SCI-FACT: The Effectiveness of Focused ACT for SCI Patients

Официальное название

SCI-FACT: The Acceptability and Effectiveness of Delivering a Focused Acceptance and Commitment Therapy Intervention in Inpatient Spinal Cord Injury Rehabilitation Settings

Обзор

Research has found that patients with a Spinal Cord Injury (SCI) suffer with longstanding mental health difficulties, likely due to the impact of the lifelong physical and health problems that come with their injury. Therefore, it is important to make sure that there is effective psychological support available to them. Unfortunately, research shows that the most commonly used therapy approach, CBT, has very inconsistent evidence regarding its effectiveness for SCI patients. It has also been found that providing support shortly after the injury can be helpful for patients in the long term. Therefore, this study aims to evaluate whether an alternative therapy approach, called Focused Acceptance and Commitment Therapy (FACT), can be effectively delivered to SCI patients shortly after their injury, whilst they are recovering in hospital. To answer this question, a single case experimental design (SCED) series will be used in which participants will regularly complete a number of questionnaires asking about: symptoms relating to their mental health; quality of life; how they are adjusting to their injury; and how they approach coping with difficulties they face, before receiving FACT and for a period of time afterwards. This will provide quantitative information regarding the effect of the intervention. At a one month follow up, these questionnaires will be repeated, and participants will be interviewed about their experiences of the intervention to understand whether there are any issues that need to be considered when using this therapy for SCI patients in hospitals. Using a SCED series design will require us to recruit at least 3 participants. The information will be analysed to conclude whether it is feasible to use this therapy in this way, and whether it is effective at improving the mental health and quality of life of SCI patients.

Вмешательства

• Поведенческое Focused Acceptance and Commitment Therapy
  Focused Acceptance and Commitment Therapy will be delivered following a facilitators guide. The intervention is adapted for Spinal Cord Injury patients and is to be delivered on an inpatient neurorehabilitation setting over the course of 1-3 sessions.

Первичные конечные точки

• Recovering Quality of Life-10 (ReQol-10) [Срок оценки: Through study completion, approximately 6 weeks]
• Clinical Outcomes in Routine Evaluation 10 (CORE-10) [Срок оценки: through study completion, approximately 6 weeks]
• Appraisals of Disability Primary and Secondary Scale-Short Form (ADAPSS-sf) [Срок оценки: through study completion, approximately 6 weeks]
• Comprehensive assessment of Acceptance and Commitment Therapy Processes 10 (CompACT-10) [Срок оценки: Through study completion, approximately 6 weeks]

Вторичные конечные точки (1)

• Feedback Interview [Срок оценки: 1 month post-intervention follow up, approximately week 6]

Критерии участия

Критерии включения

• Have a diagnosis of a Spinal Cord Injury (SCI)
• Be an inpatient receiving MDT rehabilitation for SCI
• Be able to understand and communicate in English sufficiently to allow for engagement with the intervention, including with the use of reasonable adjustment such as an interpreter, as provided by their usual care team
• Have access to an internet enabled device

Критерии исключения

• Those with a cognitive or physical impairment that would prevent their ability to engage with the intervention

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07167290 · 25005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗