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Clinical Trials/NCT00651924
NCT00651924
Completed
Not Applicable

Piloting Interactive Voice Response Modules for Chronic Pain Treatment

US Department of Veterans Affairs1 site in 1 country27 target enrollmentDecember 2008
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
US Department of Veterans Affairs
Enrollment
27
Locations
1
Primary Endpoint
Comprehension
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This study is designed to develop and test the use of Interactive Voice Response (IVR) technology to deliver pain management treatment. IVR allows individuals to receive and provide information by using their touchtone telephone. This will allow more people with chronic pain to receive treatment even if they are not able to drive to an appointment regularly. In the first part of the study, the investigators will develop new materials like patient handbooks and pre-recorded explanations about common pain control techniques. In the second part of the study, a small number of persons with chronic pain will receive treatment using the new materials. We will ask for their feedback about how well they liked using the new materials and if the materials are understandable. This will allow us to revise the materials if we need to prior to studying them with a larger group of people with chronic pain.

Detailed Description

Background: Cognitive behavioral therapy (CBT) has been shown in two meta-analyses to be effective in reducing pain intensity, disability, and affective distress in persons with chronic pain. Although effective, traditional CBT is time-intensive and requires patients to make frequent office visits. An alternative is to improve treatment accessibility and efficiency of treatment provision through the use of electronic methods such as interactive voice response (IVR) technology. Objectives: This pilot project was designed to test the feasibility and perceived value of IVR-based CBT intervention materials for the treatment of chronic pain. The project involved adapting traditional CBT materials for use in a IVR-based chronic pain treatment. Methods: The project occurred in two phases. Phase 1 included the revision of materials to support the IVR-based intervention including 1) a patient handbook, 2) a library of IVR-compatible scripts for the presentation of pain treatment topics, and 3) guidelines for providing personalized feedback. Phase 2 included the evaluation of the developed materials by a small group of patients with chronic pain. After the treatment materials were revised, their usability, feasibility and perceived value were tested with a small sample of Veterans with chronic pain. Status: This study is complete.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
April 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pain for at least 6 months;
  • Average pain level of \>3 on a scale of 0 (no pain) to 10 (worst imaginable);
  • Access to touchtone phone

Exclusion Criteria

  • Current alcohol or substance abuse;
  • Current psychosis;
  • Current suicidal ideation;
  • Current life threatening or acute physical illness

Outcomes

Primary Outcomes

Comprehension

Time Frame: Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)

Each treatment session had 5 True / False questions that corresponded with the material in the patient handbook. Phase 1 participants reviewed individual treatment modules in the patient handbook to provide immediate feedback regarding how understandable, engaging, and informative they find the materials. Phase 2 participants' used the patient materials as part of treatment and the true/false questions were used to evaluate comprehension of the materials. Example questions: Chronic pain can affect how you feel physically and emotionally (T); Relaxation is the same as being lazy and unproductive (F).

Study Sites (1)

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