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Идёт набор NCT07362511

Imagery Rescripting in Primary Care

Без фазы С лечением Major Depressive Diorder Low Self-Esteem Mood Disorders

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: Imagery Rescripting.
Кому может быть актуально
Состояния в реестре: Major Depressive Diorder, Low Self-Esteem, Mood Disorders. Базовые параметры: 18 лет — 70 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
Нидерланды
Следующий шаг
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Официальное название

Imagery Rescripting Within Primary Care to Manage Depression: A Single-Case Experimental Design

Обзор

In the current study we aim to investigate the feasibility, acceptability, and effectiveness of ImRs offered by mental health assistants within primary care to reduce depressive symptoms. In a single-case experimental design (SCED) study, the following hypotheses will be tested: 1. ImRs results in a reduction of depressive symptoms compared to baseline, and this reduction lasts up to six months. 2. Patients with complaints of depressive symptoms find ImRs an acceptable form of intervention when offered by mental health assistants within a general practice setting. Participants will wait for 2-4 weeks and then receive 5 sessions of ImRs over a period of 10 weeks. During these sessions, negative memories related to their depressed feelings are rescripted.

Подробное описание

The study consists of a multiple-baseline case series in which the effectiveness and feasibility of Imagery Rescripting as a therapeutic technique will be investigated within primary care, with the aim of reducing depressive symptoms. The intervention will be provided by the mental health assistants (POH-GGZ) at the GP practice that is linked to the University of Amsterdam (Huisartsenpraktijk UvA). These mental health assistant have been trained in Imagery Rescripting. In the study, participants are randomly assigned to a baseline condition of 2-4 weeks, and a subsequent intervention condition of 10 weeks. During the intervention, all patients receive five sessions of Imagery Rescripting (45 minutes per session). Throughout these 12-14 weeks, and for 4 weeks after, participants complete bi-weekly (i.e., twice per week) measurements. The total number of bi-weekly measurements is thus 32-36, depending on the baseline condition that participants are randomized to. In addition, there will be 5 longer questionnaires, including a 3 and 6-month follow-up. Participants that are invited to the study but that do not want to participate will receive care as usual by the mental health assistant.

Вмешательства

  • Поведенческое Imagery Rescripting
    During ImRs, the patient brings a negative memory to mind and changes, together with the therapist, the outcome of the memory into a more positive

Первичные конечные точки

  • Depressive symptom severity [Срок оценки: 16-18 weeks, twice a week]
  • Self-esteem [Срок оценки: 16-18 weeks, twice a week]
  • Dysfunctional core beliefs [Срок оценки: 16-18 weeks, twice a week + 3 month and 6 month follow-up]
Вторичные конечные точки (4)
  • Hospital Anxiety and Depression Scale [Срок оценки: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up]
  • Rosenberg Self-Esteem Scale [Срок оценки: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up]
  • Suicidal thoughts [Срок оценки: Baseline, pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up]
  • Emotional memory [Срок оценки: Pre-treatment, 4-weeks post-treatment, 3 month follow-up, 6 month follow-up]

Критерии участия

Критерии включения

  • Main complaint of depressive feelings, as indicated by both the mental health assistant and the patient.
  • HADS score for the depression subscale ≥ 11.
  • Ability to understand, read, write and speak Dutch or English.
  • Age between 18 and 70.
  • Willingness to participate in the study and treatment.

Критерии исключения

  • Acute suicide risk (BDI-II-item9 score of 3).
  • If the mental health assistant suspects that the patient may have a primary diagnosis of bipolar disorder, psychosis, substance use disorder, low IQ, or if the patient suffers from serious neurological problems such as dementia, then the patient is not included. There will not be a formal assessment of a primary diagnosis.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • UvA Huisartsen — Amsterdam

Идентификаторы

NCT: NCT07362511 · FMG-11030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗