Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

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 Overview

• Status: Completed
• Conditions: Veterans; Persistent Post-surgical Pain
• Intervention / Treatment: Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • Iowa City VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 functioningRole limitations due to physical healthRole limitations due to emotional problemsEnergy/fatigueEmotional well-beingSocial functioningPainGeneral 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

Collaborators and Investigators

• Sponsor: Iowa City Veterans Affairs Medical Center
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: Katherine Hadlandsmyth, Ph.D., University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2017
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 201708823

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No