Depression and Anxiety Reduction Treatment for Suicide (DARTS)
18. juni 2018 opdateret af: Norman Schmidt, Florida State University
Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities
The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors.
The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms.
Eligible individuals will be randomized to one of several conditions.
In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG.
Some participants will also be asked to complete four additional EEG assessments.
In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Tallahassee, Florida, Forenede Stater, 32304
- Florida State University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- At or above community sample mean on ASI-3
- At or above community sample mean on INQ-R
- English speakers
- 18 years of age or older
Exclusion Criteria:
- Significant medical illness
- Current substance dependence
- Current or past psychotic-spectrum disorders
- Uncontrolled bipolar disorder
- Serious suicidal intent that warranted immediate treatment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Anxiety Risk Reduction
The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS).
The psychoeducational component will focus on the nature of stress and its effect on the body.
Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.
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Eksperimentel: Mood Risk Reduction
The mood risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for perceived burdensomeness and thwarted belongingness.
The psychoeducational component will focus on dispelling myths related to burdensomeness and belongingness and describe their role in the development of mood symptoms.
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Eksperimentel: Combined Risk Reduction
The combined intervention will involve all of the interventions in the anxiety and mood risk reduction conditions and thus will not be matched for length.
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Ingen indgriben: Repeated Contact Control
Participants assigned to the repeated contact group will be assigned a "personal" study coordinator.
The coordinator will contact them at specific intervals during the study.
The rationale for these contacts will be provided (e.g., checking in on their status and helping to administer some brief measures).
During the three weeks (corresponding to treatment session intervals for those in one of the active treatment conditions), the study coordinator will contact the participant once per week for a brief phone check in where suicide risk will be evaluated.
Participants in the control group will also meet with their study coordinator during each of the scheduled follow-up visits.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Interpersonal Needs Questionnaire (INQ)
Tidsramme: Month 6 follow-up
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The INQ is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide.
Van Orden et al. report high internal consistency coefficients for the thwarted belongingness (α=.85) and perceived burdensomeness subscales (α=.89).
In support of construct validity, both subscales were found to prospectively predict suicidal ideation.
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Month 6 follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Anxiety Sensitivity Index-3 (ASI-3)
Tidsramme: Month 6 follow-up
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The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS).
This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides.
Each subfactor is represented by six items.
The measure has shown good psychometric properties.
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Month 6 follow-up
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Beck Suicide Scale (BSS)
Tidsramme: Month 6 follow-up
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The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts.
It has demonstrated strong reliability and validity.
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Month 6 follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Norman B Schmidt, Ph.D., Florida State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Capron DW, Allan NP, Schmidt NB. The Depression Sensitivity Index: Initial Development and Tests of Convergent and Construct Validity. J Affect Disord. 2021 May 15;287:417-426. doi: 10.1016/j.jad.2021.03.051. Epub 2021 Mar 31.
- Short NA, Stentz L, Raines AM, Boffa JW, Schmidt NB. Intervening on Thwarted Belongingness and Perceived Burdensomeness to Reduce Suicidality Among Veterans: Subanalyses From a Randomized Controlled Trial. Behav Ther. 2019 Sep;50(5):886-897. doi: 10.1016/j.beth.2019.01.004. Epub 2019 Jan 24.
- Macatee RJ, Albanese BJ, Clancy K, Allan NP, Bernat EM, Cougle JR, Schmidt NB. Distress intolerance modulation of neurophysiological markers of cognitive control during a complex go/no-go task. J Abnorm Psychol. 2018 Jan;127(1):12-29. doi: 10.1037/abn0000323.
- Short NA, Boffa JW, Norr AM, Albanese BJ, Allan NP, Schmidt NB. Randomized Clinical Trial Investigating the Effects of an Anxiety Sensitivity Intervention on Posttraumatic Stress Symptoms: A Replication and Extension. J Trauma Stress. 2017 Jun;30(3):296-303. doi: 10.1002/jts.22194. Epub 2017 Jun 6.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2013
Primær færdiggørelse (Faktiske)
1. september 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
20. juli 2013
Først indsendt, der opfyldte QC-kriterier
10. september 2013
Først opslået (Skøn)
13. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- W81XWH-10-2-0181 (Department of Defense)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .