Automated Telephone as an Adjunct for the Treatment of

Automated Telephone as an Adjunct for the Treatment of
Chronic Pain: A Pilot Study
Magdalena R. Naylor,* John E. Helzer,* Shelly Naud,† and Francis J. Keefe‡
Abstract: The objective of this study was to test whether Interactive Voice Response (IVR) can be
used to enhance the therapeutic outcome of patients receiving group cognitive behavioral therapy
(CBT) for chronic pain. Ten subjects with chronic pain syndromes participated in 10 weeks of group
CBT followed by 4 months of Therapeutic Interactive Voice Response (TIVR). Our specially designed
TIVR is based on a computerized telephone system in which callers are asked questions and respond
by using the telephone keypad. It was created to reinforce pain coping skills and to provide messages
for relaxation, sleep induction, and emotional support that can be accessed by patients on demand.
Within-subject analysis showed that maximum positive change for nearly all outcome measures was
observed at the post-TIVR point. For some measures, improvement compared to baseline was
significant after TIVR despite the fact it had not been significant after CBT. Measures showing this
pattern included SF-36 Mental Health Composite Score (P < .0004), McGill Pain Questionnaire pain
(P < .01), Coping Strategies Questionnaire Catastrophizing (P < .0006), Treatment Outcomes in Pain
Survey Total Pain Experience (P < .03), and Perceived Family/Social Disability (P < .02). Our preliminary results suggest that TIVR can be used to improve coping skills adherence and to prevent relapse
into pain behavior.
© 2002 by the American Pain Society
Key words: Chronic pain, IVR, automated telephone, cognitive behavioral therapy.
C
hronic pain is a common and enormously debilitating condition. With the growing recognition of
the limitations of medical and surgical approaches, there is heightened interest in the role that
self-care and behavioral interventions can play in its
management.25
There is considerable evidence that a course of 8 to 12
weeks of group cognitive behavioral therapy (CBT) offers
significant therapeutic benefit to patients with chronic
pain. Many report a decrease in pain and improvement
in both physical and psychological disability.6,7,27,53 Patients learn and practice relaxation techniques, new coping
skills,
and
more
effective
interpersonal
skills.2,10,15,26,27,31 Often patients who are disabled by
their pain are able to return to work.13,34
The above findings are encouraging, but there is also
evidence of a decline in the use of the CBT skills over time
Received October 1, 2001; Revised March 22, 2002; Accepted March 22,
2002
From the *Department of Psychiatry, University of Vermont College of
Medicine, and †Department of Medical Biostatistics, University of Vermont, Burlington, VT, and the ‡Department of Psychiatry and Behavioral
Sciences, Duke University Medical School, Durham, NC.
Supported by a grant (M.R.N.) from the Pilot Project Awards Program of
the Office of Patient Oriented Research at UVM/Fletcher Allen Health
Care, Burlington, VT. Additional support was from AA 11954 from NIH/
NIAAA (J.E.H.).
Address reprint requests to Magdalena R. Naylor, MD, PhD, Departmentof Psychiatry, University of Vermont, 1 South Prospect Street, Burlington, VT 05401-3456. E-mail: [email protected]
© 2002 by the American Pain Society
1526-5900/2002 $35.00/0
doi:10.1054/jpai.2002.129563
and difficulty maintaining treatment gains.6,34,52 Patients who initially improve after CBT but fail thereafter
can become even more pessimistic and entrenched in
their maladaptive behaviors. They can become depressed, fearful, and preoccupied with their physical
complaints, which further perpetuates chronic pain disability.11,32 Initial gains in work performance and job
retention may decline over time.34
During the typical history of several years of chronic
pain, many patients develop response habits that help
perpetuate the pain. Such habits are not changed suddenly but require gradual replacement with more appropriate patterns of response. When this is done, it is more
likely that the former maladaptive behavior will be extinguished. Given this typical history, a behavioral treatment program of 8 to 12 weekly group sessions is remarkably short. However, when CBT is successful, a
major step is taken by patients toward recognizing and
eliminating habitual maladaptive behavioral responses
to pain and substituting more adaptive ones. If patients
continue to use the skills they have learned, the new
behaviors are strengthened and the therapeutic effect
increases.42,43 However, the transition from initially
learning skills under the guidance of a therapist to maintaining those skills on one’s own can be difficult.
Given the advantages of group CBT (including low cost
and minimal side effects) and its demonstrated efficacy,30,31 it would be desirable to find ways of promoting
the maintenance of initial treatment gains. An automated technology that offers such potential is Interac-
The Journal of Pain, Vol 3, No 6 (December), 2002: pp 429-438
429
430
tive Voice Response (IVR). Interactive Voice Response is
essentially a method for interaction between an individual and a computer through the medium of a telephone.
A toll-free number connects the user to the IVR, a recorded voice asks scripted questions following a branching logic format, and the caller inputs responses by using
the telephone keypad.
Automated Technologies
During the past decade there has been considerable
growth in automated (computer mediated) technologies
for assessment and treatment. In part this is a response to
the dramatic expansion of and general familiarity with
personal computers during the past few years.9,21 Many
options are available including desktop computers,
palmtops, IVR, interactive televideo, and even wearable
devices such as the Transdermal Alcohol Sensor.51 Automated technologies for assessment and treatment offer
many potential advantages. For the patient these include 24-hour accessibility, the convenience of remote
access, and a high level of comfort in reporting even
sensitive material.9,33 Caregiver/investigator advantages
include reduced cost of data collection, greater standardization of clinical information, a high level of data
validity due to patient comfort in reporting candidly,33
and immediate access to data for analysis. In addition,
electronic data collection offers particular advantages
for monitoring clinical variables on a daily basis. Jamison
et al18 used palmtops for daily monitoring of pain. They
found that patients preferred the electronic format and
showed much higher rates of compliance and satisfaction during a 1-year trial.
For clinical assessment, several well-known rating
scales are available for computer administration. These
include the Hamilton Depression Rating Scale,1 the Hamilton Anxiety Scale,33 the Liebowitz Social Anxiety
Scale,24 the Yale-Brown OCD Scale,3 the Clinical Interview Schedule,36 and the Addiction Severity Index.9 Recently Mundt et al40 have published an IVR-based tool
for dementia screening. The latter was developed by the
group at Healthcare Technology Systems, a clinical research and technology company specializing in clinical
IVR systems for the pharmaceutical and health care industries that are available commercially.
In the area of treatment, automation has been particularly popular in substance cessation programs. Automated technologies have been used to enhance personal
confidence,12 to deal with setbacks and to maintain momentum,16 to increase comfort in disclosing information,46 and to ascertain real-time data on the role of
environmental cues in relapse.50 To better understand
the points at which intervention might be optimal, Shiffman et al49 used palmtop computers to examine the situational association between drinking and smoking.
Schneider et al47 programmed a computer to interact
directly with callers via the touch-tone telephone in a
smoking cessation program. The system automatically
composed messages to fit the needs, expectations, and
progress of each caller and interacted at the preparation,
Automated Telephone for Chronic Pain Treatment
quitting, or maintenance stage as appropriate. Intervention trials have also been published for IVR-assisted
treatment of obsessive-compulsive disorder4 and major
depression.41
In this study, we tested whether an IVR-based intervention we developed called Therapeutic Interactive Voice
Response (TIVR) could increase treatment compliance
and adherence in chronic pain patients and improve outcome at follow-up. The TIVR (see Methods for a description) was designed to enhance group CBT by providing
automated access to self-monitoring, didactic review of
coping skills, guided behavioral rehearsal of skills including prompts for regular practice, and personalized encouragement and reinforcement. To our knowledge, this
trial is the first attempt at using automated technology
for intervention in chronic pain. Although not specifically tested in this study, TIVR shares with other automated technologies the potential of reducing health
care utilization costs.
Materials and Methods
Subject Recruitment and Screening
Procedure
The University of Vermont Institutional Review Board
approved the research protocol, and informed consent
was obtained from each subject. Subjects for this study
were a consecutive sample of patients referred to the
MindBody Medicine Clinic (MBMC) at the university medical center during the period of study. In general, referrals are made by specialists from the university Pain Management Clinic, rheumatologists, primary care and other
physicians. The eligible population for this study were
those referred for treatment of chronic, non-neuropathic pain who met the following inclusion/exclusion
criteria.
Inclusion Criteria
These criteria included at least 6 months of musculoskeletal or other non-neuropathic pain such as back pain,
osteoarthitis, or headaches; ongoing standard pain management (typically involving oral medication and physical therapy, with or without anesthetic or steroid injections); age 18 years or older; and a touch-tone phone in
the home.
Exclusion Criteria
These criteria included a diagnosis of severe personality disorder or any psychotic disorder; patients awaiting a
pain-related surgical procedure or involved in pain-related litigation. We did not exclude patients with painrelated disability but did exclude those involved in pursuing settlement of a disability claim, because this or
pain-related litigation might influence their perception
or reports of pain sensitivity.
The overall study design is illustrated in Fig 1. The recruitment protocol was as follows. The psychiatrist or a
staff psychologist contacted each MBMC referral by
phone to explain the pain management program and to
ORIGINAL REPORTS/Naylor et al
431
determine the patient’s interest in CBT group participation. Initial assessment questionnaires (listed below)
were sent, followed by an initial in-person evaluation
with the psychiatrist or a staff psychologist.
There were 13 eligible subjects, 11 of whom agreed to
enroll in the study. Enrollees were all white, 10 were
women, and the mean age was 47 years. All 11 subjects
finished the 10 weeks of group CBT and completed the
subsequent 4 months of TIVR. One subject did not return
the last follow-up evaluation questionnaire and thus was
dropped from the analysis. The demographic characteristics of the 10 remaining study subjects appear in Table
1. Table 2 shows baseline values in this sample compared
to selected normative values.
Interventions
Group Behavioral/Cognitive Therapy
Cognitive behavioral therapy was delivered in ten, 90minute weekly group sessions. The treatment model was
based on the gate control model of pain as a complex
experience affected by thoughts, feelings, and behaviors
by Melzack and Wall.39 The CBT intervention for pain
management was designed to (1) change cognition and
decrease maladaptive catastrophizing, (2) enhance patients’ ability to use attention diversion, and (3) change
activity patterns to better control pain.
Below are the 5 treatment areas emphasized in our
program and the associated cognitive-behavioral interventions to achieve the goals described above.
Table 1.
Figure 1. Study design.
Sample Characteristics
PAIN
SUBJECT
NO.
AGE
(YR)
MARITAL
SEX
STATUS
EDUCATION
(YR)
DURATION
OCCUPATION
(YR)
DIAGNOSES
6
S/P neck, shoulder
injury
Neck, shoulder, low
back
Fibromyalgia,
interstitial cystitis
Fibromyalgia, leg,
hands, muscle pain
Fibromyalgia, HAs,
abdominal pain
Repetitive motion
injury (shoulder,
hand)
Tension and migraine
headaches
Foot pain secondary
to sprained ankle
Headaches
Low back pain of
unknown etiology
1
39
F
M
12
Disabled
2
50
M
M
13
FT, logging
3
42
F
S
13
FT, office manager
4
43
F
M
14
FT, RN
13
5
53
F
M
12
Disabled
20
6
61
F
M
14
Disabled
5
7
34
F
S
16
FT, marketing
8
43
F
M
20
FT, teacher
9
10
52
50
F
F
M
M
16
12
FT, RN
Disabled
Mean,
N ⫽ 10
SD
46.7
14.2
11.2
7.5
2.4
9.1
S/P, status post; FT, full time; HAs, headaches; SD, standard deviation.
20
3
12
1
30
2
432
Automated Telephone for Chronic Pain Treatment
Table 2.
Normative Values and Sample Means for the Key Study Variables
NORMATIVE
MEAN
MEAN
MEAN
(SD)
BASELINE
(SD)
(N ⫽ 10)
72.0
63.4
62.1
74.9 (18.6)
66.3 (28.6)
15.6 (9.4)
2.5 (1.2)
2.8 (1.4)
70.0 (13.4)
50.1 (13.9)
42.6 (14.5)
42.2 (11.9)
33.7 (9.4)
15.7 (7.5)
2.8 (1.3)
2.3 (1.8)
62.4 (14.7)
46.8 (14.3)
38.4 (15.7)
44.7 (12.7)
34.6 (9.4)
7.2 (6.9)
3.7 (1.1)
3.3 (0.9)
62.8 (7.4)
43.7 (11.8)
34.2 (12.7)
48.4 (10.1)
35.8 (8.9)
6.4 (7.6)
3.4 (0.8)
3.5 (1.3)
VALUES
KEY
STUDY VARIABLES
TOPS Pain Symptom
TOPS Total Pain Experience
TOPS Perceived Social Disability
SF-36 Mental Composite
SF-36 Physical Composite
CSQ Catastrophize
CSQ Ability to Control Pain
CSQ Ability to Decrease Pain
MEAN
POST CBT
(SD)
(N ⫽ 10)
POST TIVR
(SD)
(N ⫽ 10)
TOPS Normative Values are for the pain clinic patients.44
SF-36 Normative Values are for the general population.54
CSQ Normative Values are for the pain clinic patients (F. Keefe, personal communication).
Relaxation Techniques and Cognitive Coping
Strategies. Although there is no definitive list of
adaptive coping strategies, there is an agreement that
relaxation techniques,22,23 cognitive restructuring, and
diverting attention29 are helpful in dealing with chronic
pain. On the other hand, catastrophizing and other negative thoughts have been shown to be maladaptive coping strategies28 and need to be challenged to achieve
improvement. Because catastrophizing is an automatic,
reflexive process, patients do not recognize it but are
only aware that their mood drifts downward and pain
level rises. Thus, a therapeutic goal we emphasized was
to help the patient recognize catastrophizing, to challenge negative thoughts, and to replace them with positive self-statements. In addition to cognitive restructuring and problem solving techniques, we taught other
adaptive coping skills such as communication skills, cognitive distractions, activity pacing, and a variety of relaxation techniques (progressive relaxation, autogenic
training, meditation, and guided imagery). During the
program, therapists demonstrated examples of each
coping strategy and guided patients in trying them out.
Patients were then encouraged to practice each strategy
as homework assignments. Audiocassette tapes were
given to each patient to practice relaxation techniques at
home daily.
Challenging Pain Beliefs. Patients’ understanding
of or beliefs about their pain influence their motivation
to engage in behavioral tasks and pain treatment modalities.19,20 In our program we used a variety of techniques
to change maladaptive pain beliefs and to improve feelings of patient self-efficacy. These included cognitive distraction, relaxation techniques, and time-contingent behavioral pacing skills. We also encouraged patients to
work on increasing pleasant activities, social opportunities, and feelings of self-worth.
Setting Treatment Goals. At the beginning of CBT
program we explained the necessity of all patients deciding on a set of specific treatment goals. Patients set their
own goals with our guidance so that they were realistic
but challenging. At the end of the group CBT program,
patients reviewed their goals and possible obstacles in
maintaining them.
Pain Diaries as a Self-Education Tool. Patients
were encouraged to keep a paper and pencil daily pain
diary during the 10 weeks of CBT. Pain diaries enabled
the therapists to monitor treatment progress and provided a tool for patient self-education. Patients were
taught to recognize connections between their life
events and the daily fluctuations in their pain. Use of the
patient’s own self-reported information helped to emphasize the importance of cognitive appraisal and emotion. Pain diaries also showed the relationship of overexertion or underexertion and exacerbation of pain.
Enhancing Social Support. Spouses or significant
others were invited to attend the week-eight session. In
this study, 8 of the 10 partners attended. The purpose of
this was to educate partners about the program, to provide the opportunity for them to ask questions, to obtain
collateral feedback regarding patients’ progress, and to
share their experiences with the other patients and partners. Social learning theory suggests that changes in behavior and thoughts can result from observing models in
the world around us, such as peers or family members.5,8
We believe that this “Social Support” session helps shift
the frame of thinking so as to generalize from the group
to other important aspects of life (eg, the partner). It
facilitates the process of associating the group with an
important person from the outside of group. We think
that this session also deepens patients’ own emotional
experience, which may also promote a longer-lasting influence.
TIVR
The TIVR is based on a computer-driven system in
which a prerecorded human voice asks a series of questions and callers respond by using the telephone keypad.
The dedicated, toll-free phone number is active throughout the continental United States and Canada so calls can
be made when traveling, while on vacation, or even if
the subject moves out of the area. We created the TIVR as
ORIGINAL REPORTS/Naylor et al
an extension of CBT group therapy elements that utilize
a relapse prevention model of behavior change.17 The
TIVR has 4 components.
Component 1 (self-monitoring) is a 21-item daily questionnaire. Subjects are asked to rate for the previous 24
hours their level of pain, mood, stress, use of pain medication, and a variety of other parameters. This daily selfmonitoring provides a convenient means of reporting
not only symptoms but also target behaviors, frequency
of use of coping skills, and coping efficacy.
For this pilot study we suggested completing the Component 1 questionnaire daily, but to see what the spontaneous call frequency would be, we did not make this a
condition of study participation. Patient calls were monitored, and reminder calls were made only during the
first week of the study, as we have done in previous
work.48 To compensate for their time, subjects were paid
$0.70 for each day they called the daily questionnaire.
The daily questionnaire could be answered only once
every 24 hours. After participants completed the daily
self-monitoring component of TIVR, they could branch
to one of the other components or make separate calls
for the other components as often as they liked.
Component 2 (didactic skills review) permits patients
to access a verbal review of 8 different pain management
skills learned during the 10 weeks of CBT, such as reappraisal of pain, activity pacing, cognitive restructuring,
relaxation response, self-talk, and others. Each review is
1 to 4 minutes in length. Having ongoing access to the
rationale for and instruction in pain coping skills can be
useful in enhancing patients’ understanding of these
techniques. As emphasized in the relapse prevention
model,17,32 access to didactic review of such coping strategies is particularly useful in reminding patients that
they have multiple options for coping with pain.
Component 3 (guided behavioral rehearsal of pain
coping skills) is a set of eight 2- to 10-minute verbal messages for relaxation, sleep induction, cognitive restructuring, and other skills. The therapist verbally guides the
patient through the pain coping skills they had previously learned during the group CBT. Patients are encouraged to use this component to reinforce their practice
efforts and to help them deal with challenging situations
(eg, pain flares, emotionally or physically demanding life
events) that might lead to coping setbacks. In the relapse
prevention model, guided behavioral rehearsal is especially useful in enhancing the patient’s sense of self-efficacy in learned coping skills.32,37
Component 4 (monthly therapist feedback) of the TIVR
intervention is a personalized message from the group
therapist recorded once a month for each subject summarizing progress and offering suggestions. This message contains a summary of the patient’s daily reports to
the TIVR for the past month; insight into possible relationships between reported pain, stress, mood, anger,
and use of coping skills; suggestions for other pain management tactics; and verbal encouragement. This regular
feedback also simulates and extends the weekly feedback provided during the initial CBT training. The relapse
prevention model maintains that periodic therapist
433
feedback is quite useful in helping patients to gauge
their progress and to recognize successes as well as problems in coping with challenging situations.37
All subjects participated in a 90-minute group TIVR
training session for which they were reimbursed $20.
This session was held 1 week before the end of CBT
group program so that patients had an opportunity to
practice using the TIVR before finishing CBT and to ask
any questions before starting the 4-month TIVR trial.
Each subject was given a detailed but user-friendly instruction manual. Subjects were assigned a unique identification number and selected their own numeric password to ensure security of their personal data.
Calls for the 4-month TIVR trial began the day after
training; however, the first post-CBT week was designated for system practice, and the data for that week
were not analyzed. If a subject missed a daily TIVR call on
2 successive days during this first week, we called them to
inquire about any difficulties. There were no call reminders after the first week of the TIVR trial. The computer
was programmed to monitor patient calling records, and
then daily reports were generated for the therapist’s
monthly message.
Assessment Instruments/Questionnaires
Intake Assessment Questionnaire
This is a general information questionnaire created for
the MBMC to obtain demographic data including sex,
age, marital status, occupation, employment status, and
educational level. In addition, a history of the patient’s
pain and related treatment, health perception and habits, roles and relationships, coping skills, and other areas
are explored. This questionnaire was completed only at
the time of initial enrollment. No psychometric data are
available for this instrument.
All participants were asked to complete the following
self-report instruments at the time of enrolment and at
the 2 follow-up evaluations.
Augmented SF-36 (Treatment Outcomes in
Pain Survey — TOPS)
The SF-36 was originally developed for the Medical
Outcomes Study as a general instrument to evaluate
health status in broad range of medical populations.54
Although brief, the SF-36 has considerable normative
data and has been validated worldwide.14 The augmented version of SF-36 for pain (TOPS) is a 120-item,
pain-enhanced version of the SF-36 that includes measures of 11 dimensions of pain and pain treatment response.44,45 The most comprehensive of these, the TOPS
Total Pain Experience Scale, is a sum of 5 TOPS subscales:
Pain Symptom, Functional Limitations, Perceived Family
Disability, Objective Family Disability, and Objective
Work Disability.45 TOPS Total Pain Experience is the scale
that best discriminated individual changes within the
populations used to norm the TOPS.45
434
McGill Pain Questionnaire (MPQ—Short
Form)38
Participants completed the short form of the MPQ, a
structured instrument to assess quantitative and qualitative aspects of pain including location, quality, intensity,
and temporal properties. In this study we present the
results of 2 items drawn from MPQ: (1) level of pain right
now and (2) typical level of pain. Participants rate the
items by using a 10-point scale.
Coping Strategies Questionnaire (CSQ)35
CSQ is a 50-item questionnaire scored on a visual analog scale to assess the frequency of use and the success of
various coping skills and strategies that patients might
use in responding to chronic pain. In this study we
present the CSQ subscale assessing the level of catastrophizing and the 2 ratings of coping strategy effectiveness: (1) to control pain and (2) the perceived ability
to decrease pain. Participants rated both items by using a
7-point scale.
Structured Patient Feedback
At the conclusion of the study, all patients were sent a
questionnaire about their experience. They were asked
what they liked and disliked about the TIVR and to suggest ideas for improvements. This was followed by a
face-to-face interview in the office in which they could
expand on these personal impressions.
Data Analysis
Results for each of the above instruments were analyzed separately by using repeated measures analysis of
variance. The more conservative Huyn-Feldt adjusted F
test was used rather than the usual F test to compensate
for moderate violations of the underlying assumptions.
Results
The results are presented in 2 sections. The first section
reports on the feasibility of the TIVR in patients with
chronic pain syndromes; the second presents the outcome data on 10 subjects who completed the 10 weeks of
group CBT, the 4 months of TIVR, and returned final
evaluation questionnaires.
Subjects’ Use of the TIVR (Feasibility)
All patients made regular use of the TIVR throughout
the 4 months of study. Collectively the 10 research subjects called the daily self-monitoring questionnaire
(Component 1) on 83% of the approximately 1200 reporting days. This mean was reduced by 1 subject who
made only 45% of the daily calls. The daily calling rates
of the remaining 9 subjects ranged from 70% to 99%,
with a mean of 87%. There was a slight decline in the
percentage of daily calls during the 4 months. On the
other hand, 9 of the 10 subjects made 107 unremunerated calls (69% by 2 subjects) after the end of the study.
The didactic review of skills (Component 2) was variably used. Seven of 10 subjects used this component at
Automated Telephone for Chronic Pain Treatment
least once. The group’s average frequency of use was 1.5
times a week across the 4-month trial. The highest level
of use occurred in months 1 and 4 with a relative hiatus in
months 2 and 3.
The guided behavioral rehearsals (Component 3) were
used by all 10 of the subjects. Use by individual subjects
ranged widely from a low of 3 times across the 4 months
to a high of 83 times, ie, more than 5 times a week. Mean
usage across the 10 subjects was more than once a week,
and use was more consistent across the 4 months than it
was for component 2. The most popular behavioral rehearsals were Body Scan Relaxation and Sleep Induction.
Every subject reviewed each new monthly therapist
feedback message (Component 4) as soon as it was available. Many reviewed each monthly message more than
once, and some even requested a hard copy.
Finally, we asked subjects to fill out a questionnaire
about the TIVR at the conclusion of the study. These
results indicated that all subjects found the TIVR to be
helpful in a variety of ways. Most patients believed that
the TIVR reinforced what they learned in the CBT group
program. They reported that the TIVR enhanced their
motivation to continue practicing the new skills they
learned and provided structure so learned skills became
a habit. We concluded that the 4-month duration of the
TIVR was a reasonable length of follow-up to ensure
patients are maintaining learned patterns, but not so
long as to be burdensome to the patients or the clinician.
Only one patient thought that 4 months of calling was
too long; the others continued to call after the 4-month
trial. One resumed calling 2 months after the trial ended
during increased family stress associated with an increase of pain.
Treatment Outcomes After CBT and After
TIVR
This was a single group study in which patients’
progress after treatment and after TIVR was compared
independently to their pretreatment baseline. Therefore, we analyzed the outcome data by using withinsubject analyses.
Table 2 shows sample means for key study variables
compared to baseline and normative values. The treatment outcome results summarized in Table 3 present
variables from the SF-36, MPQ, and TOPS and 3 variables
from the CSQ. Our minimum criterion for therapeutic
success was that improvements obtained during CBT
would be maintained during the 4 months of TIVR. However, for Mental Health Composite Score from TOPS and
most of the pain measures, results were actually more
positive than that; improvements continued to
strengthen during the TIVR trial, ie, after CBT had been
completed. For example as shown in Table 3, the maximum mean change from baseline for all reported measures except one CSQ variable (Ability to Decrease Pain)
occurred at the post-TIVR point. For 3 measures, improvement compared to baseline was statistically significant at the post-TIVR point despite the lack of significance at the post-CBT point. These latter included the
ORIGINAL REPORTS/Naylor et al
Table 3.
435
Maximum Mean Changes and P Values for Assessment Scales at Baseline, Post CBT, and Post TIVR
CONTRASTS TO
(P VALUE)
BASELINE
OVERALL
MAXIMUM
MEAN
TEST
CHANGE*
SF-36 Mental Health Composite (⫹)†
SF-36 Physical Composite Score (⫹)
MPQ - Pain Now (⫺)
MPQ - Pain Typical (⫺)
CSQ - Catastrophizing (⫺)
CSQ - Ability to Control Pain (⫹)
CSQ - Ability to Decrease Pain (⫹)
TOPS - Total Pain Experience(⫺)
6.2 (2)
2.1 (2)
⫺1.20 (2)
⫺.80 (2)
⫺9.3 (2)
0.90 (1)
1.20 (2)
⫺6.5 (2)
TEST
(P VALUE)
.04
NS
.02
NS
.0001
.01
.01
.01
POST
CBT
NS
—
NS
—
.0005
.01
.04
NS
POST
TIVR
.0004
—
.01
—
.0006
.08
.01
.03
N ⫽ 10 subjects. Huyn-Feldt Adjusted F Test was used for these analyses.
CBT, cognitive behavioral therapy; TIVR, Therapeutic Interactive Voice Response; NS, not significant.
*Number in parentheses indicates maximum change from baseline: 1, post CBT; 2, post TIVR.
†Sign in parentheses indicates the direction test results should go to satisfy expected outcome.
SF-36 Mental Health Composite score, the current pain
measure Pain Now on the MPQ, and the Total Pain Experience measure from the TOPS. Of the 22 variables we
reviewed from these 4 instruments, the only variable
that was significantly improved after CBT but no longer
significant after TIVR was the CSQ measure Praying or
Hoping, a so-called “negative” coping skill.
Two of the figures show the actual test scores at each
assessment for key variables from Table 3. In Fig 2, we
have shown 2 additional TOPS variables along with Total
Pain Experience. Fig 3 illustrates the two SF-36 summary
variables along with Catastrophizing scale from CSQ.
signs of setbacks in coping efforts, evaluate the effects of
specific coping skills, and become aware of successes and
problems in dealing with setbacks.32,37 In addition, pain
diaries (Component 1) enabled the therapists to monitor
treatment progress and to teach patients to recognize
connections between their life events and the daily fluctuations in their pain. Use of the patient’s own self-reported information helped to emphasize the importance
Discussion
In this small, within group, uncontrolled study, musculoskeletal pain patients who averaged 11 years of chronicity demonstrated statistically significant improvement in SF-36 Mental Health Composite, TOPS Total Pain
Experience, CSQ Catastrophizing, and CSQ Ability to Decrease the Pain after receiving 4 months of a telephonebased treatment specifically designed for chronic pain.
Although the treatment effect cannot be measured in
the absence of a control group, it seems that the TIVR
technology offers an option for self-directed treatment
as an adjunct to behavioral group therapy to sustain
some chronic pain patients.
On the basis of consistency of patient use and their
uniformly positive feedback, the feasibility of TIVR appears to be high. Subjects used the daily questionnaire
(Component 1, self-monitoring) nearly every day
throughout the 4-month trial. Participants were paid
$0.70 for each of these daily calls, but in retrospect the
payment was probably unnecessary. Half of the subjects
refused payment, and 9 of the 10 continued to call after
the end of the trial when there was no payment.
Self-monitoring is believed to be one of the most important components of maintenance enhancement.37
Relapse prevention models emphasize the utility of selfmonitoring in helping patients identify early warning
Figure 2. Actual test scores on 3 TOPS measures in patients with
chronic pain: (1) before starting 10 weeks of group CBT for pain
management (Baseline), (2) after completing the 10 weeks of
group therapy (Post CBT), and (3) after 4 additional months of
an automated telephone intervention (Post TIVR). All P values
are for comparisons to baseline.
436
Figure 3. Results from the Catastrophizing subscale of the CSQ
and 2 composite subscales from the SF-36 in patients with
chronic pain: (1) before starting 10 weeks of group CBT for pain
management (Baseline), (2) after completing the 10 weeks of
group therapy (Post CBT), and (3) after 4 additional months of
an automated telephone intervention (Post TIVR). All P values
are for comparisons to baseline. NS, Not significant.
of cognitive appraisal and emotion and the relationship
of overexertion or underexertion and exacerbation of
pain. We believe that this daily self-monitoring was one
of the contributing factors in improvement of symptoms.
However, the TIVR is more of an interactive process than
just keeping a self-monitoring calendar. Simply by doing
the questionnaire (Component 1), patients get a daily
reminder of the adaptive coping skills they have been
taught in CBT. Beyond that, extending self-monitoring
for 4 months helps patients generalize coping skills training from a group setting to daily life (confirmed by the
results of TOPS and SF-36) and enables patients to practice under expert guidance skills that they have not yet
mastered during the formal CBT program.
The didactic review of skills (Component 2) was used
least frequently, but most use was in the first month.
Presumably use rates fell after that as patients perfected
the skills they had learned in CBT. There was some increased use again in the fourth month, after reminders in
the third monthly message to subjects who had narrowed their skills repertoire. Components 3 and 4 were
used regularly throughout the 4 months by all of the
subjects. Patient feedback about the monthly message
suggests that it was an especially important part of the
TIVR. Patients appreciated the fact that it was personalized and recorded in the voice of the group therapist.
Automated Telephone for Chronic Pain Treatment
They believed this demonstrated the ongoing interest of
the therapist in their progress. We speculate that this
belief increased their motivation to use the TIVR as a
guide for their self-improvement.
Regarding the outcome data, for all the variables we
examined except one (Ability to Control Pain), the maximum change from baseline occurred after the 4 months
of TIVR rather than after the 10 weeks of CBT (Table 3).
The fact that key variables continued to show improvement and that these improvements were often statistically significant despite a sample size of only 10 patients
is also an encouraging preliminary outcome. This contrasts with the expected post-CBT outcome pattern for
patients having persistent pain, ie, a plateau in therapeutic benefit after CBT is completed and sometimes a
deterioration in improvement within a few months. We
believe that coping strategies are skills that need to be
practiced over time to be mastered. At the end of the
group CBT, patients had learned about coping skills but
had little experience in using them. The following 4
months of TIVR gave them opportunity to practice these
skills daily so they became a helpful habit rather than just
knowledge. We speculate that, when adherence to coping skills increases, the self-efficacy improves and relapse
into pain behaviors decreases. However, without a control group we cannot rule out regression to the mean as
an explanation for these findings. Patients may have
been referred for CBT (and thus recruited for the study)
at a time when their pain was above average in severity.
Gradual improvement back to their own mean level of
severity over time might then be interpreted as response
to the therapy. We believe this is unlikely for 3 reasons.
First is the magnitude of the improvement. Second is the
fact that improvement continued for an extended period of time and actually strengthened as time went on.
Third, spontaneous improvement was unlikely in this
group because all of the subjects had long histories of
pain and failure to respond to numerous prior trials of
treatment. Two other possible explanations that we cannot rule out are (1) that the improvement we found is
simply a manifestation of the fluctuations that are a part
of the natural history of chronic pain and (2) a placebo
effect, perhaps because of the near daily attention to the
study protocol. The lack of a control group is mitigated
to some extent by our use of within-subject analyses, in
which each subject serves as his/her own control. This
helps to minimize confounding by personality or other
variables that may influence outcomes.
To our knowledge, no similar automated telephonebased intervention has been described in the pain literature. A significant advantage of this technology is that
it facilitates self-directed management of chronic illness.
For example, 1 subject who stopped using the TIVR at the
conclusion of the trial resumed regular calling again a
few weeks later when she began to lose control of her
pain. She reported that this resumption helped greatly in
regaining a sense of behavioral control and a reduction
in pain symptoms.
Although these results appear promising, it is important to recognize the results are preliminary. Several lim-
ORIGINAL REPORTS/Naylor et al
itations of this study should be considered. First, although we had specific inclusion and exclusion criteria,
the study group was heterogeneous as to the cause of
the chronic pain. Consequently, it is unclear to what extent our results are generalizable to the treatment of
patients with other pain disorders and to other clinical
settings. Furthermore, the size of the study group was
small. Clearly, additional studies are needed to validate
our results.
We are cautiously optimistic about this technology at
this point. We continue to explore the therapeutic potential of the TIVR and hope to mount a randomized
controlled trial of TIVR in a group of patients with a
specific disorder, chronic knee pain due to osteoarthritis,
in the near future. We also plan to explore the relative
contribution of each component to the positive out-
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