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

NCT05535400 | Completed

• 1 other identifier: P0038951
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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". 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.

Conditions

Spinal Cord Injuries; Physical Inactivity; Depression; Chronic Pain

Keywords

Spinal cord injuries; Physical Psychological Integrative

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Exercise Efficacy at post test

  Exercise efficacy will be assessed at post-intervention, an average of two months.

• Exercise Efficacy at three months follow-up

  Exercise Efficacy will be assessed after three months follow-up.

• Mindfulness at post test

  Mindfulness will be assessed at post-intervention, an average of two months.

• Mindfulness at three months follow-up

  Mindfulness will be assessed after three months follow-up.

• QoL: Quality of Life at post test

  Quality of Life will be assessed at post-intervention, an average of two months.

Study Arms (2)

The Physical-Psychological Integrative (PPI) intervention group

EXPERIMENTAL

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

The brief online didactic education control group

ACTIVE COMPARATOR

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

Interventions

Physical-Psychological Integrative Intervention BEHAVIORAL

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 Physical-Psychological Integrative (PPI) intervention group

Brief online didactic education DEVICE

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.

The brief online didactic education control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic Unviersity

Hong Kong, Hong Kong

Location

Related Publications (27)

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• Veerubhotla A, Hong E, Knezevic S, Spungen A, Ding D. Estimation of Physical Activity Intensity in Spinal Cord Injury Using a Wrist-Worn ActiGraph Monitor. Arch Phys Med Rehabil. 2020 Sep;101(9):1563-1569. doi: 10.1016/j.apmr.2020.05.014. Epub 2020 Jun 2.

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• Li Y, Li M, Bressington D, Li K, Wong AY, Chung WM, Molassiotis A, Ma CZ, Kor PPK, Yeung WF. Effect of a Mindfulness and Motivational Interviewing-Oriented Physical-Psychological Integrative Intervention for Community-Dwelling Spinal Cord Injury Survivors: A Mixed-Methods Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Sep;105(9):1632-1641. doi: 10.1016/j.apmr.2024.05.017. Epub 2024 May 22.

  PMID: 38782232 DERIVED

• Li Y, Wong A, Chung WM, Li M, Molasiotis A, Bressington D, Ma CZ, Kor PPK, Yeung WF. Evaluation of a Physical-Psychological Integrative (PPI) intervention for community-dwelling spinal cord injury survivors: Study protocol of a preliminary randomized controlled trial. PLoS One. 2023 Mar 20;18(3):e0282846. doi: 10.1371/journal.pone.0282846. eCollection 2023.

  PMID: 36940214 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Sedentary Behavior; Depression; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior; Behavioral Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Li, Dr

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants could not be blinded due to the nature of the intervention. Patients will be reminded to keep the intervention content confidential and not discuss this with participants in the control group to avoid contamination. Also, the research assistant (RA1) who responsible for assessing all the outcomes will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: September 10, 2022
• Study Start: September 20, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: April 10, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)