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

NCT05047120 | Active Not Recruiting

• 1 other identifier: STUDY00009601
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries; Pain, Chronic; Spinal Cord Injury, Acute

Keywords

Behavioral: Hypnotic Cognitive Therapy (HYPNOCT); spinal cord injury

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• PROMIS Pain Interference Short Form

  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.

• PHQ-9

  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.

• PROMIS Anxiety short form

  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.

• PROMIS Sleep Disturbance

  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.

• Opioid Use from Electronic medical record review

  1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion)

Other Outcomes (6)

• Frequency of Independent Practice

  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.

• UW-CAP Short Form (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.

• Chronic Pain Acceptance Scale (Pain Acceptance)

  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.

Study Arms (2)

Hypnosis Enhanced Cognitive Therapy

EXPERIMENTAL

This arm will receive 4 sessions of hypnosis enhanced cognitive therapy for pain. Subjects will receive recordings of sessions for practice between therapist sessions.

Behavioral: Hypnosis enhanced cognitive behavioral therapy

Pain Education

ACTIVE COMPARATOR

This arm will receive 4 sessions of spinal cord injury pain education. Subjects will receive pain education materials for review between therapist sessions.

Behavioral: Pain Education

Interventions

Hypnosis enhanced cognitive behavioral therapy BEHAVIORAL

This therapy entails subjects being induced into a state of relaxation and the receiving cognitive behavioral therapy for pain associated with a new spinal cord injury.

Also known as: HYPCT

Hypnosis Enhanced Cognitive Therapy

Pain Education BEHAVIORAL

This therapy entails subjects learning about the causes, mechanisms, and ways to reduce pain associated with a new spinal cord injury.

Also known as: ED

Pain Education

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Starosta AJ, Bombardier CH, Kahlia F, Barber J, Accardi-Ravid MC, Wiechman SA, Crane DA, Jensen MP. Feasibility of Brief, Hypnotic Enhanced Cognitive Therapy for SCI-related Pain During Inpatient Rehabilitation. Arch Phys Med Rehabil. 2024 Jan;105(1):1-9. doi: 10.1016/j.apmr.2023.06.005. Epub 2023 Jun 25.

  PMID: 37364685 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy J Starosta, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Dept. of Rehabilitation Medicine

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 16, 2021
• Study Start: September 18, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)