Reducing Depressive Symptoms in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Reducing Depressive Symptoms in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120652
• Other study ID #: AR057338
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: November 30, 2015
• Start date: November 2009
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain (Multidimensional Pain Inventory - Pain Severity scale)	The MPI Pain Severity scale is a 3 item self report instrument to assess current and past week pain severity	approximately 1 year following the 8 session intervention	No
Secondary	Fatigue (PROMIS - fatigue scale - short form)	The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form scale assesses past week fatigue.	approximately 1 year following the 8 session intervention	No
Secondary	Health-related quality of life (SF-12 health survey)		approximately 1 year following the 8 session intervention	No