Chronic Pain Skills Study - Vanderbilt University Medical Center
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|ClinicalTrials.gov Identifier: NCT03384953|
Recruitment Status : Completed
First Posted : December 28, 2017
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Clinical Hypnosis - Group Treatment Behavioral: Clinical Hypnosis - Individual Treatment||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Pain Skills Study - Vanderbilt University Medical Center|
|Actual Study Start Date :||June 22, 2017|
|Actual Primary Completion Date :||February 13, 2020|
|Actual Study Completion Date :||March 13, 2020|
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
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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.**
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384953
|United States, Tennessee|
|Osher Center for Integrative Medicine at Vanderbilt|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Lindsey C McKernan, Ph.D.||Vanderbilt University Medical Center|
Documents provided by Lindsey Mckernan, Vanderbilt University Medical Center:
|Responsible Party:||Lindsey Mckernan, Assistant Professor, Vanderbilt University Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 28, 2017 Key Record Dates|
|Results First Posted:||April 21, 2020|
|Last Update Posted:||April 21, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|