NCT01771965

Brief Summary

The goal of this research plan is to test the effectiveness of a brief, cognitive behavioral (CB) intervention to promote behavioral health treatment engagement among at-risk Veterans who call the Crisis Line but are resistant to behavioral health services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

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

December 21, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 26, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

December 21, 2012

Results QC Date

July 14, 2017

Last Update Submit

July 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Treatment Engagement (Number of Participants Entering Treatment)

    The investigators will be asking about service utilization since baseline interview. Zero = no mental health treatment and 1 = received mental health treatment.

    30 days after baseline

Study Arms (2)

Usual care

NO INTERVENTION

No intervention.

CB Intervention

EXPERIMENTAL

Cognitive Behavioral one-on-one single session administered by phone

Behavioral: CB Intervention

Interventions

CB InterventionBEHAVIORAL

The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior.

CB Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals 18 and older who call the Veteran Crisis Line
  • have a phone number where they can be reached, be it a land line or a cell phone
  • deemed by the Crisis Line responder to be at risk for suicide, but not imminent risk
  • refuse a referral to the SPC or to a behavioral health treatment provider during the call
  • report current suicidal ideation (SI) during the call based on administration of a standard item
  • have not been in behavioral health treatment in the past. Presence of SI will be subsequently confirmed by the research assistant using the Columbia Suicide Severity Rating Scale, a validated instrument.

You may not qualify if:

  • debilitating cognitive impairment
  • active psychosis or mania
  • acute alcohol or drug intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Canandaigua VA Medical Center, Canandaigua, NY

Canandaigua, New York, 14424, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Tracy Stecker, PhD
Organization
MUSC

Study Officials

  • Tracy A. Stecker, PhD

    White River Junction VA Medical Center, White River Junction, VT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 18, 2013

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 26, 2017

Results First Posted

July 26, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations