Management of Pain in Persons With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Pain
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP); Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Self-Hypnosis Training (HYP); Behavioral: Education Control (CONT)

• Registration Number: NCT00621374
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.	Before treatment, after each treatment module, and 1-month after the final treatment module.

Secondary Outcome Measures

Name	Time	Method
Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)	before treatment, after each treatment module, one month after 4th treatment modules
Depression- (CMDI; Nyenhuis et al., 1998)	before treatment, after each treatment module, one month after 4th treatment modules
Catastrophizing cognitions- (PCS; Sullivan et al. 1995)	before treatment, after each treatment module, one month after 4th treatment modules
Adaptive cognitions (CPAQ; McCracken et al., 2004)	before treatment, after each treatment module, one month after 4th treatment modules
Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)	before treatment, after each treatment module, one month after 4th treatment modules
Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994)	before treatment, after each treatment module, one month after 4th treatment modules
Impact of Fatigue (FIS; Fisk et al. 1993)	before treatment, after each treatment module, one month after 4th treatment modules
Fatigue Severity (FSS; Krupp et al., 1989)	before treatment, after each treatment module, one month after 4th treatment modules
Health Status (SF-36; Ware et al., 1992)	before treatment, after each treatment module, one month after 4th treatment modules

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States