跳至主要内容
临床试验/NCT05390957
NCT05390957Unknown不适用

A Pilot Study of a Revised Online Chronic Pain Treatment for Military, RCMP, and Veterans

University of Manitoba0 个研究点目标入组 34 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
主要终点
Change in pain-related catastrophizing

研究概览

简要总结

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.

详细描述

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 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 is known as ABBT-R. The revised protocol was developed based on feedback from participants who had engaged with the original version and who participated in a focus group study about their experiences. 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. The investigators 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.

The investigators developed an online psychotherapy for chronic pain that utilizes elements of CBT and ACT, and tailored the content specifically to military and police populations. A pilot study evaluating the efficacy of this 8-week, online, acceptance-based behavioral therapy (ABBT) for chronic pain showed reductions in fear of movement/re-injury and pain-related catastrophizing and increases in pain acceptance from pre- to post-treatment. A randomized controlled trial comparing the same ABBT to a waitlist control condition showed the treatment was efficacious for improving pain acceptance, fear of movement/re-injury, and pain-related disability, with treatment effects ranging from large to very large. A recently conducted focus-group study with individuals who had engaged with the treatment provided information about ways to improve the materials to better meet the needs and sensitivities of this population. Based on the feedback from these participants, the original online ABBT has been revised and updated, and the current study will pilot test this new version.

The primary objective of this study is to examine the efficacy of a revised, updated version of an online acceptance-based behavioural therapy (ABBT-R) for addressing chronic pain in military, RCMP, and Veterans of these forces. The secondary objective of this study is to evaluate the impact of the therapy on psychological concerns frequently related to chronic pain in the population to be studied (military, veterans and RCMP/retired RCMP). A tertiary objective of this study is to assess patient satisfaction with the intervention. As revisions to the program were made based on participant feedback, the researchers are interested to know if the modifications made resulted in a more acceptable/satisfying treatment experience.

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 revised version of the intervention, known as ABBT-R, is a six-module (6-week) version of the original ABBT. Although outcomes for individuals who completed the original ABBT intervention were favourable, drop-out rates were high. In efforts to improve the treatment to reduce drop-out rates, the investigators conducted a focus group study with previous participants who had completed the program. Participants suggested a reduction to the length of the treatment as many felt the material could be covered in a shorter amount of time. For this reason, the revised version of the program, ABBT-R, has been reduced to six modules to be completed over a period of six weeks, thereby reducing the length of the treatment. No primary content was removed from the program; however, redundancies were removed, and explanations of concepts were simplified and reduced in length where appropriate. As well, content that was deemed either unpleasant or inappropriate for the intended population was revised or removed.

The online treatment material is administered via the WebCAPSI Therapy program, an online password-protected program which allows participants to progress through the modules at their own pace. Each module is designed to cover a component of ABBT and facilitates understanding of the material through audio files, vignettes, text-based material, and homework exercises/assignments. Modules are designed to be completed in 60 minutes or less and participants have the option to return to the program and the modules as often as they like over the course of the intervention. Upon completion of each module, facilitated through the WebCAPSI Therapy program, participants complete an online assignment in which they provide their responses to three randomly selected questions they previously encountered throughout the module. The primary clinician responds to each online assignment through the WebCAPSI Therapy program within 24-hours of its online submission, providing feedback and encouragement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in pain-related catastrophizing

时间窗: From pre-treatment to post-treatment (approximately 6 weeks)

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.

Change in pain ratings

时间窗: From pre-treatment to post-treatment (approximately 6 weeks)

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.

Change in pain-related acceptance

时间窗: From pre-treatment to post-treatment (approximately 6 weeks)

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.

Change in pain-related fear of movement

时间窗: From pre-treatment to post-treatment (approximately 6 weeks)

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.

Change in pain-related disability

时间窗: From pre-treatment to post-treatment (approximately 6 weeks)

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.

次要结局

  • Change in overall quality of life(From pre-treatment to post-treatment (approximately 6 weeks))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pamela L. Holens

Principal Investigator

University of Manitoba

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