Chronic Pain Skills Study - Vanderbilt University Medical Center

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Clinical Hypnosis - Group Treatment; Behavioral: Clinical Hypnosis - Individual Treatment

Detailed Description

The purpose of this pilot project is to test the efficacy and mechanisms of clinical hypnosis on chronic pain. Primary (characteristic pain intensity) and secondary (mood, quality of life) outcomes will be assessed at pre-treatment, three times during treatment, post-treatment, and at 3- and 6-month follow-up. Potential treatment moderators and mediators will also be assessed. The study will address two aims:

Aim 1: Determine the efficacy of 8 sessions of group delivered HYP training for reducing characteristic pain intensity in patients. The hypothesis associated with Aim 1 is:

Hypothesis 1: Primary Study Hypothesis. Patients receiving 8 sessions of HYP training will report significantly reduced pre- to post-treatment decreases in average pain intensity.

Aim 2 : To evaluate potential moderators (hypnotizability) associated with treatment outcomes following intervention. The hypothesis associated with Aim 2 is:

Hypothesis 2a: Hypnotizability will augment treatment outcomes such that those with higher hypnotizability will experience significantly greater treatment gains.

In addition to testing the above specific hypotheses, we will use the data obtained in this study to further explore (1) the longer-term (up to 6 months) effects of HYP and (2) additional potential moderators (e.g., treatment outcome expectancies, treatment motivation, demographic variables, pain type [neuropathic vs. nociceptive]) and mediators (pain acceptance, catastrophizing, mindfulness, therapeutic alliance, amount of skill practice between sessions) of treatment outcome.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Osher Center for Integrative Medicine at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Clinical Hypnosis - Group Treatment; group treatment
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.	Behavioral: Clinical Hypnosis - Individual Treatment; individual treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Lindsey C McKernan, Ph.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 170652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No