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Набор скоро начнётся NCT06866639

Cognitive Behavioural Therapy/Metacognitive Therapy for Low Self Esteem

Без фазы С лечением Psychological 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: Cognitive behavioral therapy, Metacognitive therapy.
Кому может быть актуально
Состояния в реестре: Psychological Disorders. 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
Норвегия
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 goal for this clinical trial is to explore the effect of CBT/MCT on the treatment of low self esteem. 20 patients with low self-esteem will be selected and distributed into two either MCT or a CBT We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.

Подробное описание

The association between low self-esteem and psychiatric disorders indicates that low self-esteem is an important transdiagnostic construct. People who report having a low self-esteem seem to experience more mental health problems and a reduction in quality of life.

There have been a few trials considering the effect of Cognitive Behavioural Therapy (CBT) for low self-esteem, however, there are few randomized controlled studies. Recently, Meta Cognitive Therapy (MCT) has been introduced as a new, specific treatment for MDD, showing promising and lasting results. This treatment approach also has proven more effective than CBT for GAD or worry disorder. So far, no study has examined MCT for low self-esteem in a randomized controlled trial.

For the present clinical trial, 20 patients with low self-esteem will be selected and distributed into two treatment conditions. The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT. The patients will be assessed with different outcome measures at pre-treatment, at the end of treatment, and at six months follow up. In addition, they will also be assessed weekly using various measures.

We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.

Вмешательства

  • Поведенческое Cognitive behavioral therapy
    The CBT is based on the treatment manual written by Fennell (1997). The patients receiving CBT will be treated for 8 sessions, with weekly session of 45-60 minutes duration.
  • Поведенческое Metacognitive therapy
    The meta-cognitive treatment program is based on Wells's metacognitive therapy (Wells, 2013). The patients receiving meta-cognitive therapy will be treated for 8 sessions, with weekly session of 45-60 minutes duration.

Первичные конечные точки

  • Rosenberg Self Esteem Scale [Срок оценки: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks), and six months follow up]
Вторичные конечные точки (2)
  • GAD-7 [Срок оценки: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks, post-treatment (8 weeks) and six months follow up]
  • PHQ-9 [Срок оценки: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks) and six months follow up]

Критерии участия

Критерии включения

  • Signed written informed consent obtained prior to entry in the study.
  • Scores below 15 on the Rosenberg Self-esteem Scale (RSE)
  • 18 years or older.

Критерии исключения

  • Psychosis
  • Bipolar type 1
  • Current suicide intent
  • PTSD
  • Cluster A or cluster B personality disorder
  • Substance dependence

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • Department of Psychology, University of Oslo — Oslo

Идентификаторы

NCT: NCT06866639 · LSE06064685

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗