Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

Veterans Clinical Trial

Official title:

Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351309
• Other study ID #: 201708823
• Status: Completed
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Iowa City Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Persistent Post-surgical Pain
• Veterans

Intervention

Behavioral:
• Telephone-based Cognitive Behavioral Therapy (CBT)
Four session telephone CBT protocol.

Locations

Country	Name	City	State
United States	Iowa City VA Medical Center	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa City Veterans Affairs Medical Center	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)	3 months post-surgery
Secondary	Qualitative analysis of feasibility data	Qualitative interviews with a subset of TCBT participants, until data saturation is reached.	Between 1-2 weeks post-TCBT
Secondary	Pain severity - continuous	Brief Pain Inventory	3 months post-surgery
Secondary	Pain-related functioning	Pain Disability Index	3 months post-surgery
Secondary	Opioid and other analgesic use	Self-report medication use	3 months post-surgery
Secondary	Depression	Patient Health Questionnaire	3 months post-surgery
Secondary	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
Secondary	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
Secondary	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