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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535400
• Other study ID #: P0038951
• Status: Completed
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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".

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Physical Inactivity
• Spinal Cord Injuries

Intervention

Behavioral:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic Unviersity	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (25)

Alizadeh A, Dyck SM, Karimi-Abdolrezaee S. Traumatic Spinal Cord Injury: An Overview of Pathophysiology, Models and Acute Injury Mechanisms. Front Neurol. 2019 Mar 22;10:282. doi: 10.3389/fneur.2019.00282. eCollection 2019. — View Citation

Avluk OC, Gurcay E, Gurcay AG, Karaahmet OZ, Tamkan U, Cakci A. Effects of chronic pain on function, depression, and sleep among patients with traumatic spinal cord injury. Ann Saudi Med. 2014 May-Jun;34(3):211-6. doi: 10.5144/0256-4947.2014.211. — View Citation

Best KL, Routhier F, Sweet SN, Lacroix E, Arbour-Nicitopoulos KP, Borisoff JF. Smartphone-Delivered Peer Physical Activity Counseling Program for Individuals With Spinal Cord Injury: Protocol for Development and Pilot Evaluation. JMIR Res Protoc. 2019 Mar 22;8(3):e10798. doi: 10.2196/10798. — View Citation

Boldt I, Eriks-Hoogland I, Brinkhof MW, de Bie R, Joggi D, von Elm E. Non-pharmacological interventions for chronic pain in people with spinal cord injury. Cochrane Database Syst Rev. 2014 Nov 28;(11):CD009177. doi: 10.1002/14651858.CD009177.pub2. — View Citation

Bombardier CH, Dyer JR, Burns P, Crane DA, Takahashi MM, Barber J, Nash MS. A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial. Spinal Cord. 2021 Jan;59(1):63-73. doi: 10.1038/s41393-020-0523-6. Epub 2020 Jul 21. — View Citation

Bombardier CH, Richards JS, Krause JS, Tulsky D, Tate DG. Symptoms of major depression in people with spinal cord injury: implications for screening. Arch Phys Med Rehabil. 2004 Nov;85(11):1749-56. doi: 10.1016/j.apmr.2004.07.348. — View Citation

Burch V, Penman D. Mindfulness for health: a practical guide to relieving pain, reducing stress and restoring wellbeing: Hachette UK; 2013.

Fann JR, Crane DA, Graves DE, Kalpakjian CZ, Tate DG, Bombardier CH. Depression treatment preferences after acute traumatic spinal cord injury. Arch Phys Med Rehabil. 2013 Dec;94(12):2389-2395. doi: 10.1016/j.apmr.2013.07.004. Epub 2013 Jul 16. — View Citation

Hadjipavlou G, Cortese AM, Ramaswamy B. Spinal cord injury and chronic pain. BJA Education. 2016;16(8):264-8.

Hearn JH, Cross A. Mindfulness for pain, depression, anxiety, and quality of life in people with spinal cord injury: a systematic review. BMC Neurol. 2020 Jan 21;20(1):32. doi: 10.1186/s12883-020-1619-5. — View Citation

Hearn JH, Finlay KA. Internet-delivered mindfulness for people with depression and chronic pain following spinal cord injury: a randomized, controlled feasibility trial. Spinal Cord. 2018 Aug;56(8):750-761. doi: 10.1038/s41393-018-0090-2. Epub 2018 Mar 26. — View Citation

Heutink M, Post MW, Luthart P, Schuitemaker M, Slangen S, Sweers J, Vlemmix L, Lindeman E. Long-term outcomes of a multidisciplinary cognitive behavioural programme for coping with chronic neuropathic spinal cord injury pain. J Rehabil Med. 2014 Jun;46(6):540-5. doi: 10.2340/16501977-1798. — View Citation

Hu Y, Mak JN, Wong YW, Leong JC, Luk KD. Quality of life of traumatic spinal cord injured patients in Hong Kong. J Rehabil Med. 2008 Feb;40(2):126-31. doi: 10.2340/16501977-0150. — View Citation

Khazaeipour Z, Taheri-Otaghsara SM, Naghdi M. Depression Following Spinal Cord Injury: Its Relationship to Demographic and Socioeconomic Indicators. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):149-55. doi: 10.1310/sci2102-149. Epub 2015 Apr 12. — View Citation

Li Y, Bressington D, Chien WT. Pilot evaluation of a coping-oriented supportive program for people with spinal cord injury during inpatient rehabilitation. Disabil Rehabil. 2019 Jan;41(2):182-190. doi: 10.1080/09638288.2017.1386238. Epub 2017 Oct 10. — View Citation

Li Y, Chien WT, Bressington D. Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study. Spinal Cord. 2020 Jan;58(1):58-69. doi: 10.1038/s41393-019-0320-2. Epub 2019 Jun 28. Erratum In: Spinal Cord. 2020 Dec;58(12):1327. — View Citation

March ICfCoSCIPJI. Global summary of spinal cord injury, incidence and economic impact. 2004.

Margolis JM, Juneau P, Sadosky A, Cappelleri JC, Bryce TN, Nieshoff EC. Health care resource utilization and medical costs of spinal cord injury with neuropathic pain in a commercially insured population in the United States. Arch Phys Med Rehabil. 2014 Dec;95(12):2279-87. doi: 10.1016/j.apmr.2014.07.416. Epub 2014 Aug 24. — View Citation

Martin Ginis KA, Jetha A, Mack DE, Hetz S. Physical activity and subjective well-being among people with spinal cord injury: a meta-analysis. Spinal Cord. 2010 Jan;48(1):65-72. doi: 10.1038/sc.2009.87. Epub 2009 Jul 7. — View Citation

Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20. — View Citation

Richardson L. Motivational interviewing: helping patients move toward change. J Christ Nurs. 2012 Jan-Mar;29(1):18-24; quiz 25-6. doi: 10.1097/cnj.0b013e318238e510. — View Citation

Strategy and Action Plan to Prevent and Control Non-communicable Diseases in Hong Kong. Food and Health Burean, Hong Kong.

Vall J, Costa CM, Pereira LF, Friesen TT. Application of International Classification of Functioning, Disability and Health (ICF) in individuals with spinal cord injury. Arq Neuropsiquiatr. 2011 Jun;69(3):513-8. doi: 10.1590/s0004-282x2011000400020. — View Citation

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. — View Citation

Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.