Chronic Pain Skills Study – Vanderbilt University Medical Center

Overview

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 1) feasibility of conducting hypnosis in this setting 2) impact of group hypnosis on pain and 3) how participants' responsiveness to hypnosis impacts treatment outcome.

Full Title of Study: “Chronic Pain Skills Study – Vanderbilt University Medical Center”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2020

Interventions

  • Behavioral: Clinical Hypnosis – Group Treatment
    • group treatment
  • Behavioral: Clinical Hypnosis – Individual Treatment
    • individual treatment

Arms, Groups and Cohorts

  • Experimental: Clinical Hypnosis – Group Treatment
    • 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.
  • Experimental: Clinical Hypnosis – Individual Treatment
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • change in pain intensity
    • Time Frame: baseline and 6 months
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. 18 years of age or older; *

2. Self-reported presence of chronic pain;**

3. Average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week; **

4. Worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week;**

5. Duration of chronic pain 3 months or more; **

6. 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?"

1. Pain all the time, but the pain intensity varies;

2. Pain most of the time with only occasional periods of being pain-free;

3. Pain that comes and goes;

4. Occasional pain; Participants must report experiencing pain that matches one of the first two options;**

7. Able to read, speak, and understand English.**

Exclusion Criteria

1. 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*.

2. 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;*

3. Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD self-reported or noted in chart (within the past 5 years);*

4. 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;*

5. 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;***

6. 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;**

7. Difficulties or limitations communicating over the telephone;**

8. Any planned life events that would interfere with participating in the key elements of the study.**

9. 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lindsey Mckernan, Assistant Professor – Vanderbilt University Medical Center
  • Overall Official(s)
    • Lindsey C McKernan, Ph.D., Principal Investigator, Vanderbilt University Medical Center
  • Overall Contact(s)
    • Lindsey C McKernan, Ph.D., (615) 875-9990, research.ocim@vanderbilt.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.