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The purpose of the study is to test a brief, group-administered psychosocial intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.
Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels.
Chronic pain rehabilitation has evolved from a primarily one-dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients.
A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance-based Therapy (AT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, AT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of AT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at VASDHS by the PI, suggests that AT may be superior to CBT as an adjunctive treatment for chronic pain.
The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, manualized group-administered psychosocial intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on AT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 94 veterans with chronic benign pain as a secondary condition. The AT intervention will be compared with treatment as usual (TAU) in a within-subjects design and with CBT in a randomized, between-subjects design. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 6 weeks (after a TAU phase), 12 weeks (after treatment), and at a 6-month follow-up period to investigate maintenance of gains. The study design also allows for an investigation of hypothesized mechanisms of change, acceptance (for AT) and perceived pain control (for CBT). Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Active Comparator | 8 group-administered sessions of Cognitive-Behavioral Therapy |
|
| Acceptance-Based Therapy | Experimental | 8 group-administered sessions of Acceptance-based therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy | Behavioral | 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain. | 12 weeks (post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| West Haven-Yale Multidimensional Pain Inventory - Activity Subscales | This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity. | 12 weeks (post treatment) |
| SF-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie L Wetherell, PhD | VA San Diego Healthcare System, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21683527 | Result | Wetherell JL, Afari N, Rutledge T, Sorrell JT, Stoddard JA, Petkus AJ, Solomon BC, Lehman DH, Liu L, Lang AJ, Atkinson HJ. A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Pain. 2011 Sep;152(9):2098-2107. doi: 10.1016/j.pain.2011.05.016. Epub 2011 Jun 17. | |
| 22200521 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy | 8 group-administered sessions of Cognitive-Behavioral Therapy Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving |
| FG001 | Acceptance-Based Therapy | 8 group-administered sessions of Acceptance-based therapy Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy | 8 group-administered sessions of Cognitive-Behavioral Therapy Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving |
| BG001 | Acceptance-Based Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brief Pain Inventory | This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (post treatment) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | 8 group-administered sessions of Cognitive-Behavioral Therapy Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Wetherell, PI | VA San Diego Healthcare System | 858-552-8585 | 2752 | Julie.Wetherell@va.gov |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Acceptance-based therapy | Behavioral | 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action |
|
|
This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| 12 weeks (post treatment) |
| Beck Depression Inventory | This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms. | 12 weeks (post treatment) |
| Pain Anxiety Symptom Scale - 20 | This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety. | 12 weeks (post treatment) |
| Mostoufi SM, Afari N, Ahumada SM, Reis V, Wetherell JL. Health and distress predictors of heart rate variability in fibromyalgia and other forms of chronic pain. J Psychosom Res. 2012 Jan;72(1):39-44. doi: 10.1016/j.jpsychores.2011.05.007. Epub 2011 Jun 30. |
| Withdrawal by Subject |
|
8 group-administered sessions of Acceptance-based therapy Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Secondary | West Haven-Yale Multidimensional Pain Inventory - Activity Subscales | This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (post treatment) |
|
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| Secondary | SF-12 | This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (post treatment) |
|
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|
|
| Secondary | Beck Depression Inventory | This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (post treatment) |
|
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|
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| Secondary | Pain Anxiety Symptom Scale - 20 | This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks (post treatment) |
|
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|
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| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Arm 2 | 8 group-administered sessions of Acceptance-based therapy Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action | 0 | 49 | 0 | 49 |
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