Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

• Sponsor: Iowa City Veterans Affairs Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03351309
• Collaborator: US Department of Veterans Affairs (U.S. Fed)
• Enrollment: 110
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.2
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Post-surgical Pain; Veterans	Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
• Actual Study Start Date: Nov 25, 2017
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Qualitative analysis of feasibility data [Between 1-2 weeks post-TCBT]

   Qualitative interviews with a subset of TCBT participants, until data saturation is reached.

2. Pain severity - continuous [3 months post-surgery]

   Brief Pain Inventory

3. Pain-related functioning [3 months post-surgery]

   Pain Disability Index

4. Opioid and other analgesic use [3 months post-surgery]

   Self-report medication use

5. Depression [3 months post-surgery]

   Patient Health Questionnaire

6. 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.

7. 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.

8. Patient satisfaction with outcomes [3 months post-surgery]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iowa City VA Medical Center	Iowa City	Iowa	United States	52246

Sponsors and Collaborators

• Iowa City Veterans Affairs Medical Center
• US Department of Veterans Affairs

Investigators

• Principal Investigator: Katherine Hadlandsmyth, Ph.D., University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katherine Hadlandsmyth, Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine, Iowa City Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT03351309
• Other Study ID Numbers: 201708823
• First Posted: Nov 22, 2017
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Aug 24, 2021