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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06335485
• Other study ID #: 2020- P123456
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Cognitive Behavioral Therapy
• Surgery

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating	Research Subjects will be asked to rate their pain on a scale from 0-10.	At Baseline and weekly until 90 days.
Secondary	Pain Medication Usage	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.
Secondary	Activity Tracking (Digital Phenotyping)	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.