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Management of Pain in Persons With Multiple Sclerosis

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University of Washington

Status

Completed

Conditions

Multiple Sclerosis
Pain

Treatments

Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Self-Hypnosis Training (HYP)
Behavioral: Education Control (CONT)
Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)

Study type

Interventional

Funder types

Other

Identifiers

NCT00621374
32022-A
NMSS Award# PP1465

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

22 participants in 2 patient groups

Random Order 1
Experimental group
Description:
Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP
Treatment:
Behavioral: Education Control (CONT)
Behavioral: Self-Hypnosis Training (HYP)
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)
Random Order 2
Experimental group
Description:
Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP
Treatment:
Behavioral: Education Control (CONT)
Behavioral: Self-Hypnosis Training (HYP)
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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