Management of Pain in Persons With Multiple Sclerosis - Full Text View

Sponsors and Collaborators:	University of Washington National Multiple Sclerosis Society
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00621374

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)

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Pilot Study of CBT and Self-Hypnosis Training for Pain in Persons With Multiple Sclerosis

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 ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Random Order 1: Experimental 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).
Random Order 2: Experimental 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).

Arms

Assigned Interventions

Random Order 1: Experimental

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).

Random Order 2: Experimental

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 will examine the benefits of two treatments, individually and together, for helping individuals with MS manage their pain. We will conduct a time series design in which up to 30 MS subjects will receive 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 will attend 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 will receive four treatment sessions of each treatment module listed above. Primary outcome measures will be collected via the telephone by research personnel blind to the treatment condition before treatment, immediately after treatment ends and one month after treatment ends.

Secondary outcome measures will be 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

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

Additional Information:

Recruitment Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Washington ( Mark P. Jensen, Ph.D., Professor )
Study ID Numbers:	32022-A, NMSS Award# PP1465
Study First Received:	February 12, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00621374 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Pain Management
Cognitive Behavior Therapy
Hypnosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Sclerosis
Pain
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 06, 2009