- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07842588
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mark Rzeszutek, PhD
- Numero di telefono: 859-323-5264
- Email: mark.rzeszutek@uky.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Alcohol Use
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 117103
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