NCT03351309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

November 25, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

3.7 years

First QC Date

November 2, 2017

Last Update Submit

August 23, 2021

Conditions

Persistent Post-surgical PainVeterans

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

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

    3 months post-surgery

Secondary Outcomes (8)

  • Qualitative analysis of feasibility data

    Between 1-2 weeks post-TCBT

  • Pain severity - continuous

    3 months post-surgery

  • Pain-related functioning

    3 months post-surgery

  • Opioid and other analgesic use

    3 months post-surgery

  • Depression

    3 months post-surgery

  • +3 more secondary outcomes

Study Arms (2)

Telephone-based cognitive behavioral therapy

EXPERIMENTAL

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

Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)

Treatment as Usual

NO INTERVENTION

Treatment as Usual (TAU) - Routine perioperative management.

Interventions

Telephone-based Cognitive Behavioral Therapy (CBT)BEHAVIORAL

Four session telephone CBT protocol.

Telephone-based cognitive behavioral therapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) \>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

You may not qualify if:

  • \) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa City VA Medical Center

Iowa City, Iowa, 52246, United States

Location

Study Officials

  • Katherine Hadlandsmyth, Ph.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 22, 2017

Study Start

November 25, 2017

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

US(1)