Online Chronic Pain Therapy for Adults

Chronic Pain Clinical Trial

Official title:

Online Chronic Pain Therapy for Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600248
• Other study ID #: H2012:078
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: August 19, 2015
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	OSI Clinic, Deer Lodge Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Client Satisfaction Questionnaire	An eight item questionnaire regarding client satisfaction with the treatment.	At completion of module, approximately 8 weeks	No
Secondary	Change from baseline in Beck Depression Inventory - Second Edition	A 21 item self-report measure of severity of depressive symptoms.	3 months	Yes
Secondary	Change from baseline in Beck Anxiety Inventory	A 21-item self-report measure assessing severity of symptoms of anxiety	3 months	No
Secondary	Change from baseline in PTSD Checklist - Military Version	A 17-item self-report measure assessing severity of PTSD symptoms related to stressful military experiences.	3 months	No