ClinicalTrials.gov
ClinicalTrials.gov Menu

Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03351309
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
U.S. Department of Veterans Affairs Office of Rural Health
Information provided by (Responsible Party):
Katherine Hadlandsmyth, Iowa City Veterans Affairs Medical Center

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) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : November 25, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 31, 2019

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.



Primary Outcome Measures :
  1. Pain Severity [ Time Frame: 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 [ Time Frame: Between 1-2 weeks post-TCBT ]
    Qualitative interviews with a subset of TCBT participants A subset of TCBT participants will be invited to participate in qualitative interviews about their perception of the TCBT intervention. Following the first 5 participants randomized to TCBT, each Veteran randomized to the TCBT intervention will be given the opportunity to participate in a qualitative interview (until 8 interviews are completed). Qualitative interviews will be conducted over the telephone and audio-recorded for transcription. Each interview will take approximately 15 - 25 minutes.

  2. Pain severity - continuous [ Time Frame: 3 months post-surgery ]
    Brief Pain Inventory

  3. Pain-related functioning [ Time Frame: 3 months post-surgery ]
    Pain Disability Index

  4. Opioid and other analgesic use [ Time Frame: 3 months post-surgery ]
    Self-report medication use

  5. Depression [ Time Frame: 3 months post-surgery ]
    Patient Health Questionnaire

  6. Anxiety [ Time Frame: 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. Quality of Life [ Time Frame: 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 [ Time Frame: 3 months post-surgery ]

    Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT)

    1. Overall, how satisfied are you with the TCBT?
    2. How satisfied are you with the TCBT for reducing your pain or helping you cope with your pain?
    3. How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications. Exclusion criteria will be confirmed per coordinator through direct screening.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351309


Contacts
Contact: Katherine Hadlandsmyth, Ph.D. 800-777-8442 ext 7-5688 katherine-hadlandsmyth@uiowa.edu

Locations
United States, Iowa
Iowa City VA Medical Center Recruiting
Iowa City, Iowa, United States, 52246
Contact: Katherine E Hadlandsmyth    319-467-5688    katherine-hadlandsmyth@uiowa.edu   
Sponsors and Collaborators
Iowa City Veterans Affairs Medical Center
U.S. Department of Veterans Affairs Office of Rural Health
Investigators
Principal Investigator: Katherine Hadlandsmyth, Ph.D. University of Iowa

Responsible Party: Katherine Hadlandsmyth, Clinical Assistant Professor of Anesthesia - Chronic Pain Medicine, Iowa City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03351309     History of Changes
Other Study ID Numbers: 201708823
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No