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Trial record 44 of 1598 for:    veterans affairs medical center

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 : March 1, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Katherine Hadlandsmyth, Iowa City Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE November 2, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE November 25, 2017
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
Pain Severity [ Time Frame: 3 months post-surgery ]
Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03351309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • 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.
  • Pain severity - continuous [ Time Frame: 3 months post-surgery ]
    Brief Pain Inventory
  • Pain-related functioning [ Time Frame: 3 months post-surgery ]
    Pain Disability Index
  • Opioid and other analgesic use [ Time Frame: 3 months post-surgery ]
    Self-report medication use
  • Depression [ Time Frame: 3 months post-surgery ]
    Patient Health Questionnaire
  • 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.
  • Health-related quality of life: SF-36 [ 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.
  • 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? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
    2. 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)
    3. How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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.
  • Pain severity - continuous [ Time Frame: 3 months post-surgery ]
    Brief Pain Inventory
  • Pain-related functioning [ Time Frame: 3 months post-surgery ]
    Pain Disability Index
  • Opioid and other analgesic use [ Time Frame: 3 months post-surgery ]
    Self-report medication use
  • Depression [ Time Frame: 3 months post-surgery ]
    Patient Health Questionnaire
  • 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.
  • 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.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
Official Title  ICMJE Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Persistent Post-surgical Pain
  • Veterans
Intervention  ICMJE Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)
Four session telephone CBT protocol.
Study Arms  ICMJE
  • Experimental: Telephone-based cognitive behavioral therapy
    Telephone-based cognitive behavioral therapy (CBT) intervention - Four session protocol plus routine perioperative management.
    Intervention: Behavioral: Telephone-based Cognitive Behavioral Therapy (CBT)
  • No Intervention: Treatment as Usual
    Treatment as Usual (TAU) - Routine perioperative management.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine Hadlandsmyth, Ph.D. 800-777-8442 ext 7-5688 katherine-hadlandsmyth@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03351309
Other Study ID Numbers  ICMJE 201708823
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katherine Hadlandsmyth, Iowa City Veterans Affairs Medical Center
Study Sponsor  ICMJE Iowa City Veterans Affairs Medical Center
Collaborators  ICMJE US Department of Veterans Affairs
Investigators  ICMJE
Principal Investigator: Katherine Hadlandsmyth, Ph.D. University of Iowa
PRS Account Iowa City Veterans Affairs Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP