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Chronic Pain Skills Study - Vanderbilt University Medical Center

Primary Purpose

Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinical Hypnosis - Group Treatment

Clinical Hypnosis - Individual Treatment

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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?"
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;**
Able to read, speak, and understand English.**

Exclusion Criteria:

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

Sites / Locations

Osher Center for Integrative Medicine at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Clinical Hypnosis - Group Treatment

Clinical Hypnosis - Individual Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03384953

First Posted

December 20, 2017

Last Updated

April 13, 2020

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03384953

Brief Title

Chronic Pain Skills Study - Vanderbilt University Medical Center

Official Title

Chronic Pain Skills Study - Vanderbilt University Medical Center

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

June 22, 2017 (Actual)

Primary Completion Date

February 13, 2020 (Actual)

Study Completion Date

March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clinical Hypnosis - Group Treatment

Arm Type

Experimental

Arm Description

Arm Title

Clinical Hypnosis - Individual Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Clinical Hypnosis - Group Treatment

Intervention Description

group treatment

Intervention Type

Behavioral

Intervention Name(s)

Clinical Hypnosis - Individual Treatment

Intervention Description

individual treatment

Primary Outcome Measure Information:

Title

Change in Pain Intensity

Description

Time Frame

baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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.** Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lindsey C McKernan, Ph.D.

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Osher Center for Integrative Medicine at Vanderbilt

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Chronic Pain Skills Study - Vanderbilt University Medical Center

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