Chronic Pain
Conditions
Keywords
pain, chronic pain, cognitive therapy, telehealth
Brief summary
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Detailed description
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) 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. Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics. Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain. Major hypothesis: Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU). Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain. Secondary hypothesis: Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain. Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain. To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Interventions
BEHAVIORALTelephone cognitive behavior therapy
Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
BEHAVIORALTelephone pain education
Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, potential subjects must have: * access to a telephone * documented pain for at least the past year * a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction * pain condition must be stable * must have no clear indication for specific medical/surgical intervention.
Exclusion criteria
Patients were excluded who were: * acutely psychotic * cognitively impaired * showed significant suicidal risk (history of multiple suicide attempts or actively suicidal) * currently abusing alcohol or other drugs, including prescribed opioid pain medications * patients were also excluded who had an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Functioning | Baseline, 46 weeks | Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning |
| Depressive Symptoms | Baseline, 46 weeks | Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63) |
| Pain Behavior | Baseline, 46 weeks | Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior |
| Pain Intensity | Baseline, 46 weeks | Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity |
Countries
United States
Participant flow
Pre-assignment details
41 veterans were enrolled, but 2 dropped out before being randomized to treatment condition and did not receive either treatment.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Telephone CBT Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period). | 18 |
| Arm 2 - Telephone Education Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period). | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Total | Arm 1 - Telephone CBT | Arm 2 - Telephone Education |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 10 | 37 years STANDARD_DEVIATION 11 | 34 years STANDARD_DEVIATION 10 |
| Education | 15 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 |
| Marital status Married | 12 participants | 5 participants | 7 participants |
| Marital status Not married | 27 participants | 13 participants | 14 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) White | 23 Participants | 7 Participants | 16 Participants |
| Region of Enrollment United States | 39 participants | 18 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 32 Participants | 16 Participants | 16 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 / 21 |
| serious Total, serious adverse events | 0 / 18 | 0 / 21 |
Outcome results
Primary
Depressive Symptoms
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Time frame: Baseline, 46 weeks
Population: OEF/OIF/OND military veterans with chronic pain
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Telephone CBT | Depressive Symptoms | 46 weeks | 12 units on a scale | Standard Deviation 11 |
| Arm 1 - Telephone CBT | Depressive Symptoms | Baseline | 13 units on a scale | Standard Deviation 8 |
| Arm 2 - Telephone Education | Depressive Symptoms | 46 weeks | 12 units on a scale | Standard Deviation 10 |
| Arm 2 - Telephone Education | Depressive Symptoms | Baseline | 18 units on a scale | Standard Deviation 13 |
p-value: 0.8Mixed Models Analysis
Primary
Level of Functioning
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Time frame: Baseline, 46 weeks
Population: OEF/OIF/OND military veterans with chronic pain
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Telephone CBT | Level of Functioning | 46 weeks | 47 units on a scale | Standard Deviation 11 |
| Arm 1 - Telephone CBT | Level of Functioning | Baseline | 41 units on a scale | Standard Deviation 12 |
| Arm 2 - Telephone Education | Level of Functioning | 46 weeks | 37 units on a scale | Standard Deviation 12 |
| Arm 2 - Telephone Education | Level of Functioning | Baseline | 36 units on a scale | Standard Deviation 9 |
p-value: 0.11Mixed Models Analysis
Primary
Pain Behavior
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
Time frame: Baseline, 46 weeks
Population: OEF/OIF/OND military veterans with chronic pain
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Telephone CBT | Pain Behavior | 46 weeks | 1.0 units on a scale | Standard Deviation 1 |
| Arm 1 - Telephone CBT | Pain Behavior | Baseline | 1.2 units on a scale | Standard Deviation 1 |
| Arm 2 - Telephone Education | Pain Behavior | 46 weeks | 2.1 units on a scale | Standard Deviation 1.4 |
| Arm 2 - Telephone Education | Pain Behavior | Baseline | 2.4 units on a scale | Standard Deviation 1 |
p-value: 0.01Mixed Models Analysis
Primary
Pain Intensity
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Time frame: Baseline, 46 weeks
Population: OEF/OIF/OND military veterans with chronic pain
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 - Telephone CBT | Pain Intensity | 46 weeks | 3.1 units on a scale | Standard Deviation 2.2 |
| Arm 1 - Telephone CBT | Pain Intensity | Baseline | 3.2 units on a scale | Standard Deviation 1.9 |
| Arm 2 - Telephone Education | Pain Intensity | 46 weeks | 4.8 units on a scale | Standard Deviation 2.6 |
| Arm 2 - Telephone Education | Pain Intensity | Baseline | 5.6 units on a scale | Standard Deviation 2.3 |
p-value: 0.09Mixed Models Analysis