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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients in the Community|
- Improvement in depressive symptoms [ Time Frame: Eight Weeks ] [ Designated as safety issue: Yes ]Improvement in depressive symptoms will be assessed using the resulting scores from the questionnaire forms Q-LES-Q-SF (Quality of Life Enjoyment Satisfaction Questionnaire Short Form) and the HAM-D (Hamilton Depressive Scale).
- Score on the Q-LES-Q-SF [ Time Frame: Eight Weeks ] [ Designated as safety issue: No ]Quality of Life Enjoyment Satisfaction Questionnaire Short Form
|Study Start Date:||August 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Relaxation Response Mind Body Intervention
The Relaxation Response (RR) Mind Body Intervention Arm receives the Behavioral: Relaxation Response and Cognitive Behavioral Therapy Intervention which is a RR based Mind Body Group consisting of 1½ hour group classes held weekly for 8 weeks, in a conference room at the health center.
Behavioral: Relaxation Response and Cognitive Behavioral Therapy
This is a group format which will meet once per week and teach the techniques of cognitive behavioral therapy as well as relaxation response meditation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359839
|United States, Massachusetts|
|South Cove Community Health Center|
|Boston, Massachusetts, United States|
|Principal Investigator:||Albert Yeung, MD||Massachusetts General Hospital|
|Study Director:||Herbert Benson, MD||Massachusetts General Hospital|
|Study Director:||John Denninger, MD, PhD||Massachusetts General Hospital|
|Study Director:||Gregory Fricchione, MD||Massachusetts General Hospital|