Chronic Pain
Conditions
Keywords
chronic pain, IVR, cognitive-behavior therapy
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.
Interventions
BEHAVIORALIVR-based Cognitive-behavior therapy
Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
Sponsors
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehension | Immediately after review of materials (phase 1); 1 week post review of materials (phase 2) | 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). |
Countries
United States
Participant flow
Recruitment details
Recruited Dec. 2008-May 2012 for all phases. Participants were recruited from a Comprehensive Pain Clinic and through provider referral.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are. | 18 |
| 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 | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by PI | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Phase 1 | Phase 2 | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 8.25 | 56 years STANDARD_DEVIATION 17 | 55 years STANDARD_DEVIATION 11 |
| Pain Severity | 6.33 units on a scale STANDARD_DEVIATION 1.77 | 5.88 units on a scale STANDARD_DEVIATION 0.63 | 6.21 units on a scale STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Black | 6 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 11 participants | 6 participants | 17 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 17 Participants | 6 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 9 |
| serious Total, serious adverse events | 0 / 18 | 0 / 9 |
Outcome results
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).
Time frame: Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 | Comprehension | 92.14 Percent of questions answered correctly | Standard Deviation 12.51 |
| Phase 2 | Comprehension | 96.42 Percent of questions answered correctly | Standard Deviation 9.29 |