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

22 maggio 2022 aggiornato da: Dr. Pamela L. Holens, University of Manitoba

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

34

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Single Arm
All participants in this pilot study will complete the active treatment
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pain ratings
Lasso di tempo: 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.
From pre-treatment to post-treatment (approximately 6 weeks)
Change in pain-related disability
Lasso di tempo: 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.
From pre-treatment to post-treatment (approximately 6 weeks)
Change in pain-related catastrophizing
Lasso di tempo: 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.
From pre-treatment to post-treatment (approximately 6 weeks)
Change in pain-related acceptance
Lasso di tempo: 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.
From pre-treatment to post-treatment (approximately 6 weeks)
Change in pain-related fear of movement
Lasso di tempo: 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.
From pre-treatment to post-treatment (approximately 6 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in depression symptoms
Lasso di tempo: From pre-treatment to post-treatment (approximately 6 weeks)
Changes are expected on the Patient Health Questionnaire-9. On this measure, a higher score means a worse outcome. The minimum score is 0 and the maximum is 27.
From pre-treatment to post-treatment (approximately 6 weeks)
Change in posttraumatic stress symptoms
Lasso di tempo: From pre-treatment to post-treatment (approximately 6 weeks)
Changes are expected on the Posttraumatic Checklist - DSM5 version. On this measure, a higher score means a worse outcome. The minimum score is 0 and the maximum score is 80.
From pre-treatment to post-treatment (approximately 6 weeks)
Change in overall quality of life
Lasso di tempo: From pre-treatment to post-treatment (approximately 6 weeks)
Changes are expected on the Short-Form Health Survey - 20 item version. On this measure, a higher score means a better outcome. The minimum score is 20 and the maximum is 91.
From pre-treatment to post-treatment (approximately 6 weeks)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Client satisfaction
Lasso di tempo: End of treatment measure only (at the end of the 6 week trial)
Client satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8) and compared to outcomes from a trial of a previous version of this treatment. The measure has 8 items. Higher scores are associated with better outcomes. The minimum is 8 and the maximum is 32.
End of treatment measure only (at the end of the 6 week trial)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

15 giugno 2022

Completamento primario (Anticipato)

31 dicembre 2022

Completamento dello studio (Anticipato)

31 dicembre 2022

Date di iscrizione allo studio

Primo inviato

8 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2022

Primo Inserito (Effettivo)

25 maggio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 maggio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HS25212 (H2021:368)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore cronico

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