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

NCT06335485 | Completed

• 1 other identifier: 2020- P123456
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain; Cognitive Behavioral Therapy; Surgery

Keywords

Chronic stress; Elective spine surgery; Cognitive Behavioral Therapy; Digital Phenotyping; Fitbit tracker; Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Medication Usage

  At Baseline and weekly until 90 days.

• Activity Tracking (Digital Phenotyping)

  At Baseline and weekly until 90 days.

Study Arms (2)

CBT intervention group

EXPERIMENTAL

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

No CBT group

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.

CBT intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate Professor

Model Details: Patients are randomized to either the intervention group or general group, for the intervention group patients will be randomly assigned to attend 4 weekly online virtual CBT sessions that will provide information on stress and pain reduction techniques before surgery, and 2 sessions following patient surgery.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: March 28, 2024
• Study Start: April 1, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

US (1)