Chronic Pain Skills Study - Vanderbilt University Medical Center
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03384953|
Recruitment Status : Completed
First Posted : December 28, 2017
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
|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.
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|