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

Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients in the Community

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 Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Relaxation Response and Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in depressive symptoms	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).	Eight Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Q-LES-Q-SF	Quality of Life Enjoyment Satisfaction Questionnaire Short Form	Eight Weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Centers for Disease Control and Prevention
• 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

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 25, 2011

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2009P002557

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No