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

NCT07167290 | Not Yet Recruiting

• 1 other identifier: 25005
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Acceptance and Commitment Therapy; Brief Intervention

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  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

  Through study completion, approximately 6 weeks

Secondary Outcomes (1)

• Feedback Interview

  1 month post-intervention follow up, approximately week 6

Study Arms (1)

Focused Acceptance and Commitment Therapy

EXPERIMENTAL

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

Interventions

Focused Acceptance and Commitment Therapy BEHAVIORAL

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.

Focused Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lincoln: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David L Dawson

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarice Turton

CONTACT

01522 886029; 28642448@students.lincoln.ac.uk

David L Dawson

CONTACT

01522 886029; ddawson@lincoln.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single case experimental design (SCED) series will be used.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share