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Completed

NCT Number: NCT06335485

Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women 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.

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Key information

Conditions

Back Pain Cognitive Behavioral Therapy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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