Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00651924
First received: March 31, 2008
Last updated: April 23, 2012
Last verified: May 2009

March 31, 2008
April 23, 2012
December 2008
March 2009   (final data collection date for primary outcome measure)
module satisfaction ratings [ Time Frame: phase 1: subject satisfaction and comprehension; phase 2: weekly during treatment and immediately post-treatment (10 weeks) ] [ Designated as safety issue: No ]
module satisfaction ratings [ Time Frame: weekly during treatment and immediately post-treatment (10 weeks) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00651924 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment
Piloting Interactive Voice Response Modules for Chronic Pain Treatment

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Chronic Pain
Behavioral: IVR-based Cognitive-behavior therapy
Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
Experimental: Arm 1
treatment using IVR-based modules
Intervention: Behavioral: IVR-based Cognitive-behavior therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
April 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00651924
SHP 08-147
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Robert D. Kerns, PhD VA Connecticut Health Care System (West Haven)
Department of Veterans Affairs
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP