Management of Pain in Persons With Multiple Sclerosis
Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis
2 other identifiers
interventional
22
1 country
1
Brief Summary
The purpose of this study is to see if treatments that include components of self-hypnosis training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJanuary 16, 2013
January 1, 2013
1.3 years
February 12, 2008
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.
Before treatment, after each treatment module, and 1-month after the final treatment module.
Secondary Outcomes (9)
Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)
before treatment, after each treatment module, one month after 4th treatment modules
Depression- (CMDI; Nyenhuis et al., 1998)
before treatment, after each treatment module, one month after 4th treatment modules
Catastrophizing cognitions- (PCS; Sullivan et al. 1995)
before treatment, after each treatment module, one month after 4th treatment modules
Adaptive cognitions (CPAQ; McCracken et al., 2004)
before treatment, after each treatment module, one month after 4th treatment modules
Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)
before treatment, after each treatment module, one month after 4th treatment modules
- +4 more secondary outcomes
Study Arms (2)
Random Order 1
EXPERIMENTALRandomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP
Random Order 2
EXPERIMENTALRandomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP
Interventions
There is also the possibility that the two treatments together may be even more helpful than either one alone. Because some of the patients in this study will get both CBT and self-hypnosis, we will be able to determine if each one facilitates the efficacy of the other. If the patients treated in this study report benefits, as we expect they will, then this will encourage us to design and complete a larger study to better understand how patients with MS would benefit from these treatments.
One treatment module is we will study is called "cognitive restructuring" or "cognitive-behavior therapy" (CBT). In this treatment, people learn to identify negative thoughts that make them feel bad or anxious. Such negative thoughts lead to feelings of frustration and anxiety, and can even increase the experience of pain, because they cause a person to focus more on pain. With CBT, people learn to identify and stop these thoughts, and then replace them with more reassuring ones. When they do this, they feel more relaxed and focus less on their pain. As a result, they often say that they feel much better and are less aware of pain.
Self-hypnosis (HYP) is another strategy that people can learn to manage pain. With this treatment, people learn to enter a state of focused attention, and then change how they experience pain. Although we do not yet know how hypnosis works, research has repeatedly shown that the effects are real; when people report decreases in pain with hypnosis, scans and images of the brain's activity show decreases in the parts of the brain that process pain information. With hypnosis, people are not just pretending to feel less pain, they actually do feel less pain.
The CONT condition for this study will include lectures that are interactive and are compelling and informative enough to be both (1) credible as an attentional control condition and (2) perceived as helpful to subjects. The CONT condition will not, however, include instructions in making specific cognitive or behavioral changes related to pain management. Thus, it could control for non-specific factors related to behavioral treatment, but will not impact the primary outcome measure (pain).
Eligibility Criteria
You may qualify if:
- Chronic ongoing pain (i.e., pain at all times) with an average pain intensity of at least 4/10 on 0-10 numeric rating scale
- Pain is either worse or started since the onset of other MS symptoms.
- Pain of at least six months duration.
- Reads, speaks and understands English.
- Definitive diagnosis of multiple sclerosis (MS)
- At least 18 years of age
- Recruited from a recruitment source approved by the IRB
You may not qualify if:
- Severe cognitive impairment resulting in the inability to verbally comprehend, learn, and recall new auditory verbal information, as reflected by a TICS score of 20 or less.
- Currently participating in counseling and/or psychotherapy more than once a week.
- Currently taking anti-psychotic medications
- Has been hospitalized for psychiatric reasons in the past six months
- Experiencing current active suicidal ideation.
- Has received treatment or participated in a clinical trial that involved significant elements of either CBT or hypnosis within the past year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Multiple Sclerosis Societycollaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Jensen MP, Ehde DM, Gertz KJ, Stoelb BL, Dillworth TM, Hirsh AT, Molton IR, Kraft GH. Effects of self-hypnosis training and cognitive restructuring on daily pain intensity and catastrophizing in individuals with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2011 Jan;59(1):45-63. doi: 10.1080/00207144.2011.522892.
PMID: 21104484RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark P Jensen, Ph.D.
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 12, 2008
First Posted
February 22, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
January 16, 2013
Record last verified: 2013-01