- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771965
Increasing Treatment Seeking Among Suicidal Veterans Calling the Crisis Line
July 14, 2017 updated by: VA Office of Research and Development
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.
Study Overview
Detailed Description
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.
This randomized controlled trial will recruit 80 Veterans who report current suicidal ideation at the time of the Crisis Line call and are resistant to seeking behavioral health treatment.
Half of the participants will receive the brief, individualized CB intervention and half will receive standardized procedures from VA's Crisis Line (i.e., usual care).
The effectiveness of the intervention will be tested on 1) attitudes toward behavioral health treatment rates, and 2) initiation of and adherence to treatment (assessed by the number of sessions attended).
The investigators will also assess the impact of the intervention on suicidal ideation (SI) and explore the impact on the most common symptoms observed in Veteran suicide decedents (e.g., depression).
Study Type
Interventional
Enrollment (Actual)
19
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
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New York
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Canandaigua, New York, United States, 14424
- Canandaigua VA Medical Center, Canandaigua, NY
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Vermont
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White River Junction, Vermont, United States, 05009-0001
- White River Junction VA Medical Center, White River Junction, VT
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion criteria for the study are as follows:
- 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.
Exclusion Criteria:
Exclusion criteria are being judged by the Crisis Line responder to show:
- debilitating cognitive impairment
- active psychosis or mania
- acute alcohol or drug intoxication
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
No intervention.
|
|
|
Experimental: CB Intervention
Cognitive Behavioral one-on-one single session administered by phone
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Treatment Engagement (Number of Participants Entering Treatment)
Time Frame: 30 days after baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tracy A. Stecker, PhD, White River Junction VA Medical Center, White River Junction, VT
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
October 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
December 21, 2012
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Actual)
July 26, 2017
Last Update Submitted That Met QC Criteria
July 14, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 11-298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.