
- Mindfulness [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
- Attention control [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
- Valued Living [Срок оценки: Changes from pre (just prior to session 1) to post treatment (just after session 6) and through follow-up (6 months after treatment ended), app. 33 weeks in total.]
Критерии участия
Критерии включения
(i) age ≥ 18 years, (ii) Clinically relevant symptoms of an anxiety disorder (with the exception of specific phobia) and/or depressive disorder according to GAD-7≥10, SIAS ≥37, PHQ-9 ≥10, or PDSS ≥9, (iii) Danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with video camera.
Критерии исключения
(i) severe depression deemed to require more intense psychotherapy or medication (PHQ-9-score of 20 or more combined with a clinical evaluation), (ii) currently receiving other psychotherapy or counseling, (iii) a history of bipolar disorder, (iv) current or past psychotic episode, (v) substance abuse or dependence judged to require treatment, (vi) suicide risk requiring immediate hospitalization.
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06920888 · 4282-00031B