Pilot Study of Revised Online Chronic Pain Treatment for Military and Veterans

NCT05390957 | Unknown

• 1 other identifier: HS25212 (H2021:368)
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to examine the efficacy of a revised version of an online chronic pain intervention tailored specifically for military, RCMP, and veterans. The original intervention from which the revised version emanates is an online psychotherapy for chronic pain that was developed using materials derived from cognitive behavioural therapy (CBT) and acceptance and commitment therapy (ACT) and has thus been described as an acceptance-based behavioural therapy (ABBT). For the purposes of this study, the revised intervention will be known as ABBT-R. The revised treatment protocol was developed based on feedback from participants who had engaged with the original version of the treatment protocol and who participated in a focus group study about their experiences with the intervention. It is hoped that the revised treatment protocol will have similar efficacy to the original treatment protocol and will be as well or better received by participants. We hypothesize that the intervention will be shown to be efficacious for improving pain and pain-related concerns among members of this population and that the treatment will be well received by participants.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Change in pain ratings

  Changes are expected on the McGill Pain Questionnaire-Short Form. On this measure, a higher score means a worse outcome. The primary scale will be examined, which has a minimum of 0 and maximum of 45.

  From pre-treatment to post-treatment (approximately 6 weeks)

• Change in pain-related disability

  Changes are expected on the Pain Disability Index. On this measure, a higher score means a worse outcome. The minimum score is 0 and the maximum is 70.

  From pre-treatment to post-treatment (approximately 6 weeks)

• Change in pain-related catastrophizing

  Changes are expected on the Pain Catastrophizing Scale. On this measure, a higher score means a worse outcome. The minimum score is 0 and the maximum is 52.

  From pre-treatment to post-treatment (approximately 6 weeks)

• Change in pain-related acceptance

  Changes are expected on the Chronic Pain Acceptance Questionnaire-Revised. On this measure, a higher score means a better outcome. The minimum score is 20 and the maximum is 120.

  From pre-treatment to post-treatment (approximately 6 weeks)

• Change in pain-related fear of movement

  Changes are expected on the Tampa Scale of Kinesiophobia- 11 item version. On this measure, a higher score means a worse outcome. The minimum score is 11 and the maximum is 44.

  From pre-treatment to post-treatment (approximately 6 weeks)

Secondary Outcomes (3)

• Change in depression symptoms

  From pre-treatment to post-treatment (approximately 6 weeks)

• Change in posttraumatic stress symptoms

  From pre-treatment to post-treatment (approximately 6 weeks)

• Change in overall quality of life

  From pre-treatment to post-treatment (approximately 6 weeks)

Other Outcomes (1)

• Client satisfaction

  End of treatment measure only (at the end of the 6 week trial)

Study Arms (1)

Single Arm

EXPERIMENTAL

All participants in this pilot study will complete the active treatment

Behavioral: Acceptance Based Behavioural Therapy - Revised

Interventions

Acceptance Based Behavioural Therapy - Revised BEHAVIORAL

The study intervention is a revised, updated version of a previously studied eight-module (8-week) online, acceptance-based behavioural therapy (ABBT) for chronic pain that was tailored specifically to a military, RCMP, and veteran population. The online treatment material is administered via the WebCAPSI Therapy program.

Single Arm

Eligibility Criteria

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

You may qualify if:

• To be eligible to participate in this study, individuals must meet all the following criteria:
• Be either an actively serving or Veteran member of the Canadian Armed Forces or Royal Canadian Mounted Police
• Be over the age of 18
• Have been referred to the Winnipeg Operational Stress Injury Clinic for treatment
• Report chronic pain of duration six months or longer
• Report that they are seeking treatment for their chronic pain
• Have access to a computer at least once per week for a 60-minute duration
• Agree to receive the revised/updated version of the clinic's standard chronic pain treatment
• Provide a signed and dated informed consent form

You may not qualify if:

• An individual who meets any of the following criteria at baseline will be excluded from participation in this study:
• Current uncontrolled or untreated psychosis
• Significant suicide risk
• Seriously impaired concentration
• Significant cognitive impairment
• Unstable living situation

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (21)

• Akerblom S, Perrin S, Rivano Fischer M, McCracken LM. The Relationship Between Posttraumatic Stress Disorder and Chronic Pain in People Seeking Treatment for Chronic Pain: The Mediating Role of Psychological Flexibility. Clin J Pain. 2018 Jun;34(6):487-496. doi: 10.1097/AJP.0000000000000561.

  PMID: 29016388 RESULT

• Andersson G. Internet interventions: Past, present and future. Internet Interv. 2018 Apr 6;12:181-188. doi: 10.1016/j.invent.2018.03.008. eCollection 2018 Jun.

  PMID: 30135782 RESULT

• Blaettler LT, Stewart JA, Gubler DA, Egloff N, von Kanel R, Grosse Holtforth M. Alexithymia moderates effects of psychotherapeutic treatment expectations on depression outcome in interdisciplinary chronic pain treatment. J Psychosom Res. 2019 Jul;122:69-72. doi: 10.1016/j.jpsychores.2019.04.010. Epub 2019 Apr 13.

  PMID: 31010581 RESULT

• Buhler, J., Holens, P., & Sharpe, D. (2021). A Randomized Controlled Trial of an Online Acceptance and Commitment Therapy-based Intervention for Chronic Pain for Military and Police. Military Behavioral Health. https://doi.org/10.1080/21635781.2021.1982086

  RESULT

• Buhrman M, Gordh T, Andersson G. Internet interventions for chronic pain including headache: A systematic review. Internet Interv. 2016 Jan 3;4:17-34. doi: 10.1016/j.invent.2015.12.001. eCollection 2016 May.

  PMID: 30135787 RESULT

• Fayaz A, Croft P, Langford RM, Donaldson LJ, Jones GT. Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies. BMJ Open. 2016 Jun 20;6(6):e010364. doi: 10.1136/bmjopen-2015-010364.

  PMID: 27324708 RESULT

• Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.

  PMID: 22607834 RESULT

• Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine (Phila Pa 1976). 2012 May 15;37(11):E668-77. doi: 10.1097/BRS.0b013e318241e5de.

  PMID: 22146287 RESULT

• Holens, P., Buhler, J., & Klassen, K. (2017). Preliminary Trial of an Online Acceptance-Based Behavioural Treatment for Military, Police, and Veterans with Chronic Pain. Journal of Military, Veteran and Family Health (3), 12-21. https://doi.org/10.3138/jmvfh.4315

  RESULT

• Hunfeld JA, Perquin CW, Duivenvoorden HJ, Hazebroek-Kampschreur AA, Passchier J, van Suijlekom-Smit LW, van der Wouden JC. Chronic pain and its impact on quality of life in adolescents and their families. J Pediatr Psychol. 2001 Apr-May;26(3):145-53. doi: 10.1093/jpepsy/26.3.145.

  PMID: 11259516 RESULT

• Kemler MA, Furnee CA. The impact of chronic pain on life in the household. J Pain Symptom Manage. 2002 May;23(5):433-41. doi: 10.1016/s0885-3924(02)00386-x.

  PMID: 12007761 RESULT

• Libbrecht, A., Paluszek, M., Romaniuk, A., & Holens, P.L., (2021). A Patient-Informed Qualitative Review of an Online Chronic Pain Treatment for Military, Police, and Veterans. Journal of Military, Veteran, and Family Health. https://doi.org/10.3138/jmvfh-2021-0047

  RESULT

• Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.

  PMID: 8598948 RESULT

• Mehta S, Peynenburg VA, Hadjistavropoulos HD. Internet-delivered cognitive behaviour therapy for chronic health conditions: a systematic review and meta-analysis. J Behav Med. 2019 Apr;42(2):169-187. doi: 10.1007/s10865-018-9984-x. Epub 2018 Nov 1.

  PMID: 30387008 RESULT

• Rini C, Williams DA, Broderick JE, Keefe FJ. Meeting them where they are: Using the Internet to deliver behavioral medicine interventions for pain. Transl Behav Med. 2012 Mar;2(1):82-92. doi: 10.1007/s13142-011-0107-2.

  PMID: 22924084 RESULT

• Rosland AM, Heisler M, Piette JD. The impact of family behaviors and communication patterns on chronic illness outcomes: a systematic review. J Behav Med. 2012 Apr;35(2):221-39. doi: 10.1007/s10865-011-9354-4. Epub 2011 Jun 21.

  PMID: 21691845 RESULT

• Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Res Manag. 2011 Nov-Dec;16(6):445-50. doi: 10.1155/2011/876306.

  PMID: 22184555 RESULT

• Van Den Kerkhof, E. G., Carley, M. E., Hopman, W. M., Ross-White, A., & Harrison, M. B. (2014). Prevalence of chronic pain and related risk factors in military veterans: A systematic review. JBI Database of Systematic Reviews and Implementation Reports, 12(10), 152-186. https://doi:10.11124/jbisrir-2014-1720

  RESULT

• Vallejo MA, Ortega J, Rivera J, Comeche MI, Vallejo-Slocker L. Internet versus face-to-face group cognitive-behavioral therapy for fibromyalgia: A randomized control trial. J Psychiatr Res. 2015 Sep;68:106-13. doi: 10.1016/j.jpsychires.2015.06.006. Epub 2015 Jun 20.

  PMID: 26228408 RESULT

• VanDenKerkhof EG, VanTil L, Thompson JM, Sweet J, Hopman WM, Carley ME, Sudom K. Pain in Canadian Veterans: analysis of data from the Survey on Transition to Civilian Life. Pain Res Manag. 2015 Mar-Apr;20(2):89-95. doi: 10.1155/2015/763768. Epub 2015 Jan 20.

  PMID: 25602711 RESULT

• Zanocchi M, Maero B, Nicola E, Martinelli E, Luppino A, Gonella M, Gariglio F, Fissore L, Bardelli B, Obialero R, Molaschi M. Chronic pain in a sample of nursing home residents: prevalence, characteristics, influence on quality of life (QoL). Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):121-8. doi: 10.1016/j.archger.2007.07.003. Epub 2007 Nov 19.

  PMID: 18006088 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pamela L Holens, PhD

CONTACT

204-831-3458; pholens@deerlodge.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is an open label, single site, single arm, pilot study. The primary goal of the study is to examine the efficacy of the ABBT-R program via comparison of pre-treatment and post-treatment scores on measures of pain and other related concerns, as well as examination of participant satisfaction with the program.

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: May 25, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share