Hypnotic Cognitive Therapy Reduce Acute & Chronic SCI Pain in Inpatient Rehabilitation

Psychosocial/other
General health
Online since 10 November 2021, updated 979 days ago

About this trial

Chronic spinal cord injury (SCI) pain is complex and difficult to treat. For individuals with SCI, pain often begins early in the course of their SCI and continues longitudinally. Unfortunately, SCI-r...

Included participants

Gender
All
Age
16 - 85 years
Injury level
Level not specified
Time since injury
All
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Psychosocial/other

    Details

    This is a two group nonrandomized pilot study to determine the feasibility and acceptability of providing hypnosis enhanced cognitive therapy for pain management during inpatient rehabilitation after SCI. Those who consent to participate will elect to be in the intervention or quasi-control condition. Following enrollment but prior to starting treatment, participants will complete a "baseline assessment." Following the end of intervention (for the intervention group) or prior to discharge (for the measures only group), participants will complete the "follow-up assessment." A brief telephone "post-discharge assessment" will be conducted at 3 months post-discharge for those who consent to this assessment. The study has 2 primary aims. Aim 1: This trial is designed to assess if patients can be enrolled during their inpatient rehabilitation hospitalization. Feasibility will be determined by the rate of eligible patients who consent to participate. Acceptability will be determined by participant report and adverse event tracking. Hypothesis 1a: The investigators will enroll 30 adults with SCI who report moderate to severe average daily pain of at least 3 on a 0-10 scale, who meet other eligibility criteria, and consent to participate in the intervention group of the study. Hypothesis 1b: At least 80% of eligible patients will be enrolled, and at least 85% of enrolled participants will remain in the intervention and complete follow up assessment. Hypothesis 1c: Less than 5% of the participants will experience an adverse event related to the intervention, and no participants will experience an intervention related serious adverse event. Hypothesis 1d: 90% of participants will rate the intervention as satisfactory or very satisfactory. Aim 2: This trial is designed to determine if participants can fully participate in the proposed, 4 session intervention during their inpatient rehabilitation. Hypothesis 2: Participants will complete an average of 75% of scheduled therapy sessions. Exploratory Aim: While the primary focus is to assess the feasibility and acceptability of the study intervention, the investigators also plan to explore whether HYPNOCT reduces pain intensity and interference as well as opioid use. Exploratory Hypotheses: Participants who complete the intervention will report lower pain and interference immediately following the intervention compared to their baseline evaluation.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Pain

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • By invitation
    • Trial start date
    • 18 Sep 2023
    • Organisation
    • University of Washington
    • Trial recruitment status
    • By invitation
    • Trial start date
    • 18 Sep 2023
    • Organisation
    • University of Washington

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more