Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness Study

NCT02137044 | Completed

• 1 other identifier: 46597
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to: (1) test the benefits of the patient-centered collaborative care treatment approach for persons with MS who also have depression and/or pain; and also (2) test whether this approach improves quality of life, patient satisfaction, adherence to other treatments, and quality of care in the MS care system.

Conditions

Multiple Sclerosis; Pain; Depression

Keywords

multiple sclerosis; pain; depression

Outcome Measures

Primary Outcomes (2)

• Change in Control of Pain

  Control of pain is defined as either average pain severity score of less than 3 in the past week on the Brief Pain Inventory, or obtaining a 30% or greater reduction in average pain severity from baseline. Pain severity will be assessed using the Brief Pain Inventory 0-10 numerical rating scale.

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Control Of Depression

  Control of depression is defined as a reduction of at least 50% depression severity or a score of \< 0.5 on the SCL-20. Depression severity will be assessed with the Symptom Checklist Depression Subscale (SCL-20), a brief self-report measure of cognitive, emotional and somatic symptoms of depression commonly used in treatment outcome studies.

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

Secondary Outcomes (6)

• Change in Depression Severity

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Quality of Depression Care

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Pain Severity

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Disability

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Health-Related Quality of Life

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

Other Outcomes (6)

• Change in Fatigue

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Healthcare Utilization

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

• Change in Self-Efficacy

  Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment

Study Arms (2)

Collaborative Care (CC)

EXPERIMENTAL

Collaborative care (CC) is a systematic and integrated approach to improving the delivery and utilization of effective treatments for chronic pain and depression. The care was delivered through an interdisciplinary team, organized around a CC manager (CCM) who guided the patient through various aspects of care during the 16-week treatment phase. The team also included the patient's MS physician and the CC Supervisors, a group of clinicians who were experts of the study domain . The CCM offered all subjects care management, collaborative medical management, and psychosocial treatment appropriate to their problem area (i.e., pain, depression, or both) described below. If the patient had both pain and depression, he or she received care management and collaborative medical management for both.

Behavioral: Collaborative Care (CC)

Usual Care

NO INTERVENTION

Subjects assigned to usual care were informed by the CCM of their depressive and pain symptoms and that they should consult with their MS or primary care provider about possible care for these conditions. Study personnel did not make any further attempts to influence usual care participants' depression or pain management unless a psychiatric emergency arose (e.g., suicidal ideation was detected at baseline or any of the outcome assessments).

Interventions

Collaborative Care (CC) BEHAVIORAL

Collaborative care (CC) is a systematic and integrated approach to improving the delivery and utilization of effective treatments for chronic pain and depression. The care was delivered through an interdisciplinary team, organized around a CC manager (CCM) who guided the patient through various aspects of care during the 16-week treatment phase. The team also included the patient's MS physician and the CC Supervisors, a group of clinicians who were experts of the study domain . The CCM offered all subjects care management, collaborative medical management, and psychosocial treatment appropriate to their problem area (i.e., pain, depression, or both) described below. If the patient had both pain and depression, he or she received care management and collaborative medical management for both.

Collaborative Care (CC)

Eligibility Criteria

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

You may qualify if:

• Patient has a definitive diagnosis of MS confirmed by subjects' MS physician in the University of Washington (UW) MS Center;
• Patient has received care and plans to continue to receive care at the UW MS Center during enrollment period;
• Patient has access to and is able to communicate over the telephone (we will provide phone headsets if needed) to allow participation in the telehealth components of the study;
• Patient can read, speak and understand English;
• Patient is at least 18 years of age.
• Patient reports a clinically significant problem with pain and/or depression.

You may not qualify if:

• Patient represents a high suicide risk;
• Patient reports symptoms of a current psychotic disorder or diagnosis of bipolar disorder with current psychotic features at time of screening;
• Subject attends appointments more than once per month with a psychiatrist for treatment of depression;
• Patient reports planning major surgery in the next ten months;
• Patient reports alcohol or psycho-active substance dependence within past month;
• Patient has moderate to severe cognitive impairment.

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

University of Washington- Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington Medicine MS Center

Seattle, Washington, 98133, United States

Location

University of Washington-Health Sciences Building

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Ehde DM, Alschuler KN, Sullivan MD, Molton IP, Ciol MA, Bombardier CH, Curran MC, Gertz KJ, Wundes A, Fann JR. Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol. Contemp Clin Trials. 2018 Jan;64:219-229. doi: 10.1016/j.cct.2017.10.001. Epub 2017 Oct 5.

  PMID: 28987615 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Pain; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Dawn M Ehde, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: May 13, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (3)