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Spinal Cord InjuryNCT07170969

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

A study testing An Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury in people with Spinal Cord Injury and Mental Health, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
An Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteHong Kong
Study dates
15 Jul 2025to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • School of Nursing, The Hong Kong Polytechnic University, Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People With Spinal Cord Injury

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.

Read more

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.

Read the 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).

Being tested
An Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury
Keywords
spinal cord injuries, feasibility and acceptability, mental health, Participation in meaningful activities, spinal cord injury
Medical subject headings
Spinal Cord Injuries, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

Study groups in NCT07170969
Study groupRoleWhat they receive
A Feasibility Trial of an Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-DwellExperimentalThe 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.
Receives: Other: An Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the programme

    The feasibility of the programme will be assessed by recruitment rate, retention rate, and drop-out rate.

    Measured: Feasibility will be assessed during the post-intervention, an average of 8 weeks.

  2. Acceptability of the programme

    The acceptability of the programme will be assessed by adherence rate and participants' satisfaction.

    Measured: Acceptability will be assessed during the post-intervention, an average of 8 weeks.

Secondary outcomes (10)
  1. Mental health at pre-intervention

    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.

    Measured: Mental health will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.

  2. Mental health at post intervention

    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.

    Measured: Mental health will be assessed at post-intervention, an average of 8 weeks.

  3. Participation in meaningful activities at pre-intervention

    The Chinese version of the Meaningful Activity Participation Assessment will be adopted [40]. 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.

    Measured: Participation in meaningful activities will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.

  4. Participation in meaningful activities at post-intervention

    The Chinese version of the Meaningful Activity Participation Assessment will be adopted [40]. 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.

    Measured: Participation in meaningful activities will be assessed at post-intervention, an average of 8 weeks.

  5. Quality of life at pre-intervention

    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).

    Measured: Quality of life will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.

  6. Quality of life at post-intervention

    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).

    Measured: Quality of life will be assessed at post-intervention, an average of 8 weeks.

  7. Coping strategies at pre-intervention

    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.

    Measured: Coping strategies will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.

  8. Coping strategies at post-intervention

    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.

    Measured: Coping strategies will be assessed at post-intervention, an average of 8 weeks.

  9. Self-efficacy at pre-intervention

    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.

    Measured: Self-efficacy will be assessed at pre-intervention, at the beginning of the study, before 8 weeks start.

  10. Self-efficacy at post-intervention

    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.

    Measured: Self-efficacy will be assessed at post-intervention, an average of 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2025
  2. Study start15 Jul 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07170969
Sponsor's protocol ID
PolyuSNLIYAN
Status last verified
Aug 2025
First submitted
4 Sep 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing An Enhanced Coping-oriented Supportive Programme (E-COSP) for Community-Dwelling People with Spinal Cord Injury in people with Spinal Cord Injury and Mental Health, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the programme (time frame: Feasibility will be assessed during the post-intervention, an average of 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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