NCT Number: NCT07167290
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.
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study completion, approximately 6 weeks
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 weeks
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 weeks
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 weeks
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: 1 month post-intervention follow up, approximately week 6
A qualitative interview conducted with participants to gain information regarding the acceptability of the intervention.
Contact information is provided by the study sponsor or research team.
Clarice Turton
CONTACT
David L Dawson
CONTACT
University of Lincoln
Other
SCI-FACT: The Acceptability and Effectiveness of Delivering a Focused Acceptance and Commitment Therapy Intervention in Inpatient Spinal Cord Injury Rehabilitation Settings
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