Clinical trial NCT05390957: Pilot Study of Revised Online Chronic Pain Treatment for Military and Veterans
Official title: A Pilot Study of a Revised Online Chronic Pain Treatment for Military, RCMP, and Veterans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Based on a recommendation from the HREB during the pilot study of the original ABBT, to incorporate an element of face-to-face contact between participants and the primary clinician during their engagement with the online materials, optional biweekly group sessions are also offered to participants. In the initial optional group session, the clinician provides an overview of the treatment with a specific focus on what to expect in the first two online modules. Each subsequent session revolves around discussion of participant experiences with the previous two online modules, and an overview of what to expect in the next two. Participants who choose not to participate in the group sessions instead participate in individual check-in sessions with the primary clinician at the beginning, mid-point, and end-point of treatment. Throughout their engagement with the intervention, participants can contact the clinician by sending a message through the WebCAPSI Therapy website or by phoning the clinician directly.

The study is a pilot study of an updated and revised version of an existing efficacious therapy. The study uses a single-subject design in which individuals serve as their own controls as a first step in evaluating the efficacy of the revised intervention. 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. The researchers hypothesize that there will be a reduction in chronic pain symptoms and related concerns following completion of ABBT-R, and that the revised version will be rated as satisfactory by participants.

The source of potential participants is an existing waitlist for chronic pain treatment at the OSI Clinic. Recruitment will proceed via contact by one of the study personnel who has access to the waiting list, as a treatment provider at the clinic. The study personnel will describe the treatment and the study to the potential participants, advise them that they can receive treatment whether they participate in the study or not, and ascertain their willingness to participate.

Potential participants will be told that they are being contacted because they are on the waiting list for chronic pain treatment at the clinic and asked if they are still wishing to receive treatment at the clinic for their chronic pain. Those who indicate they wish to receive treatment will be told about the standard chronic pain treatment at the clinic and advised that the original treatment materials have recently been revised and updated, and that we are doing a research study to determine whether the revised version of the treatment is as effective as the original version.

Participants will be told that if they do not wish to be a part of the study, they have the option of receiving treatment with either the original version or the updated, revised version of the treatment. All individuals wishing to receive treatment will be screened for appropriateness for the treatment, and for those indicating willingness to be a part of the study, the Informed Consent Form will be reviewed with them over the phone and arrangements will be made for a copy of the form to be mailed to them for their signature, with a stamped, return-addressed envelope.

The investigators aim to recruit 34 participants to have adequate power to test the key hypotheses. Statistical analyses will be conducted using SPSS version 27.0. Standard procedures for data screening, preparation, assessing assumptions of normality, and dealing with missing data and outliers will be used prior to hypothesis testing. Reliability for each of the measures used in the study will be calculated using Cronbach's alpha. The primary and secondary hypotheses will be tested using paired sample t-tests to compare participants' pre-, and post-treatment scores on the various measures of chronic pain and other related concerns (i.e., depression, PTSD, and quality of life). The tertiary hypothesis will be examined by comparing participants' scores on the client satisfaction questionnaire to published norms using an independent samples t-test. Effect sizes will be calculated for all outcomes.

Eligibility criteria: Inclusion Criteria:

* To be eligible to participate in this study, individuals must meet all the following criteria:

  1. Be either an actively serving or Veteran member of the Canadian Armed Forces or Royal Canadian Mounted Police
  2. Be over the age of 18
  3. Have been referred to the Winnipeg Operational Stress Injury Clinic for treatment
  4. Report chronic pain of duration six months or longer
  5. Report that they are seeking treatment for their chronic pain
  6. Have access to a computer at least once per week for a 60-minute duration
  7. Agree to receive the revised/updated version of the clinic's standard chronic pain treatment
  8. Provide a signed and dated informed consent form

Exclusion Criteria:

* An individual who meets any of the following criteria at baseline will be excluded from participation in this study:

  1. Current uncontrolled or untreated psychosis
  2. Significant suicide risk
  3. Seriously impaired concentration
  4. Significant cognitive impairment
  5. Unstable living situation

Primary outcomes:
measure: Change in pain ratings
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
measure: Change in pain-related disability
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
measure: Change in pain-related catastrophizing
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
measure: Change in pain-related acceptance
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
measure: Change in pain-related fear of movement
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
Secondary outcomes:
measure: Change in depression symptoms
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
measure: Change in posttraumatic stress symptoms
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
measure: Change in overall quality of life
timeFrame: From pre-treatment to post-treatment (approximately 6 weeks)
Other outcomes:
measure: Client satisfaction
timeFrame: End of treatment measure only (at the end of the 6 week trial)
Locations:
Study officials:
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