A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme for Community-dwelling People With Spinal Cord Injury

NCT ID: NCT07170969

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-09-30

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.

Detailed Description

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.

The intervention group: The E-COSP intervention includes four major components: (1) orientation and encouragement (one session); (2) cognitive appraisal (one session); (3) coping strategies (four sessions); and (4) social support and future (two sessions). The E-COSP intervention was modified from the original COSP programme. The modifications include 1) Incorporating common stressful situations or scenarios that participants may encounter in community or home settings (e.g., overcoming transportation barriers, managing social relationships with family and friends, and enhancing social participation; 2) strengthening the training content to further enhance participants' self-efficacy (e.g., effective goal setting, positive self-talk, and practical advice for skills development).

Delivery of the E-COSP intervention. 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 outcomes: Feasibility and acceptability: The feasibility will be assessed by recruitment rate, retention rate, drop-out rate; and the acceptability will be assessed by adherence rate and participants' satisfaction.

Secondary outcomes Mental health. The 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess the mental health (depression and anxiety) of the participants. The HADS comprises two subscales (each with 7 items) to assess participants' depression and anxiety levels. Responses will be given on a 0 to 3 Likert scale. Higher scores indicate more distress. Scores between 8-15 are considered mild to moderate cases, and 16 or above are severe cases. Both the Chinese and English versions of HADS have demonstrated good psychometric properties (Cronbach's alpha = 0.72-0.82) among the spinal cord injury population.

Participation in meaningful activities. The Chinese version of the Meaningful Activity Participation Assessment will be adopted. This is a checklist survey with two subscales: Frequency Subscale measures how often each activity was engaged in over the past few months on a scale from 0 (not at all) to 6 (every day); Meaningfulness Subscale assesses the perceived meaningfulness of each activity on a scale from 0 (not at all meaningful) to 4 (extremely meaningful). Scores for each item are calculated by multiplying the frequency and meaningfulness ratings, resulting in a total score ranging from 0 to 672, where higher scores indicate greater meaningful activity participation. The scale has demonstrated good psychometric properties (Cronbach's alpha = 0.86). Quality of life. The EuroQoL 5 Dimension will be adopted. This scale includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels, from no problems to extreme problems. The scale has been used in the SCI population, and it has demonstrated good psychometric properties among people with physical disabilities (Cronbach's alpha = 0.78). Coping strategies. The 28-item Coping Orientation to Problems Experienced Inventory will be used to evaluate coping strategies. This scale measures two conceptually distinct patterns of coping behaviours: maladaptive coping and adaptive coping. The score of each item ranged from 1 ('I usually do not do this at all') to 4 ('I usually do this often'). Higher scores indicated the more frequent use of the corresponding strategy. The Chinese version of this scale has demonstrated good psychometric properties (Cronbach's alpha = 0.85). Self-efficacy. The Chinese version of the Moorong Self-Efficacy Scale will be used to measure self-efficacy. It employs a seven-point Likert scale including 16 items, and the score of each item ranges from 1 to 7, with 1 indicating "very uncertain" and 7 indicating "very certain". The total score ranged from 16 to 112, with a higher score indicating more self-efficacy. This scale has demonstrated good validity among Chinese patients with SCI (Cronbach's α = 0.89).

Conditions

Spinal Cord Injury; Mental Health; Feasibility Studies; Acceptability Study; Spinal Cord Injuries (SCI); Spinal Cord Injuries; Coping

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Li, Dr

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

School of Nursing, The Hong Kong Polytechnic University, Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

PolyuSNLIYAN

Identifier Type: -

Identifier Source: org_study_id