Cognitive-behavior Therapy for MS-Related Chronic Pain

NCT00323271 | Completed Results

• 1 other identifier: D4150-R
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with Multiple Sclerosis.

Conditions

Multiple Sclerosis

Keywords

Chronic pain; Cognitive behavioral therapy; Multiple sclerosis; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.

  baseline

• Pain Intensity

  The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.

  Baseline to Post Treatment (12 weeks)

Study Arms (2)

Arm 1

EXPERIMENTAL

Behavioral: Cognitive-behavior therapy

Behavioral: Cognitive-behavior therapy

Arm 2

ACTIVE COMPARATOR

Interventional: Educational intervention

Other: Interventional

Interventions

Cognitive-behavior therapy BEHAVIORAL

CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11).

Arm 1

Interventional OTHER

Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system.

Arm 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a confirmed diagnosis of Multiple Sclerosis,
• history of daily pain or discomfort (burning, tingling or other parenthesis) for a period of 3 months immediately prior to enrollment,
• judgment of one of the study neurologists (AL or MK) that the pain reported by the patient is either directly \[e.g., pain associated with optic neuritis and neuralgias\] or indirectly related \[e.g., pain due to painful muscle contractures and spasms\] to MS and/or its treatment (persons with pain that is judged to be entirely coincident with MS \[e.g., idiopathic low back pain\] will not be included),
• documentation of optimal pharmacological management of MS-related pain and confirmation of this judgment by one of the study neurologists,
• continued use of appropriate pharmaceuticals for the management of MS and pain, and
• continued refractory pain despite pharmaceutical intervention as described above (as determined by a pain intensity score 4 on a 0-10 numeric rating scale).

You may not qualify if:

• pending surgery or interventional anesthesiological procedures for pain,
• currently psychotic or actively suicidal or homicidal,
• current alcohol or substance abuse or dependence,
• presence of other life threatening illnesses,
• the presence of profound cognitive impairment rendering successful participation in CBT or ED impossible,
• the presence of physical disabilities resulting in an inability to attend treatment sessions and/or inability to participate in telephone interventions (e.g., severe dysarthria),
• prior or current psychological treatment for chronic pain,
• two or more documented exacerbations of MS-related symptoms during the past year, and

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (2)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Chronic Pain

Interventions

Cognitive Behavioral Therapy; Methods

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Investigative Techniques

Results Point of Contact

• Title: Robert Kerns, PhD
• Organization: VA Connecticut Healthcare System

robert.kerns@va.gov

203-932-5711

Study Officials

• Robert D. Kerns, PhD

  VA Connecticut Health Care System (West Haven)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: July 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 25, 2015
• Results First Posted: September 25, 2015

Record last verified: 2015-08

Locations

US (2)