Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery
Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress Undergoing Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Investigators are doing this research to understand whether a pre-surgery virtual cognitive behavioral therapy (CBT) group intervention combined with an activity tracker can reduce pain and opioid use in women with chronic stress undergoing elective spine surgery.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Female Gender
- Patients own a compatible smartphone (iPhone or Android) or tablet and can download the Fitbit app on their device
- Planned elective spine surgery
Exclusion Criteria:
- Cognitive impairment (judged to interfere with study participation)
- Male gender
- Non-English speaking
- Pain conditions requiring urgent surgery
- A diagnosis of cancer
- 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
- Visual impairment or motor impairment that would interfere with study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.
|
|
No Intervention: No CBT group
Participants will be asked to wear an activity tracker throughout the duration of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating
Time Frame: At Baseline and weekly until 90 days.
|
Research Subjects will be asked to rate their pain on a scale from 0-10.
|
At Baseline and weekly until 90 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Medication Usage
Time Frame: At Baseline and weekly until 90 days.
|
Research Subjects will be asked to enter their pain medication usage prior to and after surgery.
Medication type (opioid and non-opioid), dose, and quantity will entered into an online App that will be downloaded to the patients phone.
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At Baseline and weekly until 90 days.
|
|
Activity Tracking (Digital Phenotyping)
Time Frame: At Baseline and weekly until 90 days.
|
Investigators will quantify the amount of activity for each study subject (throughout the study up to 90 days) to establish the feasibility of collecting activity data on a wearable activity monitoring device before and after surgery.
In addition, this activity data will be used to establish a digital phenotype by using statistical methods to identify clusters of women with similar recovery trajectories.
Investigators will work to identify two distinct recovery patterns: optimal and slow.
|
At Baseline and weekly until 90 days.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020- P123456
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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