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

NCT ID: NCT01359839

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Relaxation Response and Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Albert Yeung

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Yeung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Herbert Benson, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

John Denninger, MD, PhD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Gregory Fricchione, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

South Cove Community Health Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009P002557

Identifier Type: -

Identifier Source: org_study_id