AzTrials
AzTrials

Spinal Cord InjuriesHYPCTNCT05047120

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

A study testing Hypnosis enhanced cognitive behavioral therapy and Pain Education in people with Spinal Cord Injuries and Pain, Chronic, run by University of Washington at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 85 years
What is being tested?
Hypnosis enhanced cognitive behavioral therapy and Pain Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
18 Sep 2023to 30 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Hypnotic Cognitive Therapy During Inpatient Rehabilitation to Reduce Acute & Chronic SCI Pain: A Randomized Controlled 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-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:

Read more
  • 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
Read the detailed description

The purpose of this study is to see if a novel psychotherapy is helpful for reducing pain in patients who been recently diagnosed with a spinal cord injury (SCI). This therapy is an in-person hypnosis enhanced cognitive therapy designed to help people with a recent SCI cope with the pain that may come with that injury. Hypnosis enhanced cognitive therapy will be compared to pain education. Pain education is a semi-standard course which instructs patients with SCI about the types, causes, and usual treatments for pain associated with SCI. This study will be conducted with newly diagnosed patients completing their initial inpatient rehabilitation treatment at Harborview Medical Center in Seattle, WA.

Subjects who meet eligibility criteria and consent to take part in this study will be randomly assigned to one of two groups. One is hypnosis enhance cognitive therapy (HYPCT) group and the other is the pain education (ED) group. Subjects cannot choose which group to be in.

Hypnosis Enhance Cognitive Therapy Group:

Participants assigned to this group will work with a psychologist (PhD) who will provide them with HYPCT. There will be 4 therapy sessions spread out over the duration of the inpatient stay or at least weekly. Sessions will take place in patient hospital rooms and last approximately one hour. Patients will learn some new information and skills to better cope with pain. Sessions will include a brief hypnosis to help patients think about pain in ways that will reduce their experience of pain. During hypnosis, patients spend a lot of time relaxing and listening to the sound of the psychologist's voice. We will record these hypnosis exercises so that patients can listen to them in between sessions with the psychologist.

Pain Education Group:

Participants assigned to this group will work with a psychologist (PhD) who will provide them with ED. There will be 4 education sessions spread out over the duration of the inpatient stay or at least weekly. Sessions will take place in the patient hospital rooms and last approximately one hour. Patients will be educated about pain, including its causes, neurophysiology, nature, and impact. There may be both general pain information as well as information tailored to the SCI specific symptoms. These will be interactive and patients will discuss the content with the therapist. Patients may listen to audio recordings, review educational information and think about what they learned between sessions. Upon completing the study, everyone in the pain education group will be offered the 6 standardized hypnosis audio recordings provided to the HYPCT group. ED group will be asked to complete a survey one month after receiving the standard hypnosis recordings.

Both groups will be asked to complete a baseline survey asking about their demographics, health, and pain. A second survey will be completed after completion of the treatment sessions (HYPCT and ED), a survey will be completed 6 months after that, and then a final survey one month later (at approximately 7 months). The surveys will ask questions about the patient's pain, the treatment of their pain, mood, and sleep quality. A trained research assistant will administer the surveys in person during the rehabilitation hospital stay and by telephone after discharge. These surveys will each take 30-45 minutes. For both groups, before and after each session, patients will be asked about their pain levels and relief. This should take less than 2 minutes.

Being tested
Hypnosis enhanced cognitive behavioral therapy, Pain Education
Keywords
Behavioral: Hypnotic Cognitive Therapy (HYPNOCT), spinal cord injury
Medical subject headings
Spinal Cord Injuries, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypnosis enhanced cognitive behavioral therapyBehavioural

    Also called HYPCT

    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.

  • Pain EducationBehavioural

    Also called ED

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

Study groups in NCT05047120
Study groupRoleWhat they receive
Hypnosis Enhanced Cognitive TherapyExperimentalThis arm will receive 4 sessions of hypnosis enhanced cognitive therapy for pain. Subjects will receive recordings of sessions for practice between therapist sessions.
Receives: Behavioral: Hypnosis enhanced cognitive behavioral therapy
Pain EducationActive comparatorThis arm will receive 4 sessions of spinal cord injury pain education. Subjects will receive pain education materials for review between therapist sessions.
Receives: Behavioral: Pain Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 times per week for 4 weeks

  2. 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)

    Measured: 1 time per week for 4 weeks

  3. Self-reported estimate of amount of time post therapy session that pain relief persists

    Minutes and/or hours after therapy that pain relief persists

    Measured: 1 time per week for 4 weeks

  4. 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

    Measured: 1 time per week for 4 weeks

  5. 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)

    Measured: 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)
  1. PROMIS Pain Interference Short Form

    The PROMIS Pain Interference measures the self-reported consequences of pain on relevant aspects of a person's life.

    Measured: 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.

  2. PHQ-9

    Patient Health Questionnaire is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings.

    Measured: 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.

  3. PROMIS Anxiety short form

    PROMIS Anxiety short form is a 7-item measure that assesses the pure domain of anxiety in individuals.

    Measured: 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.

  4. PROMIS Sleep Disturbance

    The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.

    Measured: 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.

  5. Opioid Use from Electronic medical record review

    Medication and dosage

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

  6. 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

    Measured: 1 time upon enrollment, time at 6 month Follow-up, 1 time at 7 month follow-up.

  7. 0-10 Numerical Rating Scale of Pain (Pain Relief following Medication Administration)

    0-10 Numerical Rating Scale of Pain

    Measured: 1 time per week for 4 weeks

  8. Digit span (forward, backward, sequencing) (Working memory)

    Measure ask subjects to count forward, backwards, and with different sequencing.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start18 Sep 2023
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047120
Sponsor's protocol ID
STUDY00009601
Acronym
HYPCT
Status last verified
Apr 2026
First submitted
24 Aug 2021
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37364685

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis enhanced cognitive behavioral therapy and Pain Education in people with Spinal Cord Injuries and Pain, Chronic, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

0-10 Numerical Rating Scale of Pain change score (Decrease in Pain following live Session with Therapist) (time frame: 2 times per week for 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047120, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in