The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI

NCT03857672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-11-29

No results posted yet for this study

Summary

Chronic pain is prevalent and disabling in people with spinal cord injury (SCI). Medications alone often do not cure the pain. Pilot research suggests that training in the combination of self-hypnosis and cognitive therapy (HCT) can reduce chronic SCI-related pain. Thus far, people have learned HCT only through in-person training sessions plus home practice. The investigators think that training in HCT could be as effective if the training is done via videoconferencing. The purpose of this study is to find out whether people who are trained in HCT via videoconferencing achieve significant pain relief and other benefits compared to people who receive usual medical care (UC) for pain. Bettering our understanding of videoconferencing-delivered HYPNOCT can greatly increase treatment accessibility for individuals with SCI.

Aim 1: To compare the efficacy of HYPNOCT vs. UC in adults with SCI and chronic pain. Investigators will compare the effect of the intervention on patient-reported average daily pain as measured by a 0-10 numerical rating scale.

Aim 2: To examine sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) as potential effect modifiers.

Hypotheses Primary study hypothesis Hypothesis 1a: There will be a significantly greater reduction in average daily pain intensity from baseline to the end of treatment in the HYPNOCT group compared to the UC group.

Secondary study hypotheses Hypothesis 1b: Compared to the UC group, participants in the HYPNOCT group will show greater improvement in pain interference, depression, sleep quality, subjective disability, health-related quality of life, community participation, pain catastrophizing, pain acceptance, and global improvement.

Hypothesis 2: The investigators will examine whether sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) exert a modifying effect upon outcomes.

Conditions

Interventions

BEHAVIORAL

Hypnotic Cognitive Therapy (HYPNOCT)

The HYPNOCT intervention will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into the participant's belief system (note that traditional CT uses purposeful argument and logic to make these changes; in this condition the investigators add a hypnotic automaticity to this process). Thus, HYPNOCT is a hybrid intervention (more than the sum of CT and hypnosis) that overlaps with both hypnosis and CT. The participant will relax in a comfortable position and listen to the clinician speak. However, unlike standard hypnosis for pain, the post-induction suggestions will focus on changes in cognitive content and processes (as opposed to changes in sensory experience).

Sponsors & Collaborators

Principal Investigators

  • Charles Bombardier, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857672 on ClinicalTrials.gov