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Management of Pain in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)

Cognitive Behavioral Therapy (CBT)

Self-Hypnosis Training (HYP)

Education Control (CONT)

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Pain Management, Cognitive Behavior Therapy, Hypnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Random Order 1

Random Order 2

Arm Description

Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP

Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP

Outcomes

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.

Secondary Outcome Measures

Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)

Depression- (CMDI; Nyenhuis et al., 1998)

Catastrophizing cognitions- (PCS; Sullivan et al. 1995)

Adaptive cognitions (CPAQ; McCracken et al., 2004)

Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)

Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994)

Impact of Fatigue (FIS; Fisk et al. 1993)

Fatigue Severity (FSS; Krupp et al., 1989)

Health Status (SF-36; Ware et al., 1992)

Full Information

NCT ID

NCT00621374

First Posted

February 12, 2008

Last Updated

January 14, 2013

Sponsor

University of Washington

Collaborators

National Multiple Sclerosis Society

1. Study Identification

Unique Protocol Identification Number

NCT00621374

Brief Title

Management of Pain in Persons With Multiple Sclerosis

Official Title

Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Pain

Keywords

Pain Management, Cognitive Behavior Therapy, Hypnosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Random Order 1

Arm Type

Experimental

Arm Description

Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP

Arm Title

Random Order 2

Arm Type

Experimental

Arm Description

Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy (CBT)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Self-Hypnosis Training (HYP)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Education Control (CONT)

Intervention Description

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).

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)

Time Frame