Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery
NCT ID: NCT06335485
Last Updated: 2024-03-28
Study Results
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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COMPLETED
NA
32 participants
INTERVENTIONAL
2021-04-01
2022-09-29
Brief Summary
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Detailed Description
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Participants will be randomly divided in two groups and one of the groups will be invited to attend four weekly virtual CBT group sessions designed to improve reactions to stress, increase motivation for physical activity, develop tools for managing pain, and utilize mindfulness techniques. Two optional sessions will be available following surgery. Individuals randomized to usual care will not attend the online sessions but will continue to wear the activity tracker to provide information about their physical activity as well as the use of an App to track their pain and medication use.
The ultimate goal of this research is to enhance stress management and coping skills to help patients better manage pain after surgery and reduce their need for opioid medications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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CBT intervention group
Participants will be asked to wear an activity tracker throughout the duration of the study. In addition, Participants will attend 4 weekly online virtual CBT sessions that will provide information on stress and pain reduction techniques before surgery, and 2 sessions following surgery.
Cognitive Behavioral Therapy
Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.
No CBT group
Participants will be asked to wear an activity tracker throughout the duration of the study.
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy
Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.
Eligibility Criteria
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Inclusion Criteria
2. Female Gender
3. Patients own a compatible smartphone (iPhone or Android) or tablet and can download the Fitbit app on their device
4. Planned elective spine surgery
Exclusion Criteria
2. Male gender
3. Non-English speaking
4. Pain conditions requiring urgent surgery
5. A diagnosis of cancer
6. A present psychiatric condition (e.g. DSM diagnosis of schizophrenia, delusional disorder, psychotic disorder or dissociative disorder) that would be judged to interfere with the study
7. Visual impairment or motor impairment that would interfere with study participation
18 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Linda S Aglio
Anesthesiologist, Associate Professor
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2020- P123456
Identifier Type: -
Identifier Source: org_study_id
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