Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment

Study Overview
=================
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.

Official Title
-----------------
Piloting Interactive Voice Response Modules for Chronic Pain Treatment

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: IVR-based Cognitive-behavior therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Phase 1<br>Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are | |
| Experimental: Phase 2<br>Piloting the 'IVR-based Cognitive-behavior therapy' using the new materials | Behavioral: IVR-based Cognitive-behavior therapy<br>* Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pain, IVR, cognitive-behavior therapy