Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment

NCT ID: NCT00651924

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-04-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Phase 1

Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are

Group Type: NO_INTERVENTION

No interventions assigned to this group

Phase 2

Piloting the 'IVR-based Cognitive-behavior therapy' using the new materials

Group Type: EXPERIMENTAL

IVR-based Cognitive-behavior therapy

Intervention Type: BEHAVIORAL

Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts

Interventions

IVR-based Cognitive-behavior therapy

Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D. Kerns, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

SHP 08-147

Identifier Type: -

Identifier Source: org_study_id