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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Albert Yeung, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01359839
First received: May 23, 2011
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Relaxation Response and Cognitive Behavioral Therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Score on the Q-LES-Q-SF [ Time Frame: Eight Weeks ] [ Designated as safety issue: No ]
    Quality of Life Enjoyment Satisfaction Questionnaire Short Form


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359839

Locations
United States, Massachusetts
South Cove Community Health Center
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Albert Yeung, Psychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01359839     History of Changes
Other Study ID Numbers: 2009P002557
Study First Received: May 23, 2011
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014