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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01909921
Other study ID # 2010P001513
Secondary ID
Status Completed
Phase N/A
First received May 28, 2013
Last updated May 16, 2016
Start date January 2009
Est. completion date March 2015

Study information

Verified date May 2016
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date March 2015
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Patients receiving care through MGH-Health Centers

- a diagnosis of depression and/or anxiety

- 21 years of age or older

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Depression scales (CES-D 10) at 8 weeks Pre- and Post-Intervention (8 weeks) No
Primary Change from baseline Anxiety Scales (STAI-20) at 8 weeks Pre- and Post- Intervention (8 weeks) No
Primary Change from baseline in Perceived Stress Scale (PSS-10) at 8 weeks Pre- and Post-Intervention (8 weeks) No
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