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Completed

NCT Number: NCT03351309

Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery

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.

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Key information

Conditions

Persistent Post-surgical Pain Veterans

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iowa City VA Medical Center

Iowa City, Iowa, 52246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >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

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

Treatment and study plan

Telephone-based Cognitive Behavioral Therapy (CBT)

Behavioral

Four session telephone CBT protocol.

Primary outcomes

  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 outcomes

  1. Qualitative analysis of feasibility data

    Time frame: Between 1-2 weeks post-TCBT

    Qualitative interviews with a subset of TCBT participants, until data saturation is reached.

  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. 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.

  8. Patient satisfaction with outcomes

    Time frame: 3 months post-surgery

    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).

Sponsors and collaborators

Lead sponsor

Iowa City Veterans Affairs Medical Center

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2017
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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