Stress Disorders, Post-Traumatic
Conditions
Keywords
Psychology, Pain, Veterans, Stress Disorders, Post-Traumatic
Brief summary
This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.
Detailed description
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.
Interventions
BEHAVIORALIntensive 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.
BEHAVIORALTreatment as Usual
Treatment as Usual.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology. * Patients must also meet diagnostic criteria for PTSD.
Exclusion criteria
* Patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 11 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | fail to engage >3 sessions | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Treatment as Usual | Intensive Treatment | Total |
|---|---|---|---|
| Age, Continuous | 52.09 years STANDARD_DEVIATION 10.64 | 47.75 years STANDARD_DEVIATION 10.39 | 49.79 years STANDARD_DEVIATION 10.274 |
| Race/Ethnicity, Customized African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment United States | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Treatment | McGill Pain Questionnaire | 31.91 units on a scale | Standard Deviation 13.55 |
| Treatment as Usual | McGill Pain Questionnaire | 30.83 units on a scale | Standard Deviation 13.61 |