Chronic Pain Skills Study - Vanderbilt University Medical Center

NCT ID: NCT03384953

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-22
• Study Completion Date: 2020-03-13

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Clinical Hypnosis - Group Treatment

Intervention Type: BEHAVIORAL

group treatment

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.

Group Type: EXPERIMENTAL

Clinical Hypnosis - Individual Treatment

Intervention Type: BEHAVIORAL

individual treatment

Interventions

Clinical Hypnosis - Group Treatment

group treatment

Intervention Type: BEHAVIORAL

Clinical Hypnosis - Individual Treatment

individual treatment

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lindsey Mckernan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsey C McKernan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Osher Center for Integrative Medicine at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36378832 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

170652

Identifier Type: -

Identifier Source: org_study_id