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

Mass General Brigham

Status: Completed

Conditions: Back Pain; Surgery; Cognitive Behavioral Therapy

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06335485

2020- P123456

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

CBT intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

No CBT group

No Intervention group

Description:

Participants will be asked to wear an activity tracker throughout the duration of the study.