Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No CBT group | No Intervention | Participants will be asked to wear an activity tracker throughout the duration of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Activity Tracking (Digital Phenotyping) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Females only
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
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. |