Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery

March 21, 2024 updated by: Linda S Aglio, Brigham and Women's Hospital

Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress Undergoing Surgery

This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older
  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:

  1. Cognitive impairment (judged to interfere with study participation)
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: Cognitive Behavioral Therapy
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

September 29, 2022

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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