Chronic Pain Skills Study - Vanderbilt University Medical Center

Chronic Pain Clinical Trial

Official title: Chronic Pain Skills Study - Vanderbilt University Medical Center

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Pain

• NCT number: NCT03384953
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Status: Completed
• Phase: N/A
• Start date: June 22, 2017
• Completion date: March 13, 2020