Trial Outcomes & Findings for Telehealth Outreach for Chronic Back Pain (NCT NCT00608530)
NCT ID: NCT00608530
Last Updated: 2018-02-19
Results Overview
The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.
COMPLETED
NA
127 participants
Baseline, End of Treatment (8 weeks)
2018-02-19
Participant Flow
In Study 1 (Psychologist-delivered treatment) recruitment commenced July 1, 2008 and concluded December 31, 2011. In Study 2 (Nurse- delivered treatment) recruitment commenced July 1, 2012 and concluded December 31, 2015. In both studies patients were recruited from VA clinics via flyers, by community newsprint advertisement, and by word of mouth.
In both Study 1 (Psychologist-delivered treatments, N = 66) and Study 2 (Nurse-delivered treatments, N = 67) participants who qualified and enrolled were randomized to their group assignment within 7-10 days of qualification.
Participant milestones
| Measure |
Cognitive Behavioral Therapy-Psychologist-Dellivered
10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
|
Supportive Psychotherapy-Psychologist-Delivered
10 hours of Rogerian Supportive Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Rogerian supportive psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach
|
Cognitive Behavioral Therapy-Nurse-Delivered
10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
|
Supportive Psychotherapy-Nurse-Delivered
10 hours of Supportive Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
|
|---|---|---|---|---|
|
Study 1 Psychologist-delivered Treatment
STARTED
|
33
|
33
|
0
|
0
|
|
Study 1 Psychologist-delivered Treatment
Attended > 0 Treatment Sessions
|
28
|
31
|
0
|
0
|
|
Study 1 Psychologist-delivered Treatment
COMPLETED
|
22
|
28
|
0
|
0
|
|
Study 1 Psychologist-delivered Treatment
NOT COMPLETED
|
11
|
5
|
0
|
0
|
|
Study 2 Nurse-delivered Treatments
STARTED
|
0
|
0
|
33
|
34
|
|
Study 2 Nurse-delivered Treatments
Attended > 0 Treatments
|
0
|
0
|
30
|
31
|
|
Study 2 Nurse-delivered Treatments
COMPLETED
|
0
|
0
|
21
|
27
|
|
Study 2 Nurse-delivered Treatments
NOT COMPLETED
|
0
|
0
|
12
|
7
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy-Psychologist-Dellivered
10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
|
Supportive Psychotherapy-Psychologist-Delivered
10 hours of Rogerian Supportive Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Rogerian supportive psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach
|
Cognitive Behavioral Therapy-Nurse-Delivered
10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
|
Supportive Psychotherapy-Nurse-Delivered
10 hours of Supportive Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
|
|---|---|---|---|---|
|
Study 1 Psychologist-delivered Treatment
Withdrawal by Subject
|
11
|
5
|
0
|
0
|
|
Study 2 Nurse-delivered Treatments
Withdrawal by Subject
|
0
|
0
|
3
|
3
|
|
Study 2 Nurse-delivered Treatments
Lack of Efficacy
|
0
|
0
|
2
|
3
|
|
Study 2 Nurse-delivered Treatments
Protocol Violation
|
0
|
0
|
2
|
0
|
|
Study 2 Nurse-delivered Treatments
Time demands of study
|
0
|
0
|
4
|
1
|
|
Study 2 Nurse-delivered Treatments
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Telehealth Outreach for Chronic Back Pain
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy-Psychologist-Delivered
n=33 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact by a psychologist
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=33 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact by a psychologist
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
Cognitive Behavioral Therapy-Nurse-Delivered
n=30 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact by a medical nurse
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Nurse-Delivered
n=31 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact by a medical nurse
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 12.5 • n=39 Participants
|
54.0 years
STANDARD_DEVIATION 14.8 • n=41 Participants
|
62.5 years
STANDARD_DEVIATION 11.3 • n=35 Participants
|
64.3 years
STANDARD_DEVIATION 12.7 • n=31 Participants
|
53.3 years
STANDARD_DEVIATION 13.6 • n=146 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
31 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
96 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=39 Participants
|
33 participants
n=41 Participants
|
30 participants
n=35 Participants
|
31 participants
n=31 Participants
|
59 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (8 weeks)Population: Per protocol population. All participants with baseline and Week 8 disability scores.
The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.
Outcome measures
| Measure |
Cognitive Behavioral Therapy Psychol-Delivered Treatment Study
n=33 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=33 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
|---|---|---|
|
Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study
Baseline Roland and Morris Disability
|
10.0 units on a scale
Standard Deviation 4.7
|
10.4 units on a scale
Standard Deviation 4.4
|
|
Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study
Week 8 Roland and Morris Disability
|
7.6 units on a scale
Standard Deviation 5.0
|
7.8 units on a scale
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment for Nurse-Delivered Treatment Study (8 weeks)Population: All randomized participants who attended at least 1 treatment session were analyzed, with multiple imputation used to address missing data.
The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.
Outcome measures
| Measure |
Cognitive Behavioral Therapy Psychol-Delivered Treatment Study
n=30 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=31 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
|---|---|---|
|
Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study
Baseline Roland and Morris Disability
|
11.4 units on a scale
Standard Deviation 5.9
|
11.1 units on a scale
Standard Deviation 5.4
|
|
Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study
Week 8 Roland and Morris Disability
|
9.4 units on a scale
Standard Deviation 6.1
|
9.1 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (8 weeks)Population: Intent-to-treat analysis of all randomized participants, using multiple imputation to address missing data.
The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from "0" to "1 0" where "0" indicates "no pain" and "10" indicates the "worst imaginable pain."
Outcome measures
| Measure |
Cognitive Behavioral Therapy Psychol-Delivered Treatment Study
n=33 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=33 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
|---|---|---|
|
Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study
Current Pain Intensity (0-10) at Baseline
|
5.0 units on a scale
Standard Deviation 1.8
|
5.5 units on a scale
Standard Deviation 1.6
|
|
Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study
Current Pain Intensity at Week 8
|
4.1 units on a scale
Standard Deviation 1.8
|
4.1 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment of Nurse-Delivered Treatment Study (8 weeks)Population: Modified intent-to-treat analysis of all randomized participants who attended 1 or more treatment visits; multiple imputation used to address missing data.
The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from "0" to "1 0" where "0" indicates "no pain" and "10" indicates the "worst imaginable pain."
Outcome measures
| Measure |
Cognitive Behavioral Therapy Psychol-Delivered Treatment Study
n=30 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=31 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
|---|---|---|
|
Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study
Current Pain Intensity (0-10) at Baseline
|
4.9 units on a scale
Standard Deviation 2.1
|
5.0 units on a scale
Standard Deviation 1.9
|
|
Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study
Current Pain Intensity at Week 8
|
4.0 units on a scale
Standard Deviation 1.9
|
3.8 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks)Population: Intent-to-treat analysis of all randomized participants; multiple imputation was used to address missing data.
Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as "Better," "Worse," or "About the Same." Participants then were asked to estimate the percentage of change (i.e., 0 to 100%). Participants rating themselves as "About the Same" were coded as "0%" change. The percentage of change was calculated for each Group as a whole (Cognitive Behavioral Therapy-Psychologist Delivered compared to Supportive Care Psychologist-Delivered).
Outcome measures
| Measure |
Cognitive Behavioral Therapy Psychol-Delivered Treatment Study
n=33 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=33 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
|---|---|---|
|
Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function
|
31 percent change
Standard Deviation 30.4
|
18.5 percent change
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks)Population: Modified intent-to-treat analysis of all participants who attended at least 1 treatment session
Participant self-rating of overall change compared to baseline, considering overall function and pain intensity, using a 7-point scale ranging from 'Very Much Worse' to 'Very Much Improved.' We compared the proportion of participants in each Group rating themselves as either 'Much Improved' or 'Very Much Improved.'
Outcome measures
| Measure |
Cognitive Behavioral Therapy Psychol-Delivered Treatment Study
n=30 Participants
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily).
|
Supportive Psychotherapy-Psychologist-Delivered
n=31 Participants
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach
|
|---|---|---|
|
Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved'
|
39 percentage of participants
|
27 percentage of participants
|
Adverse Events
Cognitive Behavioral Therapy-Psychologist-Delivered
Supportive Psychotherapy-Psychologist-Delivered
Cognitive Behavioral Therapy-Nurse-Delivered
Supportive Psychotherapy Nurse-Delivered
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joseph H. Atkinson MD, Principal Investigator
VA San Diego Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place