Online Chronic Pain Therapy for Adults

This study is not yet open for participant recruitment.
Verified April 2012 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01600248
First received: May 10, 2012
Last updated: May 14, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Chronic Pain
Behavioral: Online ABBT for Chronic Pain in Military

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Online Chronic Pain Therapy for Adults

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change from baseline in McGill Pain Questionnaire - Short Form [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A brief self-report questionnaire that measures sensory and affective components of clinical pain.

  • Change from baseline in Chronic Pain Acceptance Questionnaire - Revised [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A 20-item measure of acceptance of chronic pain with items scored from "0 = Never true" to "6 = Always true".

  • Change from baseline in Pain Catastrophizing Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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."

  • Change from baseline in Tampa Scale for Kinesiophobia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A self-report measure of fear of movement and/or re-injury. 17 items rated from "1 = strongly disagree" to "4 = strongly agree"

  • Change from baseline in Pittsburgh Sleep Quality Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval


Secondary Outcome Measures:
  • Client Satisfaction Questionnaire [ Time Frame: At completion of module, approximately 8 weeks ] [ Designated as safety issue: No ]
    An eight item questionnaire regarding client satisfaction with the treatment.

  • Change from baseline in Beck Depression Inventory - Second Edition [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A 21 item self-report measure of severity of depressive symptoms.

  • Change from baseline in Beck Anxiety Inventory [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A 21-item self-report measure assessing severity of symptoms of anxiety

  • Change from baseline in PTSD Checklist - Military Version [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Online ABBT for Chronic Pain in Military
    Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600248

Contacts
Contact: Pamela L Holens, Ph.D. (204) 831-3458 pholens@deerlodge.mb.ca
Contact: Kristen Klassen, M.Sc. (204) 831-3445 kklassen11@deerlodge.mb.ca

Locations
Canada, Manitoba
OSI Clinic, Deer Lodge Centre
Winnipeg, Manitoba, Canada, R3J 0L3
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Pamela L Holens, Ph.D. University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01600248     History of Changes
Other Study ID Numbers: H2012:078
Study First Received: May 10, 2012
Last Updated: May 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Chronic Pain
Military
Veteran
Online
Acceptance

ClinicalTrials.gov processed this record on May 19, 2013