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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: October 28, 2014
Last verified: October 2014
  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: Allocation: Non-Randomized
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:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Comprehension [ Time Frame: Immediately after review of materials (phase 1); 1 week post review of materials (phase 2) ] [ Designated as safety issue: No ]
    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).


Enrollment: 27
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
No Intervention: Phase 1
Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are
Experimental: Phase 2
Piloting the 'IVR-based Cognitive-behavior therapy' using the new materials
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Results First Received: September 17, 2014
Last Updated: October 28, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014