The Role of Stress in Self-Control, Coping, and Emotion R... | NCT01554501

Studies
The Role of Stress in Self-Control, Coping, and Emotion Regulation

NCT01554501

Sponsor

Yale University

Status

Completed

Last Update Posted

Nov 30, 2016Estimated

Enrollment

855Actual

Phase

Not provided

Conditions

Stress

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
5PL1DA024859-05	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 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

Nov 2007

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 12, 2012

First Posted Date

Mar 15, 2012Estimated

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

Nov 28, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

855Actual

Label	Type	Description	Intervention Names
Community sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress response and lifestyle behaviors	Study explores differences in measures of stress as they relate to self-control, coping, emotion regulation and lifestyle and health outcomes.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Biological stress responses		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ages 18-50
able to read and write

Exclusion Criteria:

Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
Pregnant women
Inability to give informed consent
Traumatic brain injury or loss of consciousness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rajita Sinha, PhD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Stress Center		New Haven	Connecticut	06519	United States

Condition Browse Module

MeSH Terms

ID	Term
D000068356	Self-Control
D000080103	Emotional Regulation

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided