The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Change in Average Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hypnotic Cognitive Therapy (HYPNOCT) (Behavioral)
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.
结局指标
主要结局
Change in Average Pain Intensity
时间窗: 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.
次要结局
- Change in Community Participation(Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.)
- Change in Global Improvement Treatment Satisfaction(Assessed via telephone interview 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 Sleep Quality(Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.)
- Change in Pain interference(Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.)
- Change in Pain Catastrophizing(Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.)
- Change in Pain Acceptance(Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.)
- Change in Pain Self Efficacy(Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.)
研究者
Charles Bombardier
Professor, School of Medicine: Rehabilitation Medicine
University of Washington