Clinical Trials Directory

Trials / Completed

CompletedNCT06335485

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral TherapyParticipants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.

Timeline

Start date
2021-04-01
Primary completion
2022-09-29
Completion
2022-09-29
First posted
2024-03-28
Last updated
2024-03-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06335485. Inclusion in this directory is not an endorsement.