SCI-FACT: The Effectiveness of Focused ACT for SCI Patients
ConditionSpinal Cord Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Lincoln
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Those with a cognitive or physical impairment that would prevent their ability to engage with the intervention
Trial design
Design model
Single group
Treatments tested in this trial
Focused Acceptance and Commitment Therapy
BehavioralFocused 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.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Focused Acceptance and Commitment TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recovering Quality of Life-10 (ReQol-10)
A measure quality of life (scores range 0 (poor quality of life) - 40 (high quality of life)). Assessed at least three time throughout baseline phase (minimum of one week), at least three times following intervention (minimum of one week) and again at a one month post-intervention follow up
Time frame
Through study completion, approximately 6 weeks2
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
A measure of psychological distress. Scores range from 0 (no/low psychological distress) to 40 (severe psychological distress). To be assessed once at baseline, once following the completion of the intervention and once at a one month post-intervention follow up.
Time frame
through study completion, approximately 6 weeks3
Appraisals of Disability Primary and Secondary Scale-Short Form (ADAPSS-sf)
A measure to assess cognitive appraisals of, and adjustment to, disability. Scores range from 0-36 with higher scores indicating poorer adjustment. Assessed at least three time throughout baseline phase (minimum of one week), at least three times following intervention (minimum of one week) and again at a one month post-intervention follow up
Time frame
through study completion, approximately 6 weeks4
Comprehensive assessment of Acceptance and Commitment Therapy Processes 10 (CompACT-10)
A measure of Psychological flexibility, the core process underlying Acceptance and Commitment Therapy. Higher scores indicate greater psychological flexibility. Assessed at least three time throughout baseline phase (minimum of one week), at least three times following intervention (minimum of one week) and again at a one month post-intervention follow up
Time frame
Through study completion, approximately 6 weeksSecondary outcomes
1
Feedback Interview
A qualitative interview conducted with participants to gain information regarding the acceptability of the intervention.
Time frame
1 month post-intervention follow up, approximately week 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: