Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

Conditions
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Veterans, Persistent Post-surgical Pain

Intervention / Treatment
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* Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-based cognitive behavioral therapy<br>Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management. | Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)<br>* Four session telephone CBT protocol.<br>|
| No Intervention: Treatment as Usual<br>Treatment as Usual (TAU) - Routine perioperative management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 Generalized Anxiety Disorder 7-item (GAD-7) scale measures endorsement/symptoms of generalized anxiety. The scores for each individual question range from 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). A total score can range from 0-21. A score of 5 is a cut-off for mild anxiety, 10 is a cut-off for moderate anxiety, and 15 is a cut-off for severe anxiety. Higher values represent worse outcomes. To compute a total score, all items with endorsements of 1 or greater are added together for a composite score of 0-21. | 3 months post-surgery | 
| Health-related quality of life: SF-36 | SF-36 36-Item Short Form Survey Instrument (SF-36) measures eight constructs related to quality of life: Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health Each item is recoded to reflect score ranges from 0 to 100 where 0 is the least favorable and 100 is the most favorable. Each item corresponds to a specific construct. Items associated with each construct are averaged to retrieve a construct score. Scores are then converted into z-scores. Higher z-scores reflect a more favorable health status. | 3 months post-surgery | 
| Patient satisfaction with outcomes | Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT) Overall, how satisfied are you with the TCBT? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) How satisfied are you with the TCBT for reducing your pain or helping you cope with your pain? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied). | 3 months post-surgery |