- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03857672
The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a two-group randomized controlled trial designed to determine whether videoconferencing-delivered, hypnosis enhanced cognitive therapy (HYPNOCT) is an effective treatment for chronic SCI-related pain compared to usual care (UC). Those who consent to participate in the study will be randomized to HYPNOCT or UC. Following enrollment, but prior to starting treatment, participants will be assessed via three short (1 minute) interviews and one long (30-40 minutes) interview within a period of seven days. The assessments will also be administered immediately following the end of treatment (Post-treatment, after weekly session #6) and 6 weeks following the end of treatment (12 week follow-up) for a total of three assessment time points. The post-treatment assessments will also include additional questions related to treatment. The study has two aims.
Primary Objective: This trial is designed to assess whether videoconferencing-delivered, hypnosis enhanced cognitive therapy (HYPNOCT) is an effective treatment for chronic SCI-related pain compared to usual care (UC). Efficacy will be determined by comparing average pain intensity between the two groups at the end of the 6-week treatment phase, after controlling for baseline pain intensity and any confounders.
Hypothesis 1a: There will be a significantly greater reduction in average daily pain intensity from baseline to the end of treatment (6 weeks) in the HYPNOCT group compared to the UC group.
Secondary analyses will examine whether HYPNOCT and UC differ on pain interference, depression, sleep quality, subjective disability, health-related quality of life, and community participation at the end of treatment as well as at 12-week follow-up. Pain medications will be assessed at all time points and may be included as a covariate in outcome analyses.
Hypothesis 1b: Compared to the UC condition, the HYPNOCT condition will demonstrate significantly greater improvement on secondary outcomes (pain interference, depression, sleep quality, subjective disability, health-related quality of life, community participation, pain catastrophizing, pain acceptance, and global improvement) at 6 weeks and on the primary and secondary outcomes at 12 weeks.
Hypothesis 2: This is an exploratory hypothesis. The investigators will examine whether sex, race/ethnicity, and pain type (neuropathic vs. non-neuropathic) are effect modifiers.
Design and Outcomes A single center, randomized, single blind 160 subject efficacy study comparing videconferencing-delivered hypnosis-enhanced cognitive therapy (HCT) and usual care (UC) for the treatment of chronic SCI pain.
Interventions and Duration Participants will undergo a baseline assessment and then be randomized 1:1 to 6 weekly sessions of HYPNOCT vs. UC. Those in the HYPNOCT condition will have a weekly video-conference session with the study therapist over the course of 6 weeks. Each session will last between 45 and 60 minutes. Those in the UC condition will continue their usual care and receive no additional training from the study. The primary outcome assessment will be conducted at 6 weeks post-randomization. A follow-up assessment will be conducted in a similar manner at 12 weeks post-randomization. The primary outcome will be average pain intensity rated on a 1-10 numerical analog scale assessed four times within a one-week period.
For participants, the duration of the study will be approximately 3 to 4 months.
Sample Size and Population Researchers plan to enroll 160 participants with moderate to severe SCI-related chronic pain. Enrolled patients who complete the baseline assessments will be randomized into the HYPNOCT or UC conditions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Rehabilitation Medicine, Harborview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypnotic Cognitive Therapy (HYPNOCT)
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.
|
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).
|
No Intervention: Usual Care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Average Pain Intensity
Time Frame: Assessed via telepone four times within a 1-week period at baseline (prior to randomization), and at 6 and 12 weeks following randomization.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain interference
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in pain interference will be measured using the Brief Pain Interference Scale which examines pain interference in 7 life domains within the past week.
Responses for each item will be summed for a total raw score from 0 to 70.
Higher scores indicate more self-reported pain interference.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Depression
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in number and frequency of depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9).
Responses for each item will be summed for a total raw score from 0 to 27.
Higher scores indicate more self-reported levels of depressive symptoms.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Subjective Disability
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in subjective disability will be measured with the Sheehan Disability Scale to determine how SCI disrupts work/school, social life or family life/home responsibilities.
Responses for each item will be summed for a total score from 0 to 30.
Higher scores indicate more self-reported levels of subjective disability.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Satisfaction with Life
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
The inves will use the 10-item SCIQOL Satisfaction with Social Roles and Activities-Short Form to measure this domain because this measure was recently developed specifically for persons with SCI.
Five items are reversed coded.
All responses from items are summed into a total score.
Higher scores indicate higher self-reported satisfaction with life.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Community Participation
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
The investigators will use the SCIQOL Ability to Participate short form to measure community participation because this measure was recently developed specifically for persons with SCI.
Responses from items will be summed into a total score.
Higher scores indicate higher levels of self-reported community participation.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Pain Catastrophizing
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in pain catastrophizing will be measured with the 13-item Sullivan's Pain Catastrophizing Scale.
Responses from each item will be summed for a total score from 0 to 52.
Higher scores indicate higher levels of self-reported pain catastrophizing.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Pain Acceptance
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in pain acceptance (positive coping concept) will be measured with the 8-item Chronic Pain Acceptance Questionnaire.
Items 4, 5, 7, and 8 are reverse scored.
All item responses are summed for a total score, with higher scores denoting higher levels of self-reported pain acceptance.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Sleep Quality
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in sleep quality will be measured with the PROMIS-Sleep Disturbance Short Form 8a.
The item responses are them summed and multiplied by the total number of items in the short form.
Then this is divided by the number of items that were answered to get a prorated raw score.
The pro-rated score is converted into a T-score for each participant which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
A higher score represents more self-reported sleep disturbance.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Pain Self Efficacy
Time Frame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in pain self-efficacy will be assessed using the 4-item Patient Self-Efficacy Questionnaire (PSEQ).
Responses from each item will be summed for a total score.
Greater scores represent higher self-reported pain self-efficacy.
|
Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
|
Change in Global Improvement Treatment Satisfaction
Time Frame: Assessed via telephone interview at 6 and 12 weeks following randomization.
|
Assessed using the Patient Global Impression of Importance of Change and the Patient Global Assessment of Treatment Satisfaction.
|
Assessed via telephone interview at 6 and 12 weeks following randomization.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Bombardier, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004135
- 534402 (Other Identifier: Craig H. Neilsen Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Societa Italiana Anestesia Analgesia Rianimazione...RecruitingPost Operative Pain | Postoperative Pain, Chronic | Post Surgical PainItaly
-
University Health Network, TorontoAcademic Medical Organization of Southwestern Ontario; York University; Toronto...Not yet recruitingPain, Acute | Pain, Chronic | Post-surgical Pain | Post-Surgical Pain, ChronicCanada
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
Clinical Trials on Hypnotic Cognitive Therapy (HYPNOCT)
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH); VA Puget...Recruiting
-
Baylor UniversityNational Institutes of Health (NIH); National Center for Complementary and...CompletedHot FlashesUnited States
-
Henry M. Jackson Foundation for the Advancement...National Alliance for Research on Schizophrenia and DepressionCompletedSuicide, AttemptedUnited States
-
University of MalayaCompletedCognitive Impairment | Mild Traumatic Brain InjuryMalaysia
-
University of BergenCompleted
-
Henry M. Jackson Foundation for the Advancement...Congressionally Directed Medical Research ProgramsCompletedSuicide, AttemptedUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Laval UniversityUniversity of California, BerkeleyCompleted
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of WashingtonNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States