DepressionNCT01359839
Effectiveness of a Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients
A study testing Relaxation Response and Cognitive Behavioral Therapy in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Relaxation Response and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Cove Community Health Center
Boston, Massachusetts
About this study
Official title: 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.
Read the 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
- Being tested
- Relaxation Response and Cognitive Behavioral Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response and Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Relaxation Response and Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Eight Weeks
Secondary outcomes (1)
Score on the Q-LES-Q-SF
Quality of Life Enjoyment Satisfaction Questionnaire Short Form
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Albert Yeung, Massachusetts General Hospital
- Investigators
- Albert Yeung, MD, Principal investigator, Massachusetts General HospitalHerbert Benson, MD, Study director, Massachusetts General HospitalJohn Denninger, MD, PhD, Study director, Massachusetts General HospitalGregory Fricchione, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359839
- Sponsor's protocol ID
- 2009P002557
- Status last verified
- May 2013
- First submitted
- 23 May 2011
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation-Response Based Cognitive Behavioral Therapy Group for Depressed Chinese Patients in the Community
- ClinicalTrials.gov ID
- NCT01359839
- Acronym / sponsor ID
- 2009P002557
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relaxation Response Mind Body Intervention | Experimental | Behavioral: Relaxation Response and Cognitive Behavioral TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation Response and Cognitive Behavioral TherapyThis is a group format which will meet once per week and teach the techniques of cognitive behavioral therapy as well as relaxation response meditation. | Behavioural | Relaxation Response Mind Body Intervention |
Primary outcome
Improvement in depressive symptoms
Time frame: Eight Weeks
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).
1 secondary outcome
Score on the Q-LES-Q-SF
Time frame: Eight Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Yeung, MD principal investigator
Massachusetts General Hospital
Herbert Benson, MD study director
Massachusetts General Hospital
John Denninger, MD, PhD study director
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response and Cognitive Behavioral Therapy in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in depressive symptoms (time frame: Eight Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.