SuicideNCT01771965
Increasing Treatment Seeking Among Suicidal Veterans Calling the Crisis Line
A study testing CB Intervention in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- CB Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria are being judged by the Crisis Line responder to show:
- debilitating cognitive impairment
- active psychosis or mania
- acute alcohol or drug intoxication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, 14424
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
About this study
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.
Read the 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).
- Conditions
- Suicide
- Being tested
- CB Intervention
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No intervention. |
| CB Intervention | Experimental | Cognitive Behavioral one-on-one single session administered by phone Receives: Behavioral: CB Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tracy A. Stecker, PhD, Principal investigator, White River Junction VA Medical Center, White River Junction, VT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771965
- Sponsor's protocol ID
- IIR 11-298
- Status last verified
- Jul 2017
- First submitted
- 21 Dec 2012
- Last updated
- 26 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Treatment Seeking Among Suicidal Veterans Calling the Crisis Line
- ClinicalTrials.gov ID
- NCT01771965
- Acronym / sponsor ID
- IIR 11-298
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Posted 26 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No intervention. |
| CB Intervention | Experimental | Behavioral: CB InterventionCognitive Behavioral one-on-one single session administered by phone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- debilitating cognitive impairment
- active psychosis or mania
- acute alcohol or drug intoxication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB InterventionThe 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. | Behavioural | CB Intervention |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy A. Stecker, PhD principal investigator
White River Junction VA Medical Center, White River Junction, VT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CB Intervention in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Treatment Engagement (Number of Participants Entering Treatment) (time frame: 30 days after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.