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Набор скоро начнётся NCT06665321

Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial

Без фазы С лечением Trait Neuroticism

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: Internet-based psychodynamic therapy (IPDT).
Кому может быть актуально
Состояния в реестре: Trait Neuroticism. 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of the study is to investigate if internet delivered affect-focused psychodynamic therapy (IPDT) leads to lowered levels of trait neuroticism compared to a wait-list control condition. The target group is adults (18+) who experience mild to moderate symptoms of anxiety and/or depression. The IPDT treatment consists of 8 modules that the participants will work with for 9 weeks, with therapist support. Participants will be recruited in Sweden with nationwide recruitment.

Подробное описание

This study is a randomized controlled trial with the aim to investigate if IPDT leads to lowered levels of trait neuroticism. Participants will either be randomized to the treatment which is based on Affect Phobia Therapy or to a wait-list control. Participants will have weekly contact with a therapist who will provide feedback and support.

Primary outcome measure is trait neuroticism (measured on the 24-Item Neuroticism scale of the IPIP-NEO-120). Secondary outcome measures will include measures of anxiety, depression, quality of life, emotion regulation, and defense mechanism adaptiveness. Emotion regulation and short measure of anxiety and depressive symptoms will be collected weekly throughout the treatment period. Pre-treatment measurement, post-treatment measurement, weekly measure, and one-year follow up is planned to be collected through an online survey.

Вмешательства

  • Поведенческое Internet-based psychodynamic therapy (IPDT)
    The intervention is 9 week long with weekly modules that the participants work with while receiving weekly support from an assigned therapist.

Первичные конечные точки

  • Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
Вторичные конечные точки (7)
  • Eysenck Personality Questionnaire Revised - Shortform (EPQR-S) [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Patient Health Questionnaire-9 [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Generalized Anxiety Disorder-7 [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Brunnsviken Brief Quality of life scale [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Difficulties in Emotion Regulation Scale-16 [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination. Will be measured on a weekly basis during the 9 weeks of the intervention period.]
  • Defense Mechanism Rating Scale - Self Report 30 [Срок оценки: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Patient Health Questionnaire - 4 [Срок оценки: Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.]

Критерии участия

Критерии включения

  • Score 5 points or more on either the PHQ-9 or GAD-7
  • 18 years or older
  • Ability to speak, read and write in Swedish
  • Have access to the internet and a smartphone, computer or other device

Критерии исключения

  • Severe psychiatric or somatic illness that makes participation difficult or impossible
  • Ongoing addiction
  • Acute suicidality
  • Other ongoing psychological treatment
  • Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks

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

Швеция · 1 центр
  • Department of Behavioral Sciences and Learning — Linköping

Идентификаторы

NCT: NCT06665321 · LINNEA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗