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

April 8, 2010
June 10, 2014
November 2009
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01120652 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Reducing Depressive Symptoms in Systemic Lupus Erythematosus
Reducing Depressive Symptoms in Systemic Lupus Erythematosus

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • 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.
  • 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.
  • Experimental: Mind-Body Skills Training
    This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices.
    Intervention: Behavioral: Mind-Body Skills Training (MBST)
  • Active Comparator: Supportive Counseling
    This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice.
    Intervention: Behavioral: Supportive Counseling (SC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01120652
AR057338
No
Carol Greco, University of Pittsburgh
University of Pittsburgh
West Penn Allegheny Health System
Principal Investigator: Carol M. Greco, Ph.D. University of Pittsburgh
University of Pittsburgh
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP