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Идёт набор NCT05731414

Outcomes From Remediation and Behavioural Intervention Techniques

Без фазы С лечением Schizophrenia Psychosis Psychotic Disorders Schizophrenia; Psychosis

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 Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR), Befriending, Sham Cognitive Remediation.
Кому может быть актуально
Состояния в реестре: Schizophrenia, Psychosis, Psychotic Disorders, Schizophrenia; Psychosis. Базовые параметры: 18 лет — 65 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders

Обзор

It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.

Подробное описание

Dominant treatment approaches for schizophrenia-spectrum disorders improve psychiatric symptoms but do little to improve community functioning, leading to persistent disability and substantial economic burden. The proposed trial aims to examine the efficacy of a multi-mechanism approach to combining CBT and CR with the goal of predicting treatment response to either monotherapy or combination therapy. To date, there have been no randomized controlled trials examining the combination of CBT and CR. Given the differential mechanisms of CBT and CR, the combined multi-mechanism approach is expected to more effectively improve functional recovery than either monotherapy. Additionally, it is currently unknown what factors predict response to CBT or CR, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy. The proposed trial will be one of the largest trials of psychosocial interventions for schizophrenia-spectrum disorders ever conducted and will simultaneously evaluate the combined intervention and moderators of differential treatment response. Narrower fields of inquiry examining mono-mechanism interventions have demonstrated little utility in improving functional recovery in schizophrenia, thus, the proposed approach represents a critical advancement by examining the utility of a multi-mechanism cognitive intervention and determining characteristics of those requiring this level of treatment.

The goals of the current study are three-fold:

1. Examine the efficacy of combining CBT and CR on the primary outcome of community functioning, and secondary outcomes of quality of life, personal recovery, psychiatric symptoms, and neurocognition compared to either intervention alone. 2. Examine demographic, cognitive, and psychological factors that predict differential response to CBT, CR, or combined CBT and CR. 3. Examine the specificity of cognitive content and cognitive functions as therapeutic mechanisms in CBT and CR respectively.

Вмешательства

  • Поведенческое Cognitive Behavioural Therapy for Psychosis (CBTp)
    Individual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness. This approach has demonstrated moderate to large improvements on symptoms and small to moderate effects on functioning. The first four sessions are devoted to building therapeutic rapport and developing collaborative treatment goals. The following phase focuses on developing formulations of why
  • Поведенческое Cognitive Remediation Therapy (CR)
    Action-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials. ABCR involves practicing computerized training exercises with difficulty level dynamically titrated to improve neurocognitive abilities. Then participants engage in strategy discussions with other group members to develop new cognitive strategies. Finall
  • Поведенческое Befriending
    Befriending will be delivered according to a manual validated to control for the non-specific effects of CBT, such as duration of therapeutic contact, client expectancy effects, therapeutic alliance, and therapist warmth. Befriending consists of 1-hour individual sessions once per week and involves a series of conversations similar to those one might have with a social acquaintance. These conversations involve discussion of neutral topics without problem-solving, coping strategies, or exploratio
  • Поведенческое Sham Cognitive Remediation
    Sham CR was developed by Dr. Best and Dr. Bowie (CI) to control for the non-specific effects of CR such as computer practice and group discussion. Participants practice similar computerized exercises to ABCR, however, the exercises do not increase in difficulty. Participants then discuss enjoyment of the exercises but any discussion of cognitive strategies is redirected back to a neutral topic. We have previously found this condition to be an effective control for CR, with similar engagement to

Первичные конечные точки

  • Social Functioning Scale (SFS) [Срок оценки: Change between baseline assessment and 18-month assessment]
Вторичные конечные точки (12)
  • World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Questionnaire About the Process of Recovery (QPR) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Psychotic Symptom Rating Scale (PSYRATS) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Neurocognitive Assessment [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Beliefs About Paranoia Scale (BAPS) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Interpretations of Voices Inventory (IVI) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Brief Core Schema Scale (BCSS) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) [Срок оценки: Change between baseline assessment and 18-month assessment]
  • Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS) [Срок оценки: Change between baseline assessment and 18 month assessment]

Критерии участия

Критерии включения

  • Aged 18-65 years
  • Diagnosed with schizophrenia-spectrum disorders
  • Can read, write, and speak English

Критерии исключения

  • Neurodevelopmental disability or neurocognitive disorder
  • CBT or CR in the past 6 months

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Канада · 2 центра
  • University of Toronto Scarborough — Scarborough Village
  • Ontario Shores Centre for Mental Health Sciences (Ontario Shores) — Whitby

Идентификаторы

NCT: NCT05731414 · 43817

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗