Clinical trial NCT03857672: The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI
Official title: The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Chronic Pain
Keywords: Behavioral
Cognitive Therapy
Self-Hypnosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2019-02-28
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Severe cognitive impairment defined as one or more errors on the Six-Item Screener;
2. 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;
3. primary chronic pain problem pre-dated SCI (e.g., chronic headache);
4. has not undergone a previous medical evaluation for their pain to rule out treatable causes or undiagnosed disease (e.g., cancer);
5. unstable pain medication regimen (dosage changes within the past 3 weeks);
6. currently receiving CT or hypnosis for pain or has failed prior treatment with CT or hypnosis; and
7. declines to provide informed consent.

Primary outcomes:
measure: Change in Average Pain Intensity
timeFrame: 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:
measure: Change in Pain interference
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Depression
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Subjective Disability
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Satisfaction with Life
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Community Participation
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Pain Catastrophizing
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Pain Acceptance
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Sleep Quality
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Pain Self Efficacy
timeFrame: Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
measure: Change in Global Improvement Treatment Satisfaction
timeFrame: Assessed via telephone interview at 6 and 12 weeks following randomization.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Rehabilitation Medicine, Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Charles Bombardier, PhD
role: PRINCIPAL_INVESTIGATOR
References: