Alcohol DependenceNCT02030093
Telephone-Based Continuing Care for Alcohol Dependence
An observational study of Alcohol Dependence, run by University of Bern at 1 site in Switzerland.
Trial summary
Alcohol dependency is the second most common psychiatric disorder and a major public health concern. As addictive disorders and now thought to be chronic disorders for many patients there is a need for the development of expanded treatment approaches. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Telephone-based counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 317 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Dec 2013to 12 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of the clinic Südhang (Bern) and the Forel clinic (Zürich), both specialized clinics for the treatment of alcohol dependency
Who may be able to join
- Alcohol dependency
- 12-week in-patient treatment
- At least six month of abstinence after treatment
- Written informed consent
Who cannot join
- Use of illegal drugs
- Continued in-patient treatment
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Psychiatric Neurophysiology, Bern University Hospital
Bern, 3000
About this study
Official title: 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
Alcohol dependency is the second most common psychiatric disorder and a major public health concern. As addictive disorders and now thought to be chronic disorders for many patients there is a need for the development of expanded treatment approaches. Because relapse is more often the rule than the exception the importance of continuing care after an initial phase of treatment is evident. Studies investigating telephone-based continuing care for patients with alcohol dependence have shown to be an effective form of step-down treatment after a previous stabilisation treatment program and provide extended recovery support. Therefore, the investigators hypothesize that alcohol abstinent patients who received high-frequency telephone-based or sms-based continuing care show significantly less relapses respectively more abstinent days six and twelve months after in-patient treatment compared to patients who receive low-frequency or no telephone-based continuing care.
Read the detailed description
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.
- Conditions
- Alcohol Dependence
- Being tested
- Telephone-based counseling
- Keywords
- Alcohol dependence, Telephone-based continuing care, Outcome monitoring
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based counselingBehavioural
Telephone-based continuing care wil be provided to patients in different frequency
| Study group | Role | What they receive |
|---|---|---|
| High-frequency telephone-based continuing care | High-frequency telephone-based continuing care Receives: Behavioral: Telephone-based counseling | |
| Low-frequency telephone-based continuing care | Low-frequency telephone-based continuing care Receives: Behavioral: Telephone-based counseling | |
| SMS group | SMS group Receives: Behavioral: Telephone-based counseling | |
| Control group | Control group Receives: Behavioral: Telephone-based counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of alcohol abstinence
Measured: Six months
Secondary outcomes (1)
Number of days of alcohol abstinence
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study start9 Dec 2013
- Primary completion27 Jun 2016
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila Maria Soravia, Dr. phil., Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030093
- Sponsor's protocol ID
- 077/13
- Status last verified
- Oct 2017
- First submitted
- 19 Dec 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02030093
- Acronym / sponsor ID
- 077/13
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, Telephone-based continuing care, Outcome monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 9 Dec 2013 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol dependency is the second most common psychiatric disorder and a major public health concern. As addictive disorders and now thought to be chronic disorders for many patients there is a need for the development of expanded treatment approaches. Because relapse is more often the rule than the exception the importance of continuing care after an initial phase of treatment is evident. Studies investigating telephone-based continuing care for patients with alcohol dependence have shown to be an effective form of step-down treatment after a previous stabilisation treatment program and provide extended recovery support. Therefore, the investigators hypothesize that alcohol abstinent patients who received high-frequency telephone-based or sms-based continuing care show significantly less relapses respectively more abstinent days six and twelve months after in-patient treatment compared to patients who receive low-frequency or no telephone-based continuing care.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-frequency telephone-based continuing care | – | Behavioral: Telephone-based counselingHigh-frequency telephone-based continuing care |
| Low-frequency telephone-based continuing care | – | Behavioral: Telephone-based counselingLow-frequency telephone-based continuing care |
| SMS group | – | Behavioral: Telephone-based counselingSMS group |
| Control group | – | Behavioral: Telephone-based counselingControl group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the clinic Südhang (Bern) and the Forel clinic (Zürich), both specialized clinics for the treatment of alcohol dependency
Key inclusion criteria (4 listed)
- Alcohol dependency
- 12-week in-patient treatment
- At least six month of abstinence after treatment
- Written informed consent
Key exclusion criteria (3 listed)
- Use of illegal drugs
- Continued in-patient treatment
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-based counselingTelephone-based continuing care wil be provided to patients in different frequency | Behavioural | Control group, High-frequency telephone-based continuing care, Low-frequency telephone-based continuing care, SMS group |
Primary outcome
Number of days of alcohol abstinence
Time frame: Six months
1 secondary outcome
Number of days of alcohol abstinence
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Maria Soravia, Dr. phil. study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Dependence, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of alcohol abstinence (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.