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Online Chronic Pain Therapy for Adults

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01600248
First received: May 10, 2012
Last updated: October 20, 2014
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: May 2015
Estimated Primary Completion Date: February 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: October 20, 2014
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014