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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
History of Changes
  Purpose

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.


Condition Intervention
Chronic Pain
 Behavioral: IVR-based Cognitive-behavior therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Piloting Interactive Voice Response Modules for Chronic Pain Treatment

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
treatment using IVR-based modules
 Behavioral: IVR-based Cognitive-behavior therapy
Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651924

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Robert D. Kerns, PhD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00651924     History of Changes
Other Study ID Numbers: SHP 08-147
Study First Received: March 31, 2008
Last Updated: April 23, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic pain
IVR
cognitive-behavior therapy

ClinicalTrials.gov processed this record on May 19, 2013