Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial

Study Overview
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Brief Summary
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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. 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.

Detailed Description
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This study is a two-arm, single-blind pilot randomized controlled trial, and it will be adopted to evaluate or compare the effects between the Physical-Psychological Integrative (PPI) intervention group and the brief online didactic education control group. 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.

Official Title
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Effects of a Physical-Psychological Integrative (PPI) Intervention on Physical Inactivity, Depression and Chronic Pain for Community-Dwelling Spinal Cord Injury Survivors: a Pilot Randomized Controlled Trial

Conditions
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Spinal Cord Injuries, Physical Inactivity, Depression, Chronic Pain

Intervention / Treatment
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* Behavioral: Physical-Psychological Integrative Intervention
* Device: Brief online didactic education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years older; 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: Presented with any significant cognitive impairment or brain injury; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We aim to have two study group, including the eight-week Physical-Psychological Integrative online intervention group and the brief online didactic education control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Physical-Psychological Integrative (PPI) intervention group<br>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 | Behavioral: Physical-Psychological Integrative Intervention<br>* 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.<br>|
| Active Comparator: The brief online didactic education control group<br>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. | Device: Brief online didactic education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leisure-time Physical Activity | Participants' leisure-time moderated-to-rigorous physical activity (MVPA) will be assessed by using the Fitbug Orb (Chicago, IL) which is a wearable, display, triaxial accelerometer that pairs with Bluetooth with compatible smartphones. | Leisure-time Physical Activity will be assessed throughout the study period, an average of two months. | 
| Depression at post-test | The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level. | Depression will be assessed at post-intervention, an average of two months. | 
| Depression at three months follow-up | The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level. | Depression will be assessed after three months follow-up. | 
| Chronic pain at post test | An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain. | Chronic pain will be assessed at post-intervention, an average of two months. | 
| Chronic pain at three months follow-up | An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain. | Chronic pain will be assessed after three months follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Efficacy at post test | A scale aim at testing people's confidence to continue exercising in the face of barriers to exercise. | Exercise efficacy will be assessed at post-intervention, an average of two months. | 
| Exercise Efficacy at three months follow-up | A scale aim at testing people's confidence to continue exercising in the face of barriers to exercise. | Exercise Efficacy will be assessed after three months follow-up. | 
| Mindfulness at post test | The 39-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measuring the five aspects of mindfulness including observing, describing, acting with awareness, non-judgmental and non-reactive. | Mindfulness will be assessed at post-intervention, an average of two months. | 
| Mindfulness at three months follow-up | The 39-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measuring the five aspects of mindfulness including observing, describing, acting with awareness, non-judgmental and non-reactive. | Mindfulness will be assessed after three months follow-up. | 
| QoL: Quality of Life at post test | The 26-item World Health Organization Quality of Life Brief Scale will be used for assessing participants' quality of life. | Quality of Life will be assessed at post-intervention, an average of two months. | 
| QoL: Quality of Life at three months follow up | The 26-item World Health Organization Quality of Life Brief Scale will be used for assessing participants' quality of life. | Quality of Life will be assessed after three months follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injuries, Physical Psychological Integrative