Back PainNCT06335485
Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery
A study testing Cognitive Behavioral Therapy in people with Back Pain and Cognitive Behavioral Therapy, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Back Pain, Cognitive Behavioral Therapy, Surgery
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 29 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress 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.
Read the 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.
- Conditions
- Back Pain, Cognitive Behavioral Therapy, Surgery
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Chronic stress, Elective spine surgery, Cognitive Behavioral Therapy, Digital Phenotyping, Fitbit tracker, Back Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Participants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| No CBT group | No intervention | Participants will be asked to wear an activity tracker throughout the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating
Research Subjects will be asked to rate their pain on a scale from 0-10.
Measured: At Baseline and weekly until 90 days.
Secondary outcomes (2)
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.
Measured: At Baseline and weekly until 90 days.
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.
Measured: At Baseline and weekly until 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2021
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda S Aglio, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335485
- Sponsor's protocol ID
- 2020- P123456
- Status last verified
- Mar 2024
- First submitted
- 23 Jun 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Phenotyping to Monitor a CBT Pain Prevention Intervention for Women With Chronic Life Stress Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06335485
- Acronym / sponsor ID
- 2020- P123456
- Conditions
- Back Pain, Cognitive Behavioral Therapy, Surgery
- Keywords
- Chronic stress, Elective spine surgery, Cognitive Behavioral Therapy, Digital Phenotyping, Fitbit tracker, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBT intervention group | Experimental | Behavioral: Cognitive Behavioral TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Cognitive impairment (judged to interfere with study participation)
- Male gender
- Non-English speaking
- Pain conditions requiring urgent surgery
- A diagnosis of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyParticipants will attend 4 CBT sessions prior to surgery and 2 optional sessions after surgery. | Behavioural | CBT intervention group |
Primary outcome
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.
2 secondary outcomes
Pain Medication Usage
Time frame: At Baseline and weekly until 90 days.
Activity Tracking (Digital Phenotyping)
Time frame: At Baseline and weekly until 90 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Back Pain and Cognitive Behavioral Therapy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating (time frame: At Baseline and weekly until 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.