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

Spinal Cord Injuries Clinical Trial

— HYPCT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05047120
• Other study ID #: STUDY00009601
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: May 15, 2026

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Spinal Cord Injuries
• Spinal Cord Injury, Acute
• Wounds and Injuries

Intervention

Behavioral:
• Hypnosis enhanced cognitive behavioral therapy
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 Education
This therapy entails subjects learning about the causes, mechanisms, and ways to reduce pain associated with a new spinal cord injury.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

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.