Effectiveness of a Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients

Completed · Not applicable

Conditions studied: Depression

In brief

The goal of this research is to evaluate whether group therapy combining Relaxation Response (RR) training and Cognitive Behavioral Therapy (CBT) in a group format merits further investigation in the treatment of Major Depressive Disorder (MDD). Specifically, the primary aim of this waitlist-controlled study is to gather preliminary data evaluating the effectiveness of RR-CBT group as treatment for patients with current MDD or a history of MDD, including patients who continue to be depressed despite taking antidepressants and patients who choose not to take antidepressants due to the fear of side effects and/or for personal reasons.

Key facts

Study ID

NCT01359839

Run by

Massachusetts General Hospital

People needed

40

Starts

2010-08-01

Expected to finish

2011-12-01

Last updated by the study team

2013-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women between the ages of 18 and 65 years;
• Chinese Americans
• Satisfy DSM-IV criteria for current Major Depressive Disorder (MDD), or have a history of MDD, prior to the initiation of RR-CBT group treatment, as determined by the SCID interview;
• HAM-D-17 baseline score ≥14; and
• Have not had CBT treatment and have not started other forms of mind/body intervention in the past 3 months.

You may not qualify if…

• Patients with primary diagnosis other than MDD and/or do not have a history of MDD;
• Any history of psychosis, mania, or severe cluster B personality disorder;
• Conditions that may make it difficult to conclusively determine that depressive symptoms are the result of MDD or having a history of MDD and not some other condition, including any form of substance abuse or dependence within the last 6 months, relevant medical conditions that may be the medical basis of a depression including epilepsy, history of an abnormal EEG, severe head trauma, or stroke;
• Medical conditions that would preclude entry into a clinical trial, including serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that have not been stable for a minimum of 3 months;
• Confounding treatments, such as current ongoing treatment other than what is provided by South Cove for depression; plans to receive confounding treatments (including the treatment of endocrinopathies); or starting new mind-body interventions including Qigong, mindfulness training, muscle relaxation training, etc.;
• Electroconvulsive therapy (ECT) during the last year; and
• Current active suicidal or self-injurious potential necessitating immediate treatment.

Where it is running

• South Cove Community Health Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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