Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
- Conditions
- Persistent Post-surgical PainVeterans
- Interventions
- Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)
- Registration Number
- NCT03351309
- Lead Sponsor
- Iowa City Veterans Affairs Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- >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
- language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telephone-based cognitive behavioral therapy Telephone-based Cognitive Behavioral Therapy (CBT) Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management.
- Primary Outcome Measures
Name Time Method Pain Severity 3 months post-surgery Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
- Secondary Outcome Measures
Name Time Method Qualitative analysis of feasibility data Between 1-2 weeks post-TCBT Qualitative interviews with a subset of TCBT participants, until data saturation is reached.
Pain severity - continuous 3 months post-surgery Brief Pain Inventory
Pain-related functioning 3 months post-surgery Pain Disability Index
Opioid and other analgesic use 3 months post-surgery Self-report medication use
Depression 3 months post-surgery Patient Health Questionnaire
Anxiety 3 months post-surgery 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.Health-related quality of life: SF-36 3 months post-surgery 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.Patient satisfaction with outcomes 3 months post-surgery 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).
Trial Locations
- Locations (1)
Iowa City VA Medical Center
🇺🇸Iowa City, Iowa, United States