Clinical trial NCT06335485: Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery
Official title: Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Cognitive Behavioral Therapy
Surgery
Keywords: Chronic stress
Elective spine surgery
Cognitive Behavioral Therapy
Digital Phenotyping
Fitbit tracker
Back Pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating
timeFrame: At Baseline and weekly until 90 days.
Secondary outcomes:
measure: Pain Medication Usage
timeFrame: At Baseline and weekly until 90 days.
measure: Activity Tracking (Digital Phenotyping)
timeFrame: At Baseline and weekly until 90 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: