Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT07170969
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-24
First Post:
2025-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme for Community-dwelling People With Spinal Cord Injury
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People With Spinal Cord Injury
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: