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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
110
Four session telephone CBT protocol.
Iowa City VA Medical Center
Iowa City, Iowa, United States
Pain Severity
Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
Time frame: 3 months post-surgery
Qualitative analysis of feasibility data
Qualitative interviews with a subset of TCBT participants, until data saturation is reached.
Time frame: Between 1-2 weeks post-TCBT
Pain severity - continuous
Brief Pain Inventory
Time frame: 3 months post-surgery
Pain-related functioning
Pain Disability Index
Time frame: 3 months post-surgery
Opioid and other analgesic use
Self-report medication use
Time frame: 3 months post-surgery
Depression
Patient Health Questionnaire
Time frame: 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.
Time frame: 3 months post-surgery
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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.
Time frame: 3 months post-surgery
Patient satisfaction with outcomes
Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT) 1. Overall, how satisfied are you with the TCBT? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 2. 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) 3. How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).
Time frame: 3 months post-surgery