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Набор по приглашению NCT06591754

Feasibility, Acceptability, and Preliminary Effects of ISTDP for Personality Disorders in a Specialized Psychiatric Clinic

Без фазы С лечением Personality Disorder

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: ISTDP.
Кому может быть актуально
Состояния в реестре: Personality Disorder. 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
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Официальное название

A Pilotstudy Investigating Feasability, Acceptability and Preliminary Effects of ISTDP (Intensive Short Term Dynamic Psychotherapy) for Patients with Personality Disorder in a Psychiatric Clinic Specialized on Depression, Anxiety and PTSD

Обзор

The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. The secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.

Подробное описание

The investigators vill investigate a 25-week treatment with ISTDP that consists of both weekly group- and individual therapy for patients diagnosed with personality disorder in a psychiatric clinic specialized on depression, anxiety and PTSD. The feasibility and acceptability and preliminary effects will be evaluated using a within-group design with repeated measures and qualitative interviews. Patients will be recruited from the clinic and the main inclusion criteria is that the patient have a personality disorder diagnosis.

Вмешательства

  • Поведенческое ISTDP
    Both the individual therapy and the group therapy is based on ISTDP (Intensive Short-Term Dynamic Psychotherapy), an affect-focused psychodynamic therapy method. The therapy focus on the relationship between feelings, anxiety and dysfunctional emotion regulation (i.e. defenses). The purpose is to increase the capacity of anxiety regulation in the patient and to help the patient identify the dysfunctional patterns developed to avoid internal stress and then gradually approach previously warded of

Первичные конечные точки

  • Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews [Срок оценки: Immediately after treatment completion]
  • Depression symtoms [Срок оценки: Baseline, weekly throughout treatment, immediately after treatment completion and 6-month follow-up]
  • Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: Immediately after treatment completion (25 weeks)]
  • Adverse events related to the treatment [Срок оценки: From start of treatment up to. 6 month follow up.]
  • Number of individual sessions attended during the treatment [Срок оценки: Throughout the treatment period, up to 25 weeks]
  • Number of group sessions attended during the treatment [Срок оценки: Throughout the treatment period, up to 25 weeks]
  • Number of dropouts [Срок оценки: Throughout the treatment period, up to 25 weeks]
  • Total number of sessions attended during the treatment [Срок оценки: Throughout the treatment period, up to 25 weeks]
Вторичные конечные точки (10)
  • Fear of negative emotions [Срок оценки: Change from baseline to post-treatment (25 weeks) and follow up 6 months after treatment.]
  • Anxiety symtoms [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Emotions regulation difficulties [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Severity of personality disorder [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Symtoms of Borderline Personality disorder [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Severity of personality disorder [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Quality of life [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Quality of life [Срок оценки: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.]
  • Working alliance [Срок оценки: Weekly throughout treatment , up to 25 weeks]
  • Emotional activation during therapy [Срок оценки: Weekly throughout treatment, up to 25 weeks]

Критерии участия

Критерии включения

Personality disorder diagnosis (Clinical assessment using STIP-5) Speaks Swedish fluently

Критерии исключения

Autism or intellectual disability Borderline, antisocial or narcissistic personality disorder diagnosis Need for interpreter Urgent social misery Psychotic disorder High suicidality

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

Швеция · 1 центр
  • Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst — Stockholm

Идентификаторы

NCT: NCT06591754 · 2024-04361-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗