Spinal Cord InjuriesNCT03857672
The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI
A study testing Hypnotic Cognitive Therapy (HYPNOCT) in people with Spinal Cord Injuries and Chronic Pain, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Chronic Pain
- What is being tested?
- Hypnotic Cognitive Therapy (HYPNOCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Medicine, Harborview Medical Center
Seattle, Washington, 98195
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Chronic Pain
- Being tested
- Hypnotic Cognitive Therapy (HYPNOCT)
- Keywords
- Behavioral, Cognitive Therapy, Self-Hypnosis
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic Cognitive Therapy (HYPNOCT)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Depression
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Subjective Disability
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Satisfaction with Life
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Community Participation
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Pain Catastrophizing
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Pain Acceptance
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Sleep Quality
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Pain Self Efficacy
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.
Measured: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Change in Global Improvement Treatment Satisfaction
Assessed using the Patient Global Impression of Importance of Change and the Patient Global Assessment of Treatment Satisfaction.
Measured: Assessed via telephone interview at 6 and 12 weeks following randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start24 Apr 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Charles Bombardier, University of Washington
- Investigators
- Charles Bombardier, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857672
- Sponsor's protocol ID
- STUDY00004135
- Other IDs
- 534402
- Status last verified
- Nov 2023
- First submitted
- 26 Feb 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bombardier CH, Mendoza ME, Thomas PA, Barber JK, Jensen MP. Hypnotic Cognitive Therapy for Chronic Pain in Spinal Cord Injury: A Randomized Controlled Trial. Neurology. 2026 Apr 28;106(8):e214836. doi: 10.1212/WNL.0000000000214836. Epub 2026 Mar 26.
PubMed 41886709
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI
- ClinicalTrials.gov ID
- NCT03857672
- Acronym / sponsor ID
- STUDY00004135
- Conditions
- Spinal Cord Injuries, Chronic Pain
- Keywords
- Behavioral, Cognitive Therapy, Self-Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotic Cognitive Therapy (HYPNOCT) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic Cognitive Therapy (HYPNOCT)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). | Behavioural | Hypnotic Cognitive Therapy (HYPNOCT) |
Primary outcome
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.
10 secondary outcomes
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 Depression
Time frame: 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 Satisfaction with Life
Time frame: 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.
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 Acceptance
Time frame: 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 Pain Self Efficacy
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 41886709Bombardier CH, Mendoza ME, Thomas PA, Barber JK, Jensen MP. Hypnotic Cognitive Therapy for Chronic Pain in Spinal Cord Injury: A Randomized Controlled Trial. Neurology. 2026 Apr 28;106(8):e214836. doi: 10.1212/WNL.0000000000214836. Epub 2026 Mar 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Bombardier, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic Cognitive Therapy (HYPNOCT) in people with Spinal Cord Injuries and Chronic Pain, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 29 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT03857672, 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 29 Nov 2023.