Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment

NCT00651924 | Completed Results

• 1 other identifier: SHP 08-147
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; IVR; cognitive-behavior therapy

Outcome Measures

Primary Outcomes (1)

• Comprehension

  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).

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

Study Arms (2)

Phase 1

NO INTERVENTION

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

Phase 2

EXPERIMENTAL

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

Behavioral: IVR-based Cognitive-behavior therapy

Interventions

IVR-based Cognitive-behavior therapy BEHAVIORAL

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

Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

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

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Difficulty recruiting for phase 2 lead to a small number of subjects analyzed.

Results Point of Contact

• Title: Robert Kerns, Ph.D.
• Organization: VA Connecticut Healthcare System

robert.kerns@va.gov

203-932-5711

Study Officials

• Robert D. Kerns, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 28, 2015
• Results First Posted: October 21, 2014

Record last verified: 2014-06

Locations

US (1)