- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mark Rzeszutek, PhD
- Telefonnummer: 859-323-5264
- E-post: mark.rzeszutek@uky.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Aktiv 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. |
|
Eksperimentell: 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. |
|
Aktiv 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Alcohol Use
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 117103
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