Management of Pain in Persons With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Mark Jensen, University of Washington
ClinicalTrials.gov Identifier:
NCT00621374
First received: February 12, 2008
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Pain
Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Self-Hypnosis Training (HYP)
Behavioral: Education Control (CONT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Depression- (CMDI; Nyenhuis et al., 1998) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]
  • Catastrophizing cognitions- (PCS; Sullivan et al. 1995) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]
  • Adaptive cognitions (CPAQ; McCracken et al., 2004) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]
  • Impact of Fatigue (FIS; Fisk et al. 1993) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]
  • Fatigue Severity (FSS; Krupp et al., 1989) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]
  • Health Status (SF-36; Ware et al., 1992) [ Time Frame: before treatment, after each treatment module, one month after 4th treatment modules ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Random Order 1
Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP
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 2
Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621374

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Multiple Sclerosis Society
Investigators
Principal Investigator: Mark P Jensen, Ph.D. University of Washington
  More Information

Publications:
Responsible Party: Mark Jensen, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00621374     History of Changes
Other Study ID Numbers: 32022-A, NMSS Award# PP1465
Study First Received: February 12, 2008
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Pain Management
Cognitive Behavior Therapy
Hypnosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014