An interventional study of Focused Acceptance and Commitment Therapy in Spinal Cord Injury, sponsored by University of Lincoln. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by University of Lincoln · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 8 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Lincoln is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
All participants will be in this arm and will receive a focused acceptance and commitment therapy intervention. This will be delivered over 1-3 sessions and be based on the facilitators handbook that will be provided to clinicians.
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.
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 weeks
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 weeks
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 weeks
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 weeks
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 6
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Jan 2026, 3 months later.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 3 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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