Spinal Cord Injuries Clinical Trial
— HYPCTOfficial title:
Hypnotic Cognitive Therapy During Inpatient Rehabilitation to Reduce Acute & Chronic SCI Pain: A Randomized Controlled Trial
Verified date | November 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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-related pain is frequently not responsive to medical treatment and medical treatments that are available and commonly used, such as opioids, have negative side-effects and risk of addiction. Nonpharmacological (non-medication) interventions to reduce chronic pain show promise both for individuals with SCI as well as other chronic pain conditions. Research on psychological interventions for chronic pain over the past two decades has consistently found these interventions to be more effective than no treatment, standard care, pain education, or relaxation training alone. However, many of these interventions are designed and implemented in outpatient settings after chronic pain has already developed. The development of early, effective, and preventative interventions to reduce the development of chronic pain has the potential to vastly improve quality of life for individuals with SCI. Having demonstrated the feasibility and acceptance of this treatment in an earlier study, the purpose of this randomized clinical trial is to compare the treatment of Hypnosis Enhanced Cognitive (HYPCT) therapy to Pain Education (ED) for reducing acute and chronic pain for individuals with new spinal cord injuries. The main goals of the study are to: - Aim 1: Test the effectiveness of HYPCT during inpatient rehabilitation for SCI compared to a ED for reducing current pain intensity. - Aim 2: Determine the post-intervention impact of HYPCT sessions compared to ED on average pain intensity. Participants will be asked to: - Complete 4 surveys over seven months - Complete pre and post treatment pain assessments for each of 4 treatment/control sessions Participants will be assigned to one of two groups for treatment and receive either: - 4 Hypnotic Cognitive therapy sessions or - 4 Pain Education sessions
Status | Enrolling by invitation |
Enrollment | 88 |
Est. completion date | May 15, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 85 Years |
Eligibility | Inclusion Criteria: - diagnosis of SCI at any level or severity - currently admitted to IPR at Harborview Medical Center - moderately intense pain - evidences an ability to read and speak English Exclusion Criteria: - severe cognitive impairment - presence or history of mental health problems that would require referral for more intensive treatment or complicate hypnotic treatment - suicide attempt within the past 6 months - current, active suicidal ideation, plan, or intent - unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | The Craig H. Neilsen Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency of Independent Practice | Self-report of number of practice sessions | 1 time per week for 4 weeks, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Other | UW-CAP Short Form (Pain Catastrophizing) | The UW-CAP is intended measure an individual's level of pain catastrophizing. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Other | Chronic Pain Acceptance Scale (Pain Acceptance) | Chronic Pain Acceptance Scale (Pain Acceptance) has been designed to measure acceptance of pain. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Other | UW-PRSE Short Form (Pain Related Self-Efficacy) | The UW-PRSE is intended measure an individual's level of pain related self-efficacy. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Other | Patient Global Impression of Improvement (PGI-I) | The Patient Global Impression of Improvement (PGI-I) is an instrument designed to measure a patients interpretation of symptom changes following intervention. | 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Other | Benefit, Satisfaction, and Willingness (BSW) | The BSW is a useful tool to capture patients' global impressions of three key elements of treatment outcome: a perceived benefit, satisfaction with treatment, and the willingness to continue treatment | 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Primary | 0-10 Numerical Rating Scale of Pain change score (Decrease in Pain following live Session with Therapist) | 0 - 10, self-reported rating of pain. Possible scores range from 0 (no pain) to 10 (pain as bad as you can imagine) | 2 times per week for 4 weeks | |
Primary | 0-10 Numerical Rating Scale of Pain (Pain Relief following Practice Sessions) | 0 - 10, self-reported rating of pain. Possible scores range from 0 (no pain) to 10 (pain as bad as you can imagine) | 1 time per week for 4 weeks | |
Primary | Self-reported estimate of amount of time post therapy session that pain relief persists | Minutes and/or hours after therapy that pain relief persists | 1 time per week for 4 weeks | |
Primary | Self-reported estimate of amount of time post practice session that pain relief persists | Minutes and/or hours after practice session that pain relief persists | 1 time per week for 4 weeks | |
Primary | 0-10 Numerical Rating Scale of Pain (Weekly average pain intensity) | 0 - 10, self-reported rating of pain. Possible scores range from 0 (no pain) to 10 (pain as bad as you can imagine) | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Secondary | PROMIS Pain Interference Short Form | The PROMIS Pain Interference measures the self-reported consequences of pain on relevant aspects of a person's life. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Secondary | PHQ-9 | Patient Health Questionnaire is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Secondary | PROMIS Anxiety short form | PROMIS Anxiety short form is a 7-item measure that assesses the pure domain of anxiety in individuals. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Secondary | PROMIS Sleep Disturbance | The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Secondary | Opioid Use from Electronic medical record review | Medication and dosage | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion) | |
Secondary | The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) | The Tobacco, Alcohol, Prescription medications, and other Substance [TAPS] Tool consists of a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year and brief assessment | 1 time upon enrollment, time at 6 month Follow-up, 1 time at 7 month follow-up. | |
Secondary | 0-10 Numerical Rating Scale of Pain (Pain Relief following Medication Administration) | 0-10 Numerical Rating Scale of Pain | 1 time per week for 4 weeks | |
Secondary | Digit span (forward, backward, sequencing) (Working memory) | Measure ask subjects to count forward, backwards, and with different sequencing. | 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up. |
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