Reducing Depressive Symptoms in Systemic Lupus Erythematosus

NCT01120652 | Completed

• 1 other identifier: AR057338
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Center for Epidemiologic Studies Depression scale (CESD)

  The CESD is a self report questionnaire designed to assess depressive symptoms.

  approximately 1 year following the 8 session intervention

Secondary Outcomes (3)

• Pain (Multidimensional Pain Inventory - Pain Severity scale)

  approximately 1 year following the 8 session intervention

• Fatigue (PROMIS - fatigue scale - short form)

  approximately 1 year following the 8 session intervention

• Health-related quality of life (SF-12 health survey)

  approximately 1 year following the 8 session intervention

Study Arms (2)

Mind-Body Skills Training

EXPERIMENTAL

This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices.

Behavioral: Mind-Body Skills Training (MBST)

Supportive Counseling

ACTIVE COMPARATOR

This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice.

Behavioral: Supportive Counseling (SC)

Interventions

Mind-Body Skills Training (MBST) BEHAVIORAL

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.

Mind-Body Skills Training

Supportive Counseling (SC) BEHAVIORAL

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.

Supportive Counseling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• West Penn Allegheny Health System: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Carol M. Greco, Ph.D.

  University of Pittsburgh

  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: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: May 11, 2010
• Study Start: November 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)