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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVR-based Cognitive-behavior therapy | Behavioral | Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D. Kerns, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States |
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Recruited Dec. 2008-May 2012 for all phases. Participants were recruited from a Comprehensive Pain Clinic and through provider referral.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 | Review of materials and provide feedback regarding how understandable, engaging, and informative the materials are. Revisions will be made based on this feedback. |
| FG001 | Phase 2 | Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Phase 2: two individuals completed all 10 sessions of treatment, however, we have baseline measures on 6 individuals (1 dropped after 5 sessions, 2 dropped after 1 session, 1 dropped after 2 sessions and 1 dropped after 4 sessions).
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 | Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are. |
| BG001 | Phase 2 | Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Per protocol | Posted | Mean | Standard Deviation | Percent of questions answered correctly | Immediately after review of materials (phase 1); 1 week post review of materials (phase 2) |
|
12/02/2008 - 01/21/2011]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 | Review of newly created materials and provide feedback regarding how understandable, engaging, and informative the materials are. |
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Difficulty recruiting for phase 2 lead to a small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Kerns, Ph.D. | VA Connecticut Healthcare System | 203-932-5711 | 3841 | robert.kerns@va.gov |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Pain Severity | 10 point likert scale: 0 No Pain at All - 10 Worst Pain Imaginable Missing data for 11 patients (Phase 1- 9; Phase 2 - 2) | Mean | Standard Deviation | units on a scale |
|
| OG001 | Phase 2 | Pilot IVR-based CBT treatment |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Phase 2 | Pilot the newly developed materials during a 10-week course of cognitive behavioral therapy for chronic pain | 0 | 9 | 0 | 9 |
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