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

NCT01359839 | Completed

• 1 other identifier: 2009P002557
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score on the Q-LES-Q-SF

  Eight Weeks

Study Arms (1)

Relaxation Response Mind Body Intervention

EXPERIMENTAL

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

Interventions

Relaxation Response and Cognitive Behavioral Therapy 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.

Relaxation Response Mind Body Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

South Cove Community Health Center

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Albert Yeung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Herbert Benson, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

• John Denninger, MD, PhD

  Massachusetts General Hospital

  STUDY DIRECTOR

• Gregory Fricchione, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 25, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

US (1)