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Sponsors and Collaborators: |
University of Washington National Multiple Sclerosis Society |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00621374 |
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 |
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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: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Random Order 1: Experimental
Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP
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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).
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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).
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric S Weitz, BS | 1-800-377-9707 | eweitz3@u.washington.edu |
Contact: Kevin J Gertz, BA | 1-800-377-9707 | kjgertz@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Principal Investigator: Mark P Jensen, Ph.D. | |
Sub-Investigator: Dawn M Ehde, Ph.D. | |
Sub-Investigator: George H Kraft, M.D. |
Principal Investigator: | Mark P Jensen, Ph.D. | University of Washington |
Responsible Party: | University of Washington ( Mark P. Jensen, Ph.D., Professor ) |
Study ID Numbers: | 07-6255 A01, NMSS Award# PP1465 |
Study First Received: | February 12, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00621374 |
Health Authority: | United States: Institutional Review Board |
Pain Management Cognitive Behavior Therapy Hypnosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Pain Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |