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- Klinische proef 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Mark Rzeszutek, PhD
- Telefoonnummer: 859-323-5264
- E-mail: mark.rzeszutek@uky.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Actieve vergelijker: 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. |
|
Experimenteel: 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. |
|
Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Alcohol Use
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 117103
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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