- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02030093
Telephone-Based Continuing Care for Alcohol Dependence
Evaluation Study of the Effectiveness of a High- Versus Low-frequency Telephone-based and Sort Message-based (Sms) Continuing Care Provided to Patients Who Have Achieved a 12 Week In-patient Treatment for Alcohol Dependence
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background
Alcohol dependence is a major public health problem. Because of its relapsing nature of the disorder, alcohol and also drug dependence are now thought to be chronic disorders for many patients.Therefore, continuing care has become an important element in the treatment of alcohol dependence. Continuing care is referred to as ongoing care after an initial phase of intensive care and can be provided in different modalities and formats such as group counseling, telephone-based counseling, individual therapy and more. However, many substance-dependence patients do not attend any continuing care or abandon attending care to early. To approach this problem more flexible continuing care protocols that abstain from the traditional face-to-face counseling sessions have been developed to promote better adherence an improve disease management over time. Studies on continuing care revealed mixed results that depend on the duration of the intervention and the method of delivery services. Longer planned intervention and active approaches that bring the intervention to the patients seem to be more effective than traditional approaches in the management of addiction. For instance studies investigating telephone-based continuing care for patients with alcohol dependence have shown to be an effective form of step-dow treatment after a previous stabilisation treatment program and provide extended recovery support. Results revealed that telephone-based continuing care produced higher rates of abstinence than face-to-face standard continuing care, especially patient with low to moderate risk scores benefited therefrom. Furthermore, it is a feasible instrument to implement a low-budget follow-up system in routine outcome monitoring.
Objective
In this study, the investigators want to evaluate the effectiveness of a high- versus low-frequency telephone-based and a short message-based continuing care provided for patients who have achieved a 12 week in-patient treatment for alcohol dependence. The investigators hypothesize that telephone-based continuing care should help the patients to bridge the gap of an intensive in-patient treatment to out-patient environment and working life.
Methods
320 patients will be recruited through the Clinic Südhang (Bern) and the Forel Clinic (Zürich), both specialized clinics for treatment of alcohol dependency. Patients, age 18-65, will have attended a 12-week in-patient treatment program for alcohol dependency. Participants are divided in 4 groups (high-frequency-, low-frequency-, sms- and control- group) by randomization. Patients of the high-frequency and sms group will be contacted 9 times during the first 6 months while the low-frequency group will be called 2 times and the control group will not be contacted. All 4 groups are contacted after 6 months and 12 months. The telephone continuing care consists of several cognitive-behavioral therapy components and includes monitoring of substance use status and progress towards identified goals, identification of current and anticipated high risk situations as well as development and rehearsal of improved coping behaviors. Each call lasts approximately 15 minutes.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Bern, Schweiz, 3000
- Dep. of Psychiatric Neurophysiology, Bern University Hospital
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Alcohol dependency
- 12-week in-patient treatment
- At least six month of abstinence after treatment
- Written informed consent
Exclusion Criteria
- Use of illegal drugs
- Continued in-patient treatment
- Cognitive impairment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
High-frequency telephone-based continuing care
|
Telephone-based continuing care wil be provided to patients in different frequency
|
Low-frequency telephone-based continuing care
|
Telephone-based continuing care wil be provided to patients in different frequency
|
SMS group
|
Telephone-based continuing care wil be provided to patients in different frequency
|
Kontrolgruppe
|
Telephone-based continuing care wil be provided to patients in different frequency
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of days of alcohol abstinence
Tidsramme: Six months
|
Six months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of days of alcohol abstinence
Tidsramme: One year
|
One year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Leila Maria Soravia, Dr. phil., University of Bern
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 077/13
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