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.
