Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

NCT ID: NCT03351309

Last Updated: 2021-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-25

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Post-surgical Pain Veterans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Telephone-based cognitive behavioral therapy

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

Group Type EXPERIMENTAL

Telephone-based Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

Four session telephone CBT protocol.

Treatment as Usual

Treatment as Usual (TAU) - Routine perioperative management.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telephone-based Cognitive Behavioral Therapy (CBT)

Four session telephone CBT protocol.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

Iowa City Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Katherine Hadlandsmyth

Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Hadlandsmyth, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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Iowa City VA Medical Center

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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201708823

Identifier Type: -

Identifier Source: org_study_id

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