Trial Outcomes & Findings for Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment (NCT NCT00651924)
NCT ID: NCT00651924
Last Updated: 2015-04-28
Results Overview
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).
COMPLETED
NA
27 participants
Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)
2015-04-28
Participant Flow
Recruited Dec. 2008-May 2012 for all phases. Participants were recruited from a Comprehensive Pain Clinic and through provider referral.
Participant milestones
| Measure |
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.
|
Phase 2
Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
|
Overall Study
COMPLETED
|
18
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
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.
|
Phase 2
Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
|
|---|---|---|
|
Overall Study
Withdrawal by PI
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment
Baseline characteristics by cohort
| Measure |
Phase 1
n=18 Participants
Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are.
|
Phase 2
n=6 Participants
Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 8.25 • n=5 Participants
|
56 years
STANDARD_DEVIATION 17 • n=7 Participants
|
55 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Pain Severity
|
6.33 units on a scale
STANDARD_DEVIATION 1.77 • n=5 Participants
|
5.88 units on a scale
STANDARD_DEVIATION 0.63 • n=7 Participants
|
6.21 units on a scale
STANDARD_DEVIATION 1.50 • n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)Population: Per protocol
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).
Outcome measures
| Measure |
Phase 1
n=18 Participants
Qualitative interviews
|
Phase 2
n=5 Participants
Pilot IVR-based CBT treatment
|
|---|---|---|
|
Comprehension
|
92.14 Percent of questions answered correctly
Standard Deviation 12.51
|
96.42 Percent of questions answered correctly
Standard Deviation 9.29
|
Adverse Events
Phase 1
Phase 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place