SCI-FACT: The Effectiveness of Focused ACT for SCI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Focused Acceptance and Commitment Therapy.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SCI-FACT: The Acceptability and Effectiveness of Delivering a Focused Acceptance and Commitment Therapy Intervention in Inpatient Spinal Cord Injury Rehabilitation Settings
Overview
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Recovering Quality of Life-10 (ReQol-10) [Time frame: Through study completion, approximately 6 weeks]
- Clinical Outcomes in Routine Evaluation 10 (CORE-10) [Time frame: through study completion, approximately 6 weeks]
- Appraisals of Disability Primary and Secondary Scale-Short Form (ADAPSS-sf) [Time frame: through study completion, approximately 6 weeks]
- Comprehensive assessment of Acceptance and Commitment Therapy Processes 10 (CompACT-10) [Time frame: Through study completion, approximately 6 weeks]
Secondary outcome measures (1)
- Feedback Interview [Time frame: 1 month post-intervention follow up, approximately week 6]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Those with a cognitive or physical impairment that would prevent their ability to engage with the intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07167290 · 25005