Guided and Unguided Internet Treatment for Problematic Alcohol Use
31. august 2015 opdateret af: Anne H Berman, Karolinska Institutet
Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study
The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life.
80 participants were recruited entirely online from an open access website and randomized into three different groups.
All participants had access to the same self-help program.
However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Stockholm, Sverige, 11364
- Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- ≥ 18 years
- access to the Internet
- problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale
Exclusion Criteria:
• not adequately fluent in Swedish
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Choice
A self help program consisting of 8 modules.
Patients will have access to therapist support through either messages or chat sessions
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A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions
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Eksperimentel: Messages
A self help program consisting of 8 modules.
Patients will have access to therapist support through messages
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A self help program consisting of 8 modules and access to therapist guidance through messages
|
|
Aktiv komparator: Self help
A relapse intervention program consisting of 8 modules.
Patients will have no access to therapist support
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A self help program consisting of 8 modules
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time Line Follow Back (TLFB)
Tidsramme: Baseline and 10 weeks
|
Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption
|
Baseline and 10 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT)
Tidsramme: Baseline and 10 weeks
|
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
|
Baseline and 10 weeks
|
|
Hamilton Anxiety and Depression Scale (HADS)
Tidsramme: Baseline and 10 weeks
|
Change in total HADS score, as a summarized measure of depression and anxiety, respectively
|
Baseline and 10 weeks
|
|
EQ5
Tidsramme: Baseline and 10 weeks
|
Change in total EQ5 score, as a summarized measure of quality of life
|
Baseline and 10 weeks
|
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WHOQOL-BREF
Tidsramme: Baseline and 10 weeks
|
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
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Baseline and 10 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anne H Berman, PhD, Karolinska Institutet
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.
- Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 2016.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2012
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
26. februar 2015
Først indsendt, der opfyldte QC-kriterier
3. marts 2015
Først opslået (Skøn)
10. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. september 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012/1761-31/5
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .