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Acceptance and Commitment Therapy for Chronic Post-Surgical Pain
N/A
Recruiting
Led By Christine B. Sieberg
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Inability to speak sufficient English or another language that can be interpreted orally and for questionnaires with the research team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will help researchers understand more about chronic post-surgical pain, provide a way to measure it, and understand how age affects it.
Who is the study for?
This trial is for males and females aged 12 or older who have had surgery at least 6 months ago and are experiencing chronic pain that has lasted for more than 3 months post-surgery. Participants must be able to communicate in English or a language the research team can interpret. Those with severe cognitive impairments, significant psychiatric disorders, or illegal hard drug use are excluded.
What is being tested?
The study aims to understand the psychophysical and neural mechanisms of chronic post-surgical pain (CPSP) across different ages. It will evaluate how Acceptance and Commitment Therapy may influence CPSP by examining neurobiological factors, providing metrics for patient follow-up, predicting chronification risks, and exploring age-related differences.
What are the potential side effects?
Since this trial involves Acceptance and Commitment Therapy—a psychological intervention rather than medication—traditional side effects like those seen with drugs are not expected. However, participants might experience emotional discomfort when discussing painful experiences.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot communicate effectively in English or any language the research team understands.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain acceptance using the Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R)
Secondary study objectives
Functional brain metrics using fNIRS
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: ACT Group InterventionActive Control1 Intervention
We will evaluate the effects of an Acceptance and Commitment Therapy (ACT) one-day group intervention (with 1-month post group zoom booster session) on the functional near-infrared spectroscopy (fNIRS) signal in groups of adolescents and adult patients diagnosed with CPSP at \>3 months post major orthopedic surgery.
Group II: Treatment as UsualActive Control1 Intervention
Treatment as Usual (TAU) for those with CPSP
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,679 Total Patients Enrolled
Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,796 Total Patients Enrolled
Christine B. SiebergPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not use illegal drugs, or if I do, they are prescribed.I cannot communicate effectively in English or any language the research team understands.You have a history of severe cognitive problems, such as intellectual disability or serious head injury.You have serious mental health conditions.I am 12 or older, had surgery over 6 months ago, and have had pain for 3 months or more after it.
Research Study Groups:
This trial has the following groups:- Group 1: ACT Group Intervention
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.