DepressionNCT01909921
Retrospective Medical Record Review of Mind Body Depression Group Participants
An observational study of Depression and Anxiety, run by Massachusetts General Hospital.
Trial summary
The purpose of this study is to assess the effectiveness of a Relaxation Response Intervention for Depression offered to low income populations at Massachusetts General Hospital (MGH) - Chelsea, Revere and Charlestown health centers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression, Anxiety
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2015
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MGH-Health Center patients who have participated in the Relaxation Response Intervention for Depression groups.
Who may be able to join
- Patients receiving care through MGH-Health Centers
- a diagnosis of depression and/or anxiety
- 21 years of age or older
Who cannot join
- -
About this study
The purpose of this study is to assess the effectiveness of a Relaxation Response Intervention for Depression offered to low income populations at Massachusetts General Hospital (MGH) - Chelsea, Revere and Charlestown health centers.
Read the detailed description
This is a retrospective review of medical records. The study aims to evaluate the effects of participation in the Relaxation Response Intervention for Depression Clinical groups, on patient measures of: 1) depression, anxiety and perceived stress; 2) work productivity and activity impairment; 3) demand for, and adherence to behavioral medicine; 4) medication use for depression and/or anxiety; and 5) dose-response effects.
- Conditions
- Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Depression scales (CES-D 10) at 8 weeks
Measured: Pre- and Post-Intervention (8 weeks)
Change from baseline Anxiety Scales (STAI-20) at 8 weeks
Measured: Pre- and Post- Intervention (8 weeks)
Change from baseline in Perceived Stress Scale (PSS-10) at 8 weeks
Measured: Pre- and Post-Intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionMar 2015
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John W. Denninger, MD, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909921
- Sponsor's protocol ID
- 2010P001513
- Status last verified
- May 2016
- First submitted
- 28 May 2013
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Medical Record Review of Mind Body Depression Group Participants
- ClinicalTrials.gov ID
- NCT01909921
- Acronym / sponsor ID
- 2010P001513
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jul 2013 (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 purpose of this study is to assess the effectiveness of a Relaxation Response Intervention for Depression offered to low income populations at Massachusetts General Hospital (MGH) - Chelsea, Revere and Charlestown health centers.
Detailed description
This is a retrospective review of medical records. The study aims to evaluate the effects of participation in the Relaxation Response Intervention for Depression Clinical groups, on patient measures of: 1) depression, anxiety and perceived stress; 2) work productivity and activity impairment; 3) demand for, and adherence to behavioral medicine; 4) medication use for depression and/or anxiety; and 5) dose-response effects.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MGH-Health Center patients who have participated in the Relaxation Response Intervention for Depression groups.
Key inclusion criteria (3 listed)
- Patients receiving care through MGH-Health Centers
- a diagnosis of depression and/or anxiety
- 21 years of age or older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in Depression scales (CES-D 10) at 8 weeks
Time frame: Pre- and Post-Intervention (8 weeks)
Change from baseline Anxiety Scales (STAI-20) at 8 weeks
Time frame: Pre- and Post- Intervention (8 weeks)
Change from baseline in Perceived Stress Scale (PSS-10) at 8 weeks
Time frame: Pre- and Post-Intervention (8 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 17 May 2016.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Massachusetts General Hospital.
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 3 inclusion and 1 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in Depression scales (CES-D 10) at 8 weeks (time frame: Pre- and Post-Intervention (8 weeks)). The study lists 3 primary outcomes in all. 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 17 May 2016.