A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme for Community-dwelling People With Spinal Cord Injury
1 other identifier
interventional
12
1 country
1
Brief Summary
Spinal cord injury (SCI) is a neurological disorder that leads to "partial or complete loss of people's motor and/ or sensory function below the level of the injury". This study is a single-group feasibility trial with pre- and post-assessment. The total sample size is 12. This is a feasibility trial of an Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury. Twelve SCI participants will be recruited from the Hong Kong Direction Association for the Handicapped. The intervention group will receive eight weekly online group sessions (6-8 participants per group) with one hour for each session using Zoom videoconferencing software. A detailed intervention manual will be used to guide all intervention delivery. The intervention will be led by a registered rehabilitation nurse (who will be employed as a part-time RA2) who has more than three years of work experience in caring for people with SCI. The nurse who delivers the intervention will receive extensive training from the PI and CI, who are experts in coping interventions and relevant psychosocial intervention skills. The intervention providers will also receive training in group dynamics and group intervention skills, and be supervised by the research team and a psychologist during the whole period of the study. Selected audio-taped intervention sessions will be rated by the PI and CI on the fidelity of the intervention delivery. Primary outcome will be the feasibility and acceptability: The feasibility will be assessed by recruitment rate, retention rate, and drop-out rate; and the acceptability will be assessed by adherence rate and participants' satisfaction. And the secondary outcomes will be mental health, Quality of Life, participation in meaningful activities, coping strategies, and self-efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2025
CompletedFirst Submitted
Initial submission to the registry
September 4, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJanuary 21, 2026
August 1, 2025
3 months
September 4, 2025
January 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of the programme
The feasibility of the programme will be assessed by recruitment rate, retention rate, and drop-out rate.
Feasibility will be assessed during the post-intervention, an average of 8 weeks.
Acceptability of the programme
The acceptability of the programme will be assessed by adherence rate and participants' satisfaction.
Acceptability will be assessed during the post-intervention, an average of 8 weeks.
Secondary Outcomes (10)
Mental health at pre-intervention
Mental health will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.
Mental health at post intervention
Mental health will be assessed at post-intervention, an average of 8 weeks.
Participation in meaningful activities at pre-intervention
Participation in meaningful activities will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.
Participation in meaningful activities at post-intervention
Participation in meaningful activities will be assessed at post-intervention, an average of 8 weeks.
Quality of life at pre-intervention
Quality of life will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.
- +5 more secondary outcomes
Study Arms (1)
A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwell
EXPERIMENTALThe E-COSP intervention, modified from the original COSP, consists of eight weekly online group sessions via Zoom. Its four components-orientation, cognitive appraisal, coping strategies (4 sessions), and social support (2 sessions)-are enhanced with realistic community scenarios and strengthened self-efficacy training. A trained rehab nurse with over three years of SCI experience will deliver the manualized intervention. The nurse will receive extensive training and ongoing supervision from experts and a psychologist. Intervention fidelity will be ensured through audio-taped session reviews by the principal investigators.
Interventions
The intervention group will receive eight weekly online group sessions (6-8 participants per group) with one hour for each session using Zoom videoconferencing software. A detailed intervention manual will be used to guide all intervention delivery. The intervention will be led by a registered rehabilitation nurse (who will be employed as a part-time RA2) who has more than three years of work experience in caring for people with SCI. The nurse who delivers the intervention will receive extensive training from the PI and CI, who are experts in coping interventions and relevant psychosocial intervention skills. The intervention providers will also receive training in group dynamics and group intervention skills, and be supervised by the research team and a psychologist during the whole period of the study. Selected audio-taped intervention sessions will be rated by the PI and CI on the fidelity of the intervention delivery
Eligibility Criteria
You may qualify if:
- Hong Kong residents aged 18 -65 years old
- individuals currently living in the community with a diagnosis of SCI for at least 6 months, and who are currently having stable medical conditions
- experiencing mild to moderate depression or anxiety (scores of between 8-15 as assessed by the Hospital Anxiety and Depression Score for either the Depression or Anxiety Subscales)
- able to access and use an internet-enabled device (e.g., computer, tablet, smartphone) for attending online meetings
- able to speak/understand Cantonese/Traditional Chinese.
You may not qualify if:
- currently receiving any psychosocial interventions (e.g., coping skills training, cognitive behavioral therapy, or mindfulness training)
- present with any significant cognitive impairment (with reference to the clinical record), brain injury, or medical instability (with unstable cardiopulmonary diseases, pressure ulcers, contracture or marked muscle hypertonicity)
- have problems with hearing, verbal communication, and vision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Nursing, The Hong Kong Polytechnic University, Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Li, Dr
School of Nursing, The Hong Kong Polytechnic University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- There is only one study group, and the trial will estimate the feasibility and acceptability of the E-COSP during the pre and post intervention. Therefore, all participants and investigators not necessary to be blinded due to the nature of this trial.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2025
First Posted
September 12, 2025
Study Start
July 15, 2025
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
January 21, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share