The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI

Chronic Pain Clinical Trial

Official title:

The Efficacy of Hypnotic Cognitive Therapy for Chronic Pain in SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857672
• Other study ID #: STUDY00004135
• Secondary ID: 534402
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Rehabilitation Medicine, Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed via telepone four times within a 1-week period at baseline (prior to randomization), and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	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.	Assessed via telephone interview at baseline prior to randomization, and at 6 and 12 weeks following randomization.
Secondary	Change in Global Improvement Treatment Satisfaction	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.