Reducing Depressive Symptoms in Systemic Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT01120652|
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Behavioral: Mind-Body Skills Training (MBST) Behavioral: Supportive Counseling (SC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing Depressive Symptoms in Systemic Lupus Erythematosus|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||September 2015|
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.
- Center for Epidemiologic Studies Depression scale (CESD) [ Time Frame: approximately 1 year following the 8 session intervention ]The CESD is a self report questionnaire designed to assess depressive symptoms.
- Pain (Multidimensional Pain Inventory - Pain Severity scale) [ Time Frame: approximately 1 year following the 8 session intervention ]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 ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120652
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Carol M. Greco, Ph.D.||University of Pittsburgh|