Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01771965
Other study ID # IIR 11-298
Secondary ID
Status Completed
Phase Phase 2
First received December 21, 2012
Last updated September 1, 2016
Start date October 2014
Est. completion date January 2016

Study information

Verified date September 2016
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
CB Intervention
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.

Locations

Country Name City State
United States Canandaigua VA Medical Center, Canandaigua, NY Canandaigua New York
United States White River Junction VA Medical Center, White River Junction, VT White River Junction South Carolina

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 and 60 days after baseline No
See also
  Status Clinical Trial Phase
Completed NCT04127292 - Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Recruiting NCT05423483 - Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents Phase 2
Completed NCT03272048 - Identifying Effective Approaches to Counseling on Firearm Safety N/A
Completed NCT05514587 - Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
Enrolling by invitation NCT05639426 - Preventing Youth Violence Through Building Equitable Communities N/A
Completed NCT03703128 - Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT06349915 - A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents N/A
Completed NCT02718248 - Ottawa Suicide Prevention in Men Pilot Study N/A
Completed NCT02094898 - Ketamine for Depression and Suicide Risk Phase 2
Completed NCT01594138 - Linguistic Characteristics of Suicidal Patients in the Emergency Department N/A
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Completed NCT00604097 - Preventing Youth Suicide in Primary Care: A Family Model Phase 3
Completed NCT00387855 - An Evaluation of the SOS (Suicide Prevention) Program N/A
Recruiting NCT03519802 - Evaluation of Cognitive Function in a Suicidal Crisis
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT03030924 - Wearable Suicidal Early Warning System for Adolescents