Retrospective Medical Record Review of Mind Body Depressi... | NCT01909921

Studies
Retrospective Medical Record Review of Mind Body Depression Group Participants

NCT01909921

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

156Actual

Phase

Not provided

Conditions

Depression
Anxiety

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Mar 2015Actual

First Submitted Date

May 28, 2013

First Submission Date that Met QC Criteria

Jul 24, 2013

First Posted Date

Jul 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2016

Last Update Posted Date

May 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John W. Denninger, MD, PhD, Director of Research at the Benson-Henry Institute for Mind Body Medicine, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Depression scales (CES-D 10) at 8 weeks		Pre- and Post-Intervention (8 weeks)
Change from baseline Anxiety Scales (STAI-20) at 8 weeks		Pre- and Post- Intervention (8 weeks)
Change from baseline in Perceived Stress Scale (PSS-10) at 8 weeks		Pre- and Post-Intervention (8 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving care through MGH-Health Centers
a diagnosis of depression and/or anxiety
21 years of age or older

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MGH-Health Center patients who have participated in the Relaxation Response Intervention for Depression groups.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided