NCT02098018

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

March 18, 2014

Last Update Submit

August 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Perceived Stress

    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

Study Arms (2)

Program 1

ACTIVE COMPARATOR

Program 1

Behavioral: Program 1

Program 2

ACTIVE COMPARATOR

Program 2

Behavioral: Program 2

Interventions

Program 2BEHAVIORAL

A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.

Program 2
Program 1BEHAVIORAL

A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.

Program 1

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Connecticut- Storrs

Storrs, Connecticut, United States

Location

Massachusettts General Hospital

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

  • Braun TD, Riley KE, Kunicki ZJ, Finkelstein-Fox L, Conboy LA, Park CL, Schifano E, Abrantes AM, Lazar SW. Internalized weight stigma and intuitive eating among stressed adults during a mindful yoga intervention: associations with changes in mindfulness and self-compassion. Health Psychol Behav Med. 2021 Nov 19;9(1):933-950. doi: 10.1080/21642850.2021.1992282. eCollection 2021.

Study Officials

  • Sara Lazar, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 27, 2014

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-08

Locations