Depression and Anxiety Reduction Treatment for Suicide (DARTS)
18. juni 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Tallahassee, Florida, Forente stater, 32304
- Florida State University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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 inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Norman B Schmidt, Ph.D., Florida State University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2013
Primær fullføring (Faktiske)
1. september 2017
Studiet fullført (Faktiske)
1. september 2017
Datoer for studieregistrering
Først innsendt
20. juli 2013
Først innsendt som oppfylte QC-kriteriene
10. september 2013
Først lagt ut (Anslag)
13. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. juni 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2018
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- W81XWH-10-2-0181 (Department of Defense)
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