NCT07170969

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 21, 2026

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

September 4, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

spinal cord injuriesfeasibility and acceptabilitymental healthParticipation in meaningful activitiesspinal cord injury

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

EXPERIMENTAL

The 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.

Other: An Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury

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

A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwell

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Spinal Cord InjuriesPsychological Well-Being

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPersonal SatisfactionBehavior

Study Officials

  • Yan Li, Dr

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

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
Model Details: We aim to have a single study group, which the group will receive eight weekly online group sessions (6-8 participants per group) with one hour for each session using Zoom videoconferencing software.
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

Locations