Comparison of Stress Reduction Techniques

August 1, 2016 updated by: Sara W Lazar, Massachusetts General Hospital
There are many ways to reduce stress. This study will compare 2 different programs for reducing stress. In addition to looking at how well the programs reduce stress, we will also ask questions about how these programs may be working.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Storrs, Connecticut, United States
        • University of Connecticut- Storrs
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Massachusettts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 25-50 years of age
  • Able to engage in moderate physical activity
  • Interested in being treated for stress

Exclusion Criteria:

  • Use of psychotropic medications within 6 months prior to study.
  • History of extreme physical or psychological trauma.
  • Medical conditions that would interfere with study procedures or confound results, such as diabetes, pregnancy, or paralysis.
  • Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Program 1
Behavioral: Program 1
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
Active Comparator: Program 2
Behavioral: Program 2
A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress
Time Frame: baseline to 24 weeks
Participants will complete a short questionnaire about how stressed they feel. There will be 4 time points: baseline, week 8, week 12, week 24.
baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • R34AT007197 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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