Clinical trial NCT00621374: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Pain
Keywords: Pain Management
Cognitive Behavior Therapy
Hypnosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2008-02-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.
timeFrame: Before treatment, after each treatment module, and 1-month after the final treatment module.
Secondary outcomes:
measure: Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Depression- (CMDI; Nyenhuis et al., 1998)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Catastrophizing cognitions- (PCS; Sullivan et al. 1995)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Adaptive cognitions (CPAQ; McCracken et al., 2004)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Impact of Fatigue (FIS; Fisk et al. 1993)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Fatigue Severity (FSS; Krupp et al., 1989)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
measure: Health Status (SF-36; Ware et al., 1992)
timeFrame: before treatment, after each treatment module, one month after 4th treatment modules
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mark P Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen MP, Ehde DM, Gertz KJ, Stoelb BL, Dillworth TM, Hirsh AT, Molton IR, Kraft GH. Effects of self-hypnosis training and cognitive restructuring on daily pain intensity and catastrophizing in individuals with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2011 Jan;59(1):45-63. doi: 10.1080/00207144.2011.522892.