The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI

NCT03857672 | Completed

• 2 other identifiers: STUDY00004135534402
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is prevalent and disabling in people with spinal cord injury (SCI). Medications alone often do not cure the pain. Pilot research suggests that training in the combination of self-hypnosis and cognitive therapy (HCT) can reduce chronic SCI-related pain. Thus far, people have learned HCT only through in-person training sessions plus home practice. The investigators think that training in HCT could be as effective if the training is done via videoconferencing. The purpose of this study is to find out whether people who are trained in HCT via videoconferencing achieve significant pain relief and other benefits compared to people who receive usual medical care (UC) for pain. Bettering our understanding of videoconferencing-delivered HYPNOCT can greatly increase treatment accessibility for individuals with SCI. Aim 1: To compare the efficacy of HYPNOCT vs. UC in adults with SCI and chronic pain. Investigators will compare the effect of the intervention on patient-reported average daily pain as measured by a 0-10 numerical rating scale. Aim 2: To examine sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) as potential effect modifiers. Hypotheses Primary study hypothesis Hypothesis 1a: There will be a significantly greater reduction in average daily pain intensity from baseline to the end of treatment in the HYPNOCT group compared to the UC group. Secondary study hypotheses Hypothesis 1b: Compared to the UC group, participants in the HYPNOCT group will show greater improvement in pain interference, depression, sleep quality, subjective disability, health-related quality of life, community participation, pain catastrophizing, pain acceptance, and global improvement. Hypothesis 2: The investigators will examine whether sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) exert a modifying effect upon outcomes.

Conditions

Spinal Cord Injuries; Chronic Pain

Keywords

Behavioral; Cognitive Therapy; Self-Hypnosis

Outcome Measures

Primary Outcomes (1)

• Change in Average Pain Intensity

  Change in average pain intensity will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.

  Assessed via telepone four times within a 1-week period at baseline (prior to randomization), and at 6 and 12 weeks following randomization.

Secondary Outcomes (10)

• Change in Pain interference

  Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.

• Change in Depression

  Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.

• Change in Subjective Disability

  Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.

• Change in Satisfaction with Life

  Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.

• Change in Community Participation

  Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.

Study Arms (2)

Hypnotic Cognitive Therapy (HYPNOCT)

EXPERIMENTAL

The HYPNOCT arm will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into the participant's belief system (note that traditional CT uses purposeful argument and logic to make these changes; in this condition the investigators add a hypnotic automaticity to this process). Thus, HYPNOCT is a hybrid intervention that overlaps with both hypnosis and CT. The participant will relax in a comfortable position and listen to the clinician speak. However, unlike standard hypnosis for pain, the post-induction suggestions will focus on changes in cognitive content and processes (as opposed to changes in sensory experience). The participants will undergo 6 weekly sessions each lasting 30-40 minutes.

Behavioral: Hypnotic Cognitive Therapy (HYPNOCT)

Usual Care

NO INTERVENTION

The study therapist will notify participants assigned to Usual Care via the participant's preferred mode of communication (phone, U.S. mail, or email). People assigned to usual care will be encouraged to continue using the health care services available to them to address their pain. The study therapist will emphasize the importance of completing the outcome assessments. The treatments usual care participants actually received will be assessed at 6 and 12 weeks.

Interventions

Hypnotic Cognitive Therapy (HYPNOCT) BEHAVIORAL

The HYPNOCT intervention will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into the participant's belief system (note that traditional CT uses purposeful argument and logic to make these changes; in this condition the investigators add a hypnotic automaticity to this process). Thus, HYPNOCT is a hybrid intervention (more than the sum of CT and hypnosis) that overlaps with both hypnosis and CT. The participant will relax in a comfortable position and listen to the clinician speak. However, unlike standard hypnosis for pain, the post-induction suggestions will focus on changes in cognitive content and processes (as opposed to changes in sensory experience).

Hypnotic Cognitive Therapy (HYPNOCT)

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older;
• diagnosis of SCI at any level or severity;
• completed inpatient rehabilitation (to ensure diagnosis and sufficient severity of SCI);
• of ≥ 4 on a 0-10 NRS of pain intensity in the last week (during both the screening and baseline examinations)
• reports that pain interferes with general activities (rates pain interference ≥ 1 on 0-10 scale)
• reports pain has been present 12 weeks or more (chronic);
• reports being able to read and speak English.
• Have access to a webcam \& microphone through either a computer, smartphone, or other internet-connected device.

You may not qualify if:

• Severe cognitive impairment defined as one or more errors on the Six-Item Screener;
• presence or history of mental health problems that would require referral for more intensive treatment or complicate hypnotic treatment (current suicidal ideation with intent or plan to harm oneself, current drug or alcohol dependence, lifetime history of bipolar disorder, psychosis, paranoid disorder based on screening questions from the M.I.N.I Neuropsychiatric Interview;
• primary chronic pain problem pre-dated SCI (e.g., chronic headache);
• has not undergone a previous medical evaluation for their pain to rule out treatable causes or undiagnosed disease (e.g., cancer);
• unstable pain medication regimen (dosage changes within the past 3 weeks);
• currently receiving CT or hypnosis for pain or has failed prior treatment with CT or hypnosis; and
• declines to provide informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Rehabilitation Medicine, Harborview Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain; Behavior

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

• Charles Bombardier, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators will conceal treatment group assignment from staff that conduct outcome assessments by: using a permuted blocked randomization with random block sizes, using secure email to inform the interventionist about group assignment, keeping the interventionist and outcome assessor physically separate and sound isolated in research spaces, and training staff in other day-to-day measures designed to maintain the blind. Research staff will be educated about the importance of maintaining the blinded conditions of the study and strategies to engage participants in maintaining the blinding as well (being clear about who participants contact regarding study questions, reminding participants about maintaining the secrecy of their condition at the beginning of all outcome related calls, having the therapist remind participants to keep their condition secret from staff assessing outcomes).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: April 24, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)