Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults
NCT ID: NCT05304286
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2022-04-07
2026-06-30
Brief Summary
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Detailed Description
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Dr. Sieberg will conduct the groups with assistance from the RA. Dr. Sieberg is a licensed clinical psychologist, who has delivered manualized ACT for chronic pain in her clinical practice. The intervention follows a manual patterned after an existing 1-day ACT intervention for chronic pain and will be adapted to meet the needs of patients with ongoing CPSP. Topics covered in the workshop include: (1) mindfulness of troublesome thoughts, feelings, and physical sensations; (2) willingness to face and accept experiences that cannot be changed; (3) identifying values; and (4) promoting behavior changes that support value-based action.
The goal of the ACT intervention is to increase awareness of thoughts, feelings, and behaviors that exacerbate pain while minimizing avoidance that interferes with engagement in valued action. Participants will also receive an individually tailored 30-minute booster session via zoom one month following the workshop. During the booster session, ACT principles will be reinforced and the participant will work together with Dr. Sieberg to problem-solve and address any difficulties engaging in ACT exercises and practices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACT Group 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.
Acceptance and Commitment Therapy
The aim of ACT is to address avoidance behaviors by increasing openness to difficult experiences, such as pain, and to develop an awareness of behavioral options that will aid to facilitate behavior change processes that are in accord with living a values-based life.
Treatment as Usual
Treatment as Usual (TAU) for those with CPSP
No interventions assigned to this group
Interventions
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Acceptance and Commitment Therapy
The aim of ACT is to address avoidance behaviors by increasing openness to difficult experiences, such as pain, and to develop an awareness of behavioral options that will aid to facilitate behavior change processes that are in accord with living a values-based life.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe cognitive impairment by history (e.g., intellectual disability, severe head injury)
* Patients with significant psychiatric disorders
* Use of illegal hard drugs including MDMA, heroin, methamphetimes, amphetamines, cocaine, ketamine, benzodiazepines, and phencyclidine. Absence of such drugs will be confirmed in a urine drug screen during the visit. If prescription medication includes any of these compounds, that medication is not exclusionary.
12 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Christine B. Sieberg, PhD
Associate Professor of Psychology, Department of Psychiatry, Harvard Medical School
Principal Investigators
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Christine B. Sieberg
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-P000634
Identifier Type: -
Identifier Source: org_study_id
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