NCT01770587

Brief Summary

An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

6.6 years

First QC Date

January 14, 2013

Last Update Submit

February 27, 2020

Conditions

InsomniaSuicidal Ideation

Keywords

InsomniaSleepBehavioral MedicineSuicideSuicidal Ideation

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation

    Change from Baseline in Suicidal Ideation at 8 weeks

Study Arms (1)

Behavioral Insomnia Treatment

EXPERIMENTAL

Brief Behavioral Insomnia Treatment

Behavioral: Behavioral Insomnia Treatment

Interventions

Behavioral Insomnia TreatmentBEHAVIORAL
Behavioral Insomnia Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Age 18 or older * Clinically significant sleep disturbances * Diagnosis of depression

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Stanford University, Dept. of Psychiatry and Behavioral Sciences

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSuicidal IdeationSuicide

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Rebecca A Bernert, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 18, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

US(1)