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This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.
Objectives:
The primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). A secondary objective is to examine potential mechanisms of action that might account for improvements in pain or PTSD. Third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. It is hypothesized that 1) participants receiving the intensive treatment (PT) will report significantly greater decreases in symptoms of pain and PTSD from pre-treatment to post-treatment when compared to participants randomized to a standard care (SC) condition, and 2) participants receiving PT will show greater maintenance of change on measures of pain and PTSD at 3 months following the completion of treatment when compared to participants randomized to the SC condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Treatment | Experimental | Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain |
|
| Treatment as Usual | Experimental | Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Treatment | Behavioral | Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration. |
| Measure | Description | Time Frame |
|---|---|---|
| McGill Pain Questionnaire | McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Otis, BS BA PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22781019 | Result | Tsai J, Whealin JM, Scott JC, Harpaz-Rotem I, Pietrzak RH. Examining the relation between combat-related concussion, a novel 5-factor model of posttraumatic stress symptoms, and health-related quality of life in Iraq and Afghanistan veterans. J Clin Psychiatry. 2012 Aug;73(8):1110-8. doi: 10.4088/JCP.11m07587. Epub 2012 Jun 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Treatment | Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration. |
| FG001 | Treatment as Usual | Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Treatment | Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration. |
| 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 | McGill Pain Questionnaire | McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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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 | Intensive Treatment | Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration. |
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Small N due to challenges associated with recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Otis | VA Boston Healthcare System | 857-364-5740 | john.otis@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Behavioral | Treatment as Usual. |
|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| BG001 |
| Treatment as Usual |
Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Treatment as Usual | Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Treatment as Usual | Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual. | 0 | 11 | 0 | 11 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |