- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01600248
Online Chronic Pain Therapy for Adults
19. august 2015 opdateret af: University of Manitoba
This study will evaluate the usefulness of an online, self-directed treatment for chronic pain that has been designed specifically for individuals who are currently or have previously served in the military.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will evaluate the efficacy of an eight-module, online, self-directed treatment for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the treatment modality.
The online modules are tailored to the unique issues of individuals with a military background.
The modules will be delivered via the WebCAPSI Therapy program, an online, password-protected program that allows participants to anonymously progress through all modules at their own pace.
ABBT modules cover the following: Introduction, Acceptance, Values, Cognitive Defusion, Mindfulness, Exercise/Pacing/Communication Skills, Self-as-Context, and Willingness.
Modules encourage understanding of the information through audio files, military-specific vignettes, written materials, and homework exercises.
Modules are designed to be completed in 60 minutes or less.
Participants will have access to the online treatment for a three month period and will be encouraged to complete one module per week.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R3J 0L3
- OSI Clinic, Deer Lodge Centre
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Chronic pain condition of duration 6 months or longer
- Patient at OSI Clinic in Winnipeg
- Access to a computer with internet at least once per week for 60 minutes
Exclusion Criteria:
- Active psychosis
- Actively suicidal
- Unstable living conditions
- Seriously impaired concentration
- Inability to read and write in English
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Treatment arm
This is an open-label pilot study with no control group.
Participants pre-treatment scores are compared to their post-treatment scores.
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Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in McGill Pain Questionnaire - Short Form
Tidsramme: 8 weeks
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A brief self-report questionnaire that measures sensory and affective components of clinical pain.
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8 weeks
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Change from baseline in Chronic Pain Acceptance Questionnaire - Revised
Tidsramme: 8 weeks
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A 20-item measure of acceptance of chronic pain with items scored from "0 = Never true" to "6 = Always true".
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8 weeks
|
Change from baseline in Pain Catastrophizing Scale
Tidsramme: 8 weeks
|
One of the most widely used instruments for measuring catastrophic thinking related to pain.
A 13-item measure with items rated from "0 = Not at all" to "4 = All the time."
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8 weeks
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Change from baseline in Tampa Scale for Kinesiophobia
Tidsramme: 8 weeks
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A self-report measure of fear of movement and/or re-injury.
17 items rated from "1 = strongly disagree" to "4 = strongly agree"
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8 weeks
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Change from baseline in Pittsburgh Sleep Quality Index
Tidsramme: 8 weeks
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A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
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8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Client Satisfaction Questionnaire
Tidsramme: At completion of module, approximately 8 weeks
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An eight item questionnaire regarding client satisfaction with the treatment.
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At completion of module, approximately 8 weeks
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Change from baseline in Beck Depression Inventory - Second Edition
Tidsramme: 3 months
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A 21 item self-report measure of severity of depressive symptoms.
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3 months
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Change from baseline in Beck Anxiety Inventory
Tidsramme: 3 months
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A 21-item self-report measure assessing severity of symptoms of anxiety
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3 months
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Change from baseline in PTSD Checklist - Military Version
Tidsramme: 3 months
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A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pamela L Holens, Ph.D., University of Manitoba
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2012
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
10. maj 2012
Først indsendt, der opfyldte QC-kriterier
14. maj 2012
Først opslået (Skøn)
17. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H2012:078
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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