Chronic Pain Skills Study - Vanderbilt University Medical Center

NCT03384953 | Completed Results

• 1 other identifier: 170652
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The Osher Center for Integrative Medicine (OCIM) at Vanderbilt is a multidisciplinary outpatient clinic treating patients with chronic pain and complex health issues via integrative services, with goals of improving overall health and wellbeing of those served. At OCIM, clinical hypnosis has been historically provided on an individual basis by the investigator. Due to its impact and increased patient demand for this service, the investigator will be conducting group hypnosis services in addition to individual services order to expand the reach of this program to participants. As such, the investigators see this as a tremendous opportunity to contribute to clinical research to contribute to the evidence based for this form of service by examining participant-reported outcomes associated with completing the treatment. For this project, the investigators seek to assess the impact of a manualized group treatment protocol utilizing clinical hypnosis as a treatment for chronic pain. The investigators will be evaluating participant-reported outcomes to assess the feasibility of conducting hypnosis in this setting, impact of group hypnosis on pain and how participants' responsiveness to hypnosis impacts treatment outcome.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Brief Pain Inventory (severity scale only) is a 4-item subscale of the Brief Pain Inventory assessing the severity of pain over the past week. Questions inquire into an individual's worst, least, average, and current levels of pain on an 11-point likert scale, with 0 being no pain. It has been validated and is considered the gold standard to utilize in patient-reported outcomes studies. It takes \<1 minute to complete.

  baseline and 6 months

Study Arms (2)

Clinical Hypnosis - Group Treatment

EXPERIMENTAL

Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in a group setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.

Behavioral: Clinical Hypnosis - Group Treatment

Clinical Hypnosis - Individual Treatment

EXPERIMENTAL

Subjects will receive 8 weeks of a manualized clinical hypnosis for chronic pain treatment in an individual, 1:1 setting. Assessments will be completed before, immediately after, and at 3- and 6- months post-treatment to assess for treatment gains.

Behavioral: Clinical Hypnosis - Individual Treatment

Interventions

Clinical Hypnosis - Group Treatment BEHAVIORAL

group treatment

Clinical Hypnosis - Group Treatment

Clinical Hypnosis - Individual Treatment BEHAVIORAL

individual treatment

Clinical Hypnosis - Individual Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older; \*
• Self-reported presence of chronic pain;\*\*
• Average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week; \*\*
• Worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week;\*\*
• Duration of chronic pain 3 months or more; \*\*
• Experiences pain at least 75% of the time in the past 3 months; Those who have a hard time answering this question will be asked the following question: "Which statement best describes your pain?"
• Pain all the time, but the pain intensity varies;
• Pain most of the time with only occasional periods of being pain-free;
• Pain that comes and goes;
• Occasional pain; Participants must report experiencing pain that matches one of the first two options;\*\*
• Able to read, speak, and understand English.\*\*

You may not qualify if:

• Cognitive impairment or limitations (i.e. history of moderate to severe Traumatic Brain Injury (TBI), unresolved TBI, or other medical condition) that would interfere with a patient's ability to participate in a group involving focused attention\*.
• Current or history of diagnosis of primary psychotic or major thought disorder as listed in participant's medical record or self-reported within the past five years;\*
• Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD self-reported or noted in chart (within the past 5 years);\*
• Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) as listed in participant's medical record or self-reported within the past six months;\*
• Any behavioral issues as noted in the medical record or by a provider that would indicate the participant may be inappropriate in a group setting;\*\*\*
• Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking;\*\*
• Difficulties or limitations communicating over the telephone;\*\*
• Any planned life events that would interfere with participating in the key elements of the study.\*\*
• Reported average daily use of \>120mg morphine equivalent dose (MED). \*\*
• also verified via medical record review, as described below. \*\*verified solely via self-report, as described below; there is no medical record

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Osher Center for Integrative Medicine at Vanderbilt

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• McKernan LC, Connors EL, Ryden AM, Finn MTM, Kim A, Vandekar SN, Dmochowski RR, Reynolds WS. Clinical hypnosis can reduce lower urinary tract symptoms in individuals with chronic pain. Neurourol Urodyn. 2023 Jan;42(1):330-339. doi: 10.1002/nau.25090. Epub 2022 Nov 15.

  PMID: 36378832 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lindsey C. McKernan
• Organization: Osher Center for Integrative Medicine

lindsey.mckernan@vumc.org

615-320-7770

Study Officials

• Lindsey C McKernan, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: June 22, 2017
• Primary Completion: February 13, 2020
• Study Completion: March 13, 2020
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)