Pain
Conditions
Keywords
cognitive behavioral therapy, pain
Brief summary
The purpose of this study is to determine whether telephone-delivered cognitive behavior therapy is effective in the treatment of chronic pain. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka.
Detailed description
Chronic pain represents an epidemic in the United States and a serious public health problem, particularly among adults over the age of 55. In the Veterans Health Administration (VHA), nearly 50% of patients seen in primary care settings report disabling pain symptoms. Persistent pain in older adults is often associated with disability, emotional distress, and increased health care utilization and cost. Since an increase in the number of older adults is anticipated over the next two decades, the problem of chronic pain in this age group will take on increased importance. Although cognitive behavior therapy (CBT) aimed at improving coping skills is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka. In Study Arm 1, patients received telephone-based cognitive behavior therapy (T-CBT); and in Study Arm 2, patients received pain education (T-ED) matched with Study Arm 1 for amount of contact time. Patients in both groups received 12 sessions of telephone-based individual therapy over a 20-week period. Pain management outcomes were measured at mid-treatment (10 weeks), post-treatment (20 weeks), and at 3-month (32 weeks) and 6-month (46 weeks) follow-up. Outcome variables included measures of pain symptoms, physical limitations, coping, emotional distress, and health-related quality of life. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain
Interventions
BEHAVIORALTelephone-delivered Cognitive Behavior Therapy
Telephone-delivered cognitive behavior therapy for pain management
OTHERTelephone-delivered Patient Education
Telephone-delivered patient education regarding chronic pain
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Potential subjects must be: * veterans enrolled in a VA primary care clinic * at least 55 years of age * have access to a telephone * have documented pain for at least the past year * a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction * Their pain condition must be stable and participants must have no clear indication for specific medical/surgical intervention.
Exclusion criteria
Patients were excluded who were: * psychotic * cognitively impaired * show significant suicidal risk (history of multiple suicide attempts or actively suicidal) * currently abusing alcohol or other drugs, including prescribed opioid pain medications * voice impairment that would prevent participation in telephone counseling * visual impairment that would prevent use of the workbook and completion of assessment materials. * Patients will also be excluded who have an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-12 Physical Health | 46 weeks | Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores |
| Short Form-12 Mental Health | 46 weeks | Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI)-2 Total Score | 46 weeks | Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression |
| Pain Behavior Checklist Total Score | 46 weeks | Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior |
| Pain Intensity Rating | 46 weeks | Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Telephone-delivered cognitive behavior therapy for pain management
Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management | 48 |
| Arm 2 Telephone-delivered patient education regarding management of chronic pain
Pain Education: Telephone-delivered education regarding chronic pain | 50 |
| Total | 98 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 9 | 69 years STANDARD_DEVIATION 10 | 67.5 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 49 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 46 Participants | 48 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 50 |
| serious Total, serious adverse events | 0 / 48 | 0 / 50 |
Outcome results
Primary
Short Form-12 Mental Health
Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores
Time frame: 46 weeks
Population: Veterans with chronic pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Telephone CBT | Short Form-12 Mental Health | 45 units on a scale | Standard Deviation 9 |
| Arm 2: Telephone Patient Education | Short Form-12 Mental Health | 46 units on a scale | Standard Deviation 10 |
p-value: <0.74Mixed Models Analysis
Primary
Short Form-12 Physical Health
Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores
Time frame: 46 weeks
Population: Veterans with chronic pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Telephone CBT | Short Form-12 Physical Health | 44 units on a scale | Standard Deviation 9 |
| Arm 2: Telephone Patient Education | Short Form-12 Physical Health | 41 units on a scale | Standard Deviation 9 |
p-value: <0.27Mixed Models Analysis
Secondary
Beck Depression Inventory (BDI)-2 Total Score
Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression
Time frame: 46 weeks
Population: Veterans with chronic pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Telephone CBT | Beck Depression Inventory (BDI)-2 Total Score | 16 units on a scale | Standard Deviation 11 |
| Arm 2: Telephone Patient Education | Beck Depression Inventory (BDI)-2 Total Score | 17 units on a scale | Standard Deviation 10 |
p-value: <0.35Mixed Models Analysis
Secondary
Pain Behavior Checklist Total Score
Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior
Time frame: 46 weeks
Population: Veterans with chronic pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Telephone CBT | Pain Behavior Checklist Total Score | 2.3 units on a scale | Standard Deviation 1.3 |
| Arm 2: Telephone Patient Education | Pain Behavior Checklist Total Score | 2.4 units on a scale | Standard Deviation 1.3 |
p-value: 0.39Mixed Models Analysis
Secondary
Pain Intensity Rating
Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain
Time frame: 46 weeks
Population: Veterans with chronic pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Telephone CBT | Pain Intensity Rating | 3.6 units on a scale | Standard Deviation 1.3 |
| Arm 2: Telephone Patient Education | Pain Intensity Rating | 3.4 units on a scale | Standard Deviation 1.3 |
p-value: 0.67Mixed Models Analysis