Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
This study will evaluate the relationship between alcohol use, suicidal thoughts and behaviors, and behavioral economic decision-making. Participants will complete surveys over approximately 12 weeks and will be randomly assigned to receive access to a self-guide computerized cognitive behavioral therapy (CBT4CBT) program either immediately or after a waiting period. The study will compare participants with and without recent suicidal thoughts and behaviors to better understand factors associated with alcohol use and engagement with treatment.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This randomized, 2x2 factorial study will enroll adults who drink alcohol regularly and are interested in reducing or stopping their alcohol use. Participants will complete four online assessments approximately four weeks apart over a 12 week study period. The assessments include questionnaires about alcohol use, suicidal thoughts and behaviors and behavioral economic decision-making.
Participants will be randomly assigned to receive access to Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT) program either immediately after the baseline assessment or after the second follow-up assessment. The study will compare participants with and without recent suicidal thoughts and behaviors to evaluate differences in decision-making, alcohol use, and engagement with the CBT4CBT program. The results may improve understanding of factors related to alcohol use and suicide risk and help inform future interventions for individuals with alcohol use concerns.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mark Rzeszutek, PhD
- Telefonnummer: 859-323-5264
- E-Mail: mark.rzeszutek@uky.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Consume alcohol at least weekly
- Score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
- Some interest in cutting back on drinking or quitting
- Read and understand English
- Recent active/passion ideation
Exclusion Criteria:
- Score of 31 or greater on the AUDIT
- Having unmanaged psychiatric diagnoses
- Already being in treatment for alcohol use disorder at baseline
- Past month substance use other than cannabis or tobacco
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT
Participants with recent suicidal thoughts or behaviors who receive immediate access to CBT4CBT. |
Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), a self-guided computerized cognitive behavioral therapy program for alcohol use. Participants receive access either immediately following the baseline assessment or after the second follow-up assessment. |
|
Aktiver Komparator: Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT
Participants with recent suicidal thoughts or behaviors who receive delayed access to CBT4CBT after the second follow-up assessment. |
Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), a self-guided computerized cognitive behavioral therapy program for alcohol use. Participants receive access either immediately following the baseline assessment or after the second follow-up assessment. |
|
Experimental: No Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT
Participants without recent suicidal thoughts or behaviors who receive immediate access to CBT4CBT. |
Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), a self-guided computerized cognitive behavioral therapy program for alcohol use. Participants receive access either immediately following the baseline assessment or after the second follow-up assessment. |
|
Aktiver Komparator: No Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT
Participants without recent suicidal thoughts or behaviors who receive delayed access to CBT4CBT after the second follow-up assessment. |
Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), a self-guided computerized cognitive behavioral therapy program for alcohol use. Participants receive access either immediately following the baseline assessment or after the second follow-up assessment. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Alcohol Use
Zeitfenster: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
|
Change in alcohol consumption measured using the 28-day Timeline Follow-Back (TLFB). |
Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
|
|
Change in Suicidal Thoughts and Behaviors
Zeitfenster: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
|
Change in suicidal thoughts and behaviors as measured by the Colombia Suicide Severity Rating Scale (C-SSRS) |
Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 117103
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .