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Management of Pain in Persons With Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621374
First Posted: February 22, 2008
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Mark Jensen, University of Washington
February 12, 2008
February 22, 2008
January 16, 2013
February 2008
June 2009   (Final data collection date for primary outcome measure)
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff. [ Time Frame: Before treatment, after each treatment module, and 1-month after the final treatment module. ]
Same as current
Complete list of historical versions of study NCT00621374 on ClinicalTrials.gov Archive Site
  • Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Depression- (CMDI; Nyenhuis et al., 1998) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Catastrophizing cognitions- (PCS; Sullivan et al. 1995) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Adaptive cognitions (CPAQ; McCracken et al., 2004) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Impact of Fatigue (FIS; Fisk et al. 1993) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Fatigue Severity (FSS; Krupp et al., 1989) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
  • Health Status (SF-36; Ware et al., 1992) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ]
Same as current
Not Provided
Not Provided
 
Management of Pain in Persons With Multiple Sclerosis
Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis
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.
This study examined the benefits of two treatments, individually and together, for helping individuals with MS manage their pain. We conducted a time series design in which MS subjects received all four treatment conditions in two orders (randomly assigned): (1) Control (education intervention-CONT),Self-Hypnosis Training (HYP), Cognitive Behavioral Therapy (CBT), HYP-CBT(a combination of HYP and CBT) and (2) CONT, CBT, HYP, HYP-CBT. Subjects attended 16 60-minute treatment sessions conducted by one of the study's psychologists either at the UW,HMC or in the subject's home. Each subject received four treatment sessions of each treatment module listed above. Primary outcome measures were collected via the telephone and mail by research personnel blind to the treatment condition before treatment, immediately after treatment ends and one month after treatment ends. Secondary outcome measures were collected at the same assessment points via pencil and paper interviews completed by subjects.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Pain
  • Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)
    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.
  • Behavioral: Cognitive Behavioral Therapy (CBT)
    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.
  • Behavioral: Self-Hypnosis Training (HYP)
    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.
  • Behavioral: Education Control (CONT)
    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).
  • Experimental: Random Order 1
    Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)
    • Behavioral: Cognitive Behavioral Therapy (CBT)
    • Behavioral: Self-Hypnosis Training (HYP)
    • Behavioral: Education Control (CONT)
  • Experimental: Random Order 2
    Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)
    • Behavioral: Cognitive Behavioral Therapy (CBT)
    • Behavioral: Self-Hypnosis Training (HYP)
    • Behavioral: Education Control (CONT)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00621374
32022-A
NMSS Award# PP1465
No
Not Provided
Not Provided
Mark Jensen, University of Washington
University of Washington
National Multiple Sclerosis Society
Principal Investigator: Mark P Jensen, Ph.D. University of Washington
University of Washington
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP