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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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The study team propose to investigate the feasibility and pilot a Telephone Cognitive Behavioral Therapy intervention for those identified to be at risk for chronic pain following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone-based cognitive behavioral therapy | Experimental | Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management. |
|
| Treatment as Usual | No Intervention | Treatment as Usual (TAU) - Routine perioperative management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-based Cognitive Behavioral Therapy (CBT) | Behavioral | Four session telephone CBT protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+) | 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative analysis of feasibility data | Qualitative interviews with a subset of TCBT participants, until data saturation is reached. | Between 1-2 weeks post-TCBT |
| Pain severity - continuous | Brief Pain Inventory |
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Inclusion Criteria:
1) >18 years of age, 2) scheduled for hernia repair, breast surgery, amputation, thoracotomy, cholecystectomy, cardiac surgery, splenectomy, orthopedic, urological or vascular surgery, 3) Rural dwelling
Exclusion Criteria:
1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Hadlandsmyth, Ph.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Medical Center | Iowa City | Iowa | 52246 | United States |
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| 3 months post-surgery |
| Pain-related functioning | Pain Disability Index | 3 months post-surgery |
| Opioid and other analgesic use | Self-report medication use | 3 months post-surgery |
| Depression | Patient Health Questionnaire | 3 months post-surgery |
| Anxiety | Generalized Anxiety Disorder Scale
| 3 months post-surgery |
| Health-related quality of life: SF-36 | SF-36
| 3 months post-surgery |
| Patient satisfaction with outcomes | Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT)
| 3 months post-surgery |