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Project

The efficacy of hypnotic cognitive therapy for chronic pain in SCI

Funder: Craig H Neilsen Foundation

Funding period
USD 398 K
Funding amount
Abstract
Chronic SCI pain is prevalent, disabling, and associated with lower quality of life. SCI pain is difficult to treat and often does not respond to currently available medical treatments. Therefore, additional treatments – including nonpharmacological treatments are needed to reduce pain intensity and interference in people with SCI. Ruminative, fearful, hopeless beliefs about pain (referred to as “pain catastrophizing”) have been shown to amplify SCI related pain. Cognitive therapy and self-hypnosis have been shown to reduce pain catastrophizing, pain severity, and pain interference. Moreover, preliminary research in people with multiple sclerosis or SCI showed that cognitive therapy plus self-hypnosis (HYPNOCT) has greater beneficial effects on pain intensity compared either treatment alone. The effects of HYPNOCT in these studies were moderate to large (d= 0.82, 0.66 SD). Therefore, we plan to study the efficacy of HYPNOCT to treat chronic pain in SCI. We will deliver the HYPNOCT via telephone because this method has been well received in our prior studies, and it overcomes geographical and other barriers to treatment. We will recruit adults with medically confirmed SCI from throughout the U.S. Participants will be required to have average daily pain intensity of at least 5 on a 0-10 scale. We plan to enroll 160 people to retain 128 (80%). The sample size of 128 gives us 80% power to detect an effect size of 0.50 based on an ANOVA with one primary comparison (treatment group by time interaction). Those who are eligible and provide written consent will undergo a baseline assessment followed by 1:1 randomization into the treatment versus control groups. The biostatistician will perform a centralized computer generated permuted block randomization (with variable block sizes) to balance the group sizes and conceal allocation from the staff member who will assess outcomes. Randomization will be stratified by sex (male, female) and worst pain type (neuropathic, non-neuropathic). The treatment group will receive HYPNOCT, a manualized treatment program completed in 6 weekly sessions that aims to decrease pain catastrophizing, increase a sense of control over pain, and make these cognitive reappraisals of pain happen automatically. The control group will receive usual care. The primary outcome is average pain intensity measured on a 0-10 point numerical analog scale assessed four times with in a one-week period. Secondary outcomes are pain interference, depression, sleep quality, subjective disability, health-related quality of life, community participation, pain catastrophizing, pain acceptance, global improvement, and satisfaction with treatment. All outcomes will be measured at baseline, 6, and 12 weeks. We will use mixed-effect regressions to determine whether the primary outcome, average pain intensity, improved more in the HYPNOCT group compared to the usual care group from baseline to 6 and 12 weeks after controlling for baseline pain level and any other relevant differences between the two groups. Similar analyses will be computed to determine whether there was greater improvement in HYPNOCT versus control group on the secondary outcom (CHN: PSR chn:wdg)
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System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • RCDC

    Injury (total) Accidents/Adverse Effects

  • RCDC

    Injury - Trauma - (Head and Spine)

  • RCDC

    Neurosciences

  • RCDC

    Pain Research

  • RCDC

    Pain Conditions - Chronic

  • RCDC

    Mind and Body

  • RCDC

    Spinal Cord Injury

  • RCDC

    Behavioral and Social Science

  • RCDC

    Clinical Research

  • RCDC

    Clinical Trials and Supportive Activities

  • RCDC

    Neurodegenerative

  • HRCS HC

    Neurological

  • HRCS RAC

    6.1 Pharmaceuticals

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science