Reducing Depressive Symptoms in Systemic Lupus Erythematosus

Study Overview
=================
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.

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.

Official Title
-----------------
Reducing Depressive Symptoms in Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Behavioral: Mind-Body Skills Training (MBST)
* Behavioral: Supportive Counseling (SC)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Skills Training<br>This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices. | Behavioral: Mind-Body Skills Training (MBST)<br>* 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.<br>|
| Active Comparator: Supportive Counseling<br>This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice. | Behavioral: Supportive Counseling (SC)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Health-related quality of life (SF-12 health survey) |  | approximately 1 year following the 8 session intervention |