Clinical trial NCT05047120: Hypnotic Cognitive Therapy Reduce Acute & Chronic SCI Pain in Inpatient Rehabilitation
Official title: Hypnotic Cognitive Therapy During Inpatient Rehabilitation to Reduce Acute & Chronic SCI Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injuries
Pain, Chronic
Spinal Cord Injury, Acute
Keywords: Behavioral: Hypnotic Cognitive Therapy (HYPNOCT)
spinal cord injury
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2021-09-16
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 0-10 Numerical Rating Scale of Pain change score (Decrease in Pain following live Session with Therapist)
timeFrame: 2 times per week for 4 weeks
measure: 0-10 Numerical Rating Scale of Pain (Pain Relief following Practice Sessions)
timeFrame: 1 time per week for 4 weeks
measure: Self-reported estimate of amount of time post therapy session that pain relief persists
timeFrame: 1 time per week for 4 weeks
measure: Self-reported estimate of amount of time post practice session that pain relief persists
timeFrame: 1 time per week for 4 weeks
measure: 0-10 Numerical Rating Scale of Pain (Weekly average pain intensity)
timeFrame: 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:
measure: PROMIS Pain Interference Short Form
timeFrame: 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.
measure: PHQ-9
timeFrame: 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.
measure: PROMIS Anxiety short form
timeFrame: 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.
measure: PROMIS Sleep Disturbance
timeFrame: 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.
measure: Opioid Use from Electronic medical record review
timeFrame: 1 time upon enrollment, 1 time after 4 weeks (HYPCT/ED Completion)
measure: The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS)
timeFrame: 1 time upon enrollment, time at 6 month Follow-up, 1 time at 7 month follow-up.
measure: 0-10 Numerical Rating Scale of Pain (Pain Relief following Medication Administration)
timeFrame: 1 time per week for 4 weeks
measure: Digit span (forward, backward, sequencing) (Working memory)
timeFrame: 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 outcomes:
measure: Frequency of Independent Practice
timeFrame: 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.
measure: UW-CAP Short Form (Pain Catastrophizing)
timeFrame: 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.
measure: Chronic Pain Acceptance Scale (Pain Acceptance)
timeFrame: 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.
measure: UW-PRSE Short Form (Pain Related Self-Efficacy)
timeFrame: 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.
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up.
measure: Benefit, Satisfaction, and Willingness (BSW)
timeFrame: 1 time after 4 weeks (HYPCT/ED Completion), 1 time at 6 month Follow-up, 1 time at 7 month follow-up.
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Amy J Starosta, PhD
role: PRINCIPAL_INVESTIGATOR
References: