Effectiveness of a Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients
Effectiveness of a Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients
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.
The Epidemiological Catchment Area Study found that the lifetime prevalence of depression
 ranged from 5-8%. A more recent assessment found that the lifetime prevalence of Major
 Depression is greater than previously estimated, with 12% of men and 21% of women suffering
 from the disorder. The point prevalence for major depression (MDD) is approximately 13% for
 women and 8% for men.

 Despite the growing number of marketed antidepressants, between 19-34% of depressed patients
 still do not respond to acute antidepressant treatment, 29-46% may fail to achieve and
 sustain a full remission, and between 15-50% will have a recurrence of depression despite
 continuous antidepressant treatment. The side effects of antidepressants are common and
 account significantly for premature treatment discontinuation.

 When a first line treatment for depression fails, clinicians often choose to increase the
 dosage, or augment with a second agent, prior to considering switching agents altogether.
 Combination of an SSRI/SNRI with other agents such as tricyclic antidepressants (TCAs) or
 lithium are examples of popular strategies. In many instances, augmentation with multiple
 psychotropic agents may not be desirable, because of risk of side effects or drug-drug
 interactions.

 In view of their benign adverse effect profiles, non-pharmacological interventions such as
 psychotherapy and mind-body intervention have been used to augment treatment for treatment
 resistant depressed patients. Preliminary studies have shown that meditation is beneficial
 for the treatment of depression.

 Research has shown that Cognitive Behavioral Therapy(CBT) is effective for both acute and
 maintenance psychotherapies. In addition, CBT has been shown not only to induce acute
 remission, but to provide prophylaxis against relapse and recurrence. CBT may impart skills
 that patients can continue to use after acute treatment ends.

 This is a pilot study to investigate the effectiveness of group therapy combining Relaxation
 Response (RR) training and CBT for depressed Chinese in the community.
Inclusion criteria

 -  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.

 Exclusion criteria

 -  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.