NCT01600248

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

2.7 years

First QC Date

May 10, 2012

Last Update Submit

August 19, 2015

Conditions

Keywords

Chronic PainMilitaryVeteranOnlineAcceptance

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in McGill Pain Questionnaire - Short Form

    A brief self-report questionnaire that measures sensory and affective components of clinical pain.

    8 weeks

  • Change from baseline in Chronic Pain Acceptance Questionnaire - Revised

    A 20-item measure of acceptance of chronic pain with items scored from "0 = Never true" to "6 = Always true".

    8 weeks

  • Change from baseline in Pain Catastrophizing Scale

    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."

    8 weeks

  • Change from baseline in Tampa Scale for Kinesiophobia

    A self-report measure of fear of movement and/or re-injury. 17 items rated from "1 = strongly disagree" to "4 = strongly agree"

    8 weeks

  • Change from baseline in Pittsburgh Sleep Quality Index

    A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval

    8 weeks

Secondary Outcomes (4)

  • Client Satisfaction Questionnaire

    At completion of module, approximately 8 weeks

  • Change from baseline in Beck Depression Inventory - Second Edition

    3 months

  • Change from baseline in Beck Anxiety Inventory

    3 months

  • Change from baseline in PTSD Checklist - Military Version

    3 months

Study Arms (1)

Treatment arm

OTHER

This is an open-label pilot study with no control group. Participants pre-treatment scores are compared to their post-treatment scores.

Behavioral: Online ABBT for Chronic Pain in Military

Interventions

Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.

Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active psychosis
  • Actively suicidal
  • Unstable living conditions
  • Seriously impaired concentration
  • Inability to read and write in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSI Clinic, Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela L Holens, Ph.D.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 17, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations