Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT03351309|
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : March 1, 2019
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Telephone Cognitive Behavioral Therapy for Veterans Undergoing Surgery|
|Actual Study Start Date :||November 25, 2017|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
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.
- Pain Severity [ Time Frame: 3 months post-surgery ]Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+)
- 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 ]
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
- Emotional well-being
- Social functioning
- 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)
- 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).
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
|Contact: Katherine Hadlandsmyth, Ph.D.||800-777-8442 ext firstname.lastname@example.org|
|United States, Iowa|
|Iowa City VA Medical Center||Recruiting|
|Iowa City, Iowa, United States, 52246|
|Contact: Katherine E Hadlandsmyth 319-467-5688 email@example.com|
|Principal Investigator:||Katherine Hadlandsmyth, Ph.D.||University of Iowa|