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Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

Primary Purpose

Persistent Post-surgical Pain, Veterans

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-based Cognitive Behavioral Therapy (CBT)
Sponsored by
Iowa City Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Persistent Post-surgical Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Iowa City VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone-based cognitive behavioral therapy

Treatment as Usual

Arm Description

Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management.

Treatment as Usual (TAU) - Routine perioperative management.

Outcomes

Primary Outcome Measures

Pain Severity
Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)

Secondary Outcome Measures

Qualitative analysis of feasibility data
Qualitative interviews with a subset of TCBT participants, until data saturation is reached.
Pain severity - continuous
Brief Pain Inventory
Pain-related functioning
Pain Disability Index
Opioid and other analgesic use
Self-report medication use
Depression
Patient Health Questionnaire
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.
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.
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).

Full Information

First Posted
November 2, 2017
Last Updated
August 23, 2021
Sponsor
Iowa City Veterans Affairs Medical Center
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT03351309
Brief Title
Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
Official Title
Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2017 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa City Veterans Affairs Medical Center
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Post-surgical Pain, Veterans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone-based cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as Usual (TAU) - Routine perioperative management.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based Cognitive Behavioral Therapy (CBT)
Intervention Description
Four session telephone CBT protocol.
Primary Outcome Measure Information:
Title
Pain Severity
Description
Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
Time Frame
3 months post-surgery
Secondary Outcome Measure Information:
Title
Qualitative analysis of feasibility data
Description
Qualitative interviews with a subset of TCBT participants, until data saturation is reached.
Time Frame
Between 1-2 weeks post-TCBT
Title
Pain severity - continuous
Description
Brief Pain Inventory
Time Frame
3 months post-surgery
Title
Pain-related functioning
Description
Pain Disability Index
Time Frame
3 months post-surgery
Title
Opioid and other analgesic use
Description
Self-report medication use
Time Frame
3 months post-surgery
Title
Depression
Description
Patient Health Questionnaire
Time Frame
3 months post-surgery
Title
Anxiety
Description
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
Title
Health-related quality of life: SF-36
Description
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
Title
Patient satisfaction with outcomes
Description
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).
Time Frame
3 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Hadlandsmyth, Ph.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Medical Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States

12. IPD Sharing Statement

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Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

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