Reducing Depressive Symptoms in Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
West Penn Allegheny Health System
Information provided by (Responsible Party):
Carol Greco, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01120652
First received: April 8, 2010
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The purpose of this randomized controlled trial is to evaluate the efficacy of a Mind-Body Skills Training intervention for improving mental and physical health in patients with Systemic Lupus Erythematosus (SLE) who have comorbid depressive symptoms.


Condition Intervention
Systemic Lupus Erythematosus
Behavioral: Mind-Body Skills Training (MBST)
Behavioral: Supportive Counseling (SC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Depressive Symptoms in Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Center for Epidemiologic Studies Depression scale (CESD) [ Time Frame: approximately 1 year following the 8 session intervention ] [ Designated as safety issue: No ]
    The CESD is a self report questionnaire designed to assess depressive symptoms.


Secondary Outcome Measures:
  • Pain (Multidimensional Pain Inventory - Pain Severity scale) [ Time Frame: approximately 1 year following the 8 session intervention ] [ Designated as safety issue: No ]
    The MPI Pain Severity scale is a 3 item self report instrument to assess current and past week pain severity

  • Fatigue (PROMIS - fatigue scale - short form) [ Time Frame: approximately 1 year following the 8 session intervention ] [ Designated as safety issue: No ]
    The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form scale assesses past week fatigue.

  • Health-related quality of life (SF-12 health survey) [ Time Frame: approximately 1 year following the 8 session intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mind-Body Skills Training
This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices.
Behavioral: Mind-Body Skills Training (MBST)
This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices. MBST is provided in 8 individual sessions, each lasting approximately one hour. Ideally, sessions take place on a weekly basis, so that the intervention phase of the study lasts for approximately two months.
Active Comparator: Supportive Counseling
This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice.
Behavioral: Supportive Counseling (SC)
This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice. SC is provided in 8 individual sessions, each lasting approximately one hour. Ideally, sessions take place on a weekly basis, so that the intervention phase of the study lasts for approximately two months.

Detailed Description:

Systemic lupus erythematosus (SLE) is a chronic, multisystemic inflammatory disease that is frequently associated with significant psychological suffering. Building upon our team's strengths in lupus biomedical research and behavioral interventions, we propose to study a non-pharmacologic intervention to improve mental and physical health of patients with SLE and co-morbid depression.

In this project, entitled, Reducing Depressive Symptoms in SLE, we will investigate the efficacy of an innovative non-pharmacologic intervention, Mind-Body Skills Training (MBST) for improving mental and physical health outcomes in SLE in a randomized controlled trial (RCT). MBST is a novel approach that combines cognitive-behavioral therapy methods, mind-body relaxation skills, and mindfulness components, each of which is beneficial for reducing pain and/or distress in other inflammatory conditions. We will assign 150 SLE patients with depressive disorder or subsyndromal depression to MBST or to a supportive counseling control condition. The primary specific aims of the project are to evaluate the effects of the 8-session MBST program on 1) mental health (depression) and 2) physical health (pain, fatigue, and health-related quality of life). Additionally we will explore the effects of the MBST intervention on 1) novel SLE biomarkers of inflammation and immune function: cell-bound complement activation products, developed at our site, 2) measures of SLE disease activity, and we will explore 3) potential treatment modifiers and mediators: baseline pain and socioeconomic status, and self-efficacy and perceived stress. We will evaluate health outcomes after the interventions and at 6- and 12-months follow-up.

SLE is one of the most complex autoimmune diseases, with one of the highest rates of depression. The MBST intervention has strong potential for addressing the unique physical manifestations and mental suffering in this patient group, and may have broad impact on distressed patients with other debilitating chronic diseases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SLE according to 1997 updated SLE criteria (Hochberg 1997)
  • Women and men of all races/ethnic groups age 18 and over
  • Able to speak and read English
  • Willing to be randomized to either MBST or SC and attend sessions
  • Medications stable for at least one month
  • Dose of prednisone or equivalent < 15 mg per day
  • PHQ-9 score > or = 9
  • BILAG classification B, C, D, or E: indicating a level of SLE activity not requiring new or increased medication
  • CES-D score > or = 16
  • QIDS-C endorsement of subsyndromal or greater depression symptoms
  • Not currently seeking psychiatric disability benefits

Exclusion Criteria:

  • BILAG A, indicating new SLE flare requiring an immediate dose adjustment or addition of corticosteroid or immunosuppressant treatment.
  • Uncontrolled medical condition (e.g., severe infection) that is determined by the research physicians to put the participant at undue risk or to interfere with ability to participate in the study.
  • Psychosis, bipolar disorder, actively suicidal or otherwise requiring immediate psychiatric treatment, as determined by diagnostic interview (SCID).
  • Current skills-based psychotherapy. However, if patients are currently receiving supportive psychotherapy and are willing to suspend this for the duration of the intervention period, they may enroll in the study.
  • Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120652

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
West Penn Allegheny Health System
Investigators
Principal Investigator: Carol M. Greco, Ph.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Carol Greco, Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01120652     History of Changes
Other Study ID Numbers: AR057338
Study First Received: April 8, 2010
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014