Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial
NCT ID: NCT05535400
Last Updated: 2024-04-10
Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2022-09-20
2023-07-01
Brief Summary
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The PPI intervention group participants will indicate significantly greater improvements when compared with those in control group in the minutes of performing the moderate-to-rigorous physical activity, depression, chronic pain and mindfulness skills and quality of life at post-intervention, and three months follow-up. The use of psychological motivational interviewing and online face-to-face meetings will be good modalities for the people with SCI to overcome the barriers of not having face-to-face interactions and transportation problems. And the intervention would be feasible and improve SCI people's physical inactivity, depression and chronic pain as to step up the control of the modifiable risk factors for non-communicable diseases.
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Detailed Description
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Seventy-two participants will be recruited from the Hong Kong Direction Association for the Handicapped. 36 people with SCI will be assigned to intervention or control group. Participants in PPI Intervention group will receive a Fitbug wristband activity trackers and exercise bands as an incentive and encouragement for doing more physical exercises. The intervention includes eight weekly online group sessions. Qualitative interviews with the PPI intervention group participants will be conducted to understand their acceptance and perceived strengths and limitations of the intervention programme. While the one in the control group will receive a short video call for general physical and psychological suggestions. This can help to control the contact effects of the PPI intervention. Primary outcomes will be leisure-time physical activity, depression and chronic pain. Secondary outcome will be exercise efficacy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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The Physical-Psychological Integrative (PPI) intervention group
The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program, followed by on-line group psychological intervention
Physical-Psychological Integrative Intervention
The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program. And the content of the intervention includes eight different sessions, including Session 1- Orientation and engagement, Session 2- Awareness and Acceptance; Session 3- Non-judgement; Session 4- Stay present and let go; Session 5- Our thoughts are not real \& Response without reacting; Session 6- Empowerment of self-management and discuss pain management; Session 7- Seek out pleasant things and social support and Session 8- Review the intervention and end the programme.
The brief online didactic education control group
Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.
Brief online didactic education
Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.
Interventions
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Physical-Psychological Integrative Intervention
The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program. And the content of the intervention includes eight different sessions, including Session 1- Orientation and engagement, Session 2- Awareness and Acceptance; Session 3- Non-judgement; Session 4- Stay present and let go; Session 5- Our thoughts are not real \& Response without reacting; Session 6- Empowerment of self-management and discuss pain management; Session 7- Seek out pleasant things and social support and Session 8- Review the intervention and end the programme.
Brief online didactic education
Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.
Eligibility Criteria
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Inclusion Criteria
* Currently living in the community and having SCI for more than 6 months;
* Complete injury at the C6 or below or incomplete injury at any level ;
* Having a computer/ smartphone with audio-speaking function and Zoom software, and internet access in a secure place;
* Using a wheelchair for at least 2 hours a day and having the approval from the physicians to perform exercises;
* Having no problems in hearing, verbal communication, and vision;
* Able to communicate in Cantonese and to provide informed consent.
Exclusion Criteria
* Engaged in ongoing psychotherapy or any other physiotherapy/ exercise/ relaxation interventions;
* Physically active for more than 150 minutes per week;
* Experiencing significant psychotic symptoms, substance misuse or medically not able for the exercise and psychological programme as diagnosed by their physicians.
18 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Principal Investigators
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Yan Li, Dr
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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School of Nursing, The Hong Kong Polytechnic Unviersity
Hong Kong, , Hong Kong
Countries
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References
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Other Identifiers
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P0038951
Identifier Type: -
Identifier Source: org_study_id
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