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The purpose of this study is to examine the efficacy of an integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that Veterans who receive the integrated treatment will report more positive outcomes than individuals who are assigned to treatment as usual, pain treatment, or PTSD treatment.
Chronic pain and post-traumatic stress disorder frequently co-occur and are associated with a significant level of affective distress, physical disability, and treatment resistance. However, no empirical studies have been conducted investigating the efficacy of a treatment tailored specifically for individuals with comorbid chronic pain and PTSD.
The primary objective of this study is to evaluate the efficacy of a cognitive-behavioral therapy approach for comorbid chronic pain and PTSD. A secondary objective of this study is to examine potential mechanisms of action that might mediate treatment outcome. It is hypothesized that:
1.a) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report significantly greater improvements on measures of pain, affective distress, and physical functioning from pre-treatment to post-treatment than participants in the Cognitive Behavioral Treatment for chronic pain, Cognitive Processing Therapy (CPT) for PTSD, or Treatment as Usual (TAU) conditions
1.b) All active treatments will be more effective at promoting improved outcomes than Treatment as Usual
2) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report decreased symptoms of PTSD from pre-treatment to post-treatment when compared to participants in the other conditions.
3) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report greater maintenance of change, and greater improvements on measures of Pain, Affective Distress, Physical Functioning, and PTSD at 6 months following the completion of treatment than participants in the other three conditions
4) As a secondary/exploratory hypothesis, the researchers will examine potential mechanisms of action in treatment.
It is hypothesized that changes in these potential mechanisms will mediate treatment outcome. The proposed study is a four-treatment condition by three-evaluation period (pre-treatment, post-treatment, and 6-month follow-up) repeated measures factorial design with multiple dependent measures. Participants will be 136 patients with co-morbid chronic pain and PTSD receiving care in the VA Boston Healthcare System. Participants in the active treatment conditions will complete 11 weekly outpatient therapy sessions. A clinical psychologist with specialized training in providing both PTSD and chronic pain treatment protocols will conduct therapy in an individual format, 90 minutes in duration. Participants assigned to the TAU condition will not receive treatment beyond that provided by their primary care provider and other healthcare providers. The Cognitive Behavioral Therapy-PAIN condition will follow an adaptation of a manualized treatment protocol used by Kerns and colleagues that emphasizes identifying and modifying maladaptive thoughts and behaviors related to the experience of chronic pain. Participants in the Cognitive Processing Therapy - PTSD condition will receive a manualized treatment protocol that includes several empirically supported techniques including cognitive restructuring, exposure therapy, and skills training. Participants in the Cognitive Behavioral Therapy - Integrated condition will receive an integrated treatment for comorbid pain and PTSD including components of the pain and PTSD treatments described above.
The proposed study will address the specific objectives of the National Pain Management Strategy by helping to assure that clinicians practicing in the VA healthcare system are adequately prepared to assess and manage chronic pain effectively, especially when comorbid with PTSD. Knowledge gained from the proposed study could potentially be utilized by psychologists and other healthcare providers across the VA system nationwide who are currently engaged in Cognitive Behavioral Therapy treatment programs for chronic pain and PTSD. Given that Cognitive Behavioral Therapy has been shown to be efficacious for pain and PTSD, but not for comorbid pain and PTSD, it is imperative that a new integrated treatment be evaluated that has the potential to address the unmet needs of this large population. Thus, this study will have important implications for the delivery of pain management services to veterans and others with chronic pain and PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy - Pain | Experimental | Cognitive Behavioral Therapy targeting chronic pain |
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| Cognitive Behavioral Therapy-Integrated | Experimental | Integrated treatment for comorbid chronic pain and PTSD |
|
| Cognitive Processing Therapy - PTSD | Experimental | Cognitive Processing Therapy for PTSD |
|
| Treat as Usual | Other | Participants received care for pain and PTSD as usual from their Primary care provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy - Pain | Behavioral | Pain treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered Assessment of PTSD | This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD. | Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Otis, BS BA PhD | VA Boston Health Care System, Jamaica Plain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Health Care System, Jamaica Plain | Boston | Massachusetts | 02130 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study: Integrated Treatment for Chronic Pain and PTSD | View source |
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If it was determined during the assessment that a participant did not meet criteria for PTSD or would be excluded based on pre-determined exclusion criteria (e.g., substance use, no pain, psychosis) then the assessment was terminated and additional study related data was not collected. This was done to reduce unnecessary participant burden.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy - Pain | Cognitive Behavioral Therapy targeting chronic pain |
| FG001 | Cognitive Processing Therapy - PTSD | Cognitive processing therapy for PTSD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cognitive Behavioral Therapy-Integrated |
| Behavioral |
Integrated treatment |
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| Cognitive Processing Therapy - PTSD | Behavioral | Cognitive processing therapy |
|
| Treat as Usual | Behavioral | Treatment as usual |
|
| FG002 | Cognitive Behavioral Therapy - Integrated | Integrated treatment for comorbid chronic pain and PTSD |
| FG003 | Treat as Usual | Participants received care for pain and PTSD as usual from their primary care provider. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy - Pain | Cognitive Behavioral Therapy targeting chronic pain |
| BG001 | Cognitive Processing Therapy-PTSD | Cognitive processing therapy for PTSD |
| BG002 | Cognitive Behavioral Therapy-Integrated | Integrated treatment for comorbid chronic pain and PTSD |
| BG003 | Treat as Usual | Participants received care for pain and PTSD as usual from their primary care provider. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Clinician Administered Assessment of PTSD | This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD. | Posted | Mean | Standard Deviation | units on a scale | Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up |
|
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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 | Cognitive Behavioral Therapy - Pain | Cognitive Behavioral Therapy targeting chronic pain | 0 | 12 | 0 | 12 | ||
| EG001 | Cognitive Processing Therapy - PTSD | Cognitive processing therapy for PTSD | 0 | 10 | 0 | 10 | ||
| EG002 | Cognitive Behavioral Therapy-Integrated | Integrated treatment for comorbid chronic pain and PTSD | 0 | 13 | 0 | 13 | ||
| EG003 | Treat as Usual | Participants received care for pain and PTSD as usual from their primary care provider. | 0 | 7 | 0 | 7 |
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Failure to engage in treatment, failure to complete treatment in a timely manner due to missed treatment sessions, and difficulty with compliance with treatment session recommendations led to lower completion rates
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Otis | VA Boston Healthcare System | 8573645740 | john.otis@va.gov |
| ID | Term |
|---|---|
| D010146 | Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003033 | Coal Tar |
| ID | Term |
|---|---|
| D013638 | Tars |
| D045424 | Complex Mixtures |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Posttreatment |
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| 6 month Follow-up |
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