Brief Intervention for FCD: A Feasibility Study

Официальное название

Feasibility Pilot Study of a Brief Intervention in Functional Cognitive Disorder

Обзор

The goal of this study is to learn if a single session intervention for people with Functional Cognitive Disorder (FCD) is feasible and acceptable. The main questions it aims to answer are: What is the impact of a single session intervention on FCD symptoms, functional impairment, and quality of life in people with FCD? What is the feasibility and acceptability of piloting a single session intervention for people with FCD. Participants will: * Complete questionnaires about cognitive concerns, anxiety, depression, functional impairment and quality of life * Visit the clinic for a single session intervention including practicing the Attention Training Technique (ATT) * Complete 2 telephone calls with a researcher to discuss their use of the intervention and to complete the same questionnaires from their clinic visit, and a questionnaire about their experience of the study and intervention.

Вмешательства

• Поведенческое Brief psychological intervention including attention training
  Brief psychological intervention including attention training

Первичные конечные точки

• Participant recruitment, feasibility and retention from baseline to follow-up [Срок оценки: From enrollment to follow-up 6 weeks post-intervention.]

Вторичные конечные точки (6)

• Acceptability of the study intervention at follow-up [Срок оценки: Post-intervention follow-up at 6 weeks.]
• Change in symptoms of depression from enrolment to post-intervention follow-up [Срок оценки: At enrolment and at follow-up 6 weeks post-intervention]
• Change in symptoms of anxiety from enrolment to post-intervention follow-up [Срок оценки: At enrolment and at follow-up 6 weeks post-intervention]
• Change in functional impairment from enrolment to post-intervention follow-up [Срок оценки: At enrolment and at follow-up 6 weeks post-intervention]
• Change in quality of life from enrolment to post-intervention follow-up [Срок оценки: At enrolment and at follow-up 6 weeks post-intervention]
• Change in self-reported cognitive symptoms from enrolment to post-intervention follow-up [Срок оценки: At enrolment and at follow-up 6 weeks post-intervention]

Критерии участия

Критерии включения

• Adults aged 65 or below
• Meet criteria for diagnosis of FCD (criteria include normal MRI results with no neurological diagnosis, and symptoms that are not explained by any other medical condition, performance at routine pre-baseline neuropsychological assessment within the service)
• Not taking part in any other intervention study or trial

Критерии исключения

• Aged above 65 years
• Lack capacity to consent
• MRI results not in normal range
• Neurological diagnosis
• Indication of severe low mood or depression (from clinical interview, routine measures)
• Taking part in any other intervention study or trial

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

Великобритания · 1 центр

• King's College Hospital — London

Идентификаторы

NCT: NCT07379723 · IRAS Reference: 354504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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