AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Switzerland

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.

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 groups in NCT02030093
Study groupRoleWhat they receive
High-frequency telephone-based continuing careHigh-frequency telephone-based continuing care
Receives: Behavioral: Telephone-based counseling
Low-frequency telephone-based continuing careLow-frequency telephone-based continuing care
Receives: Behavioral: Telephone-based counseling
SMS groupSMS group
Receives: Behavioral: Telephone-based counseling
Control groupControl group
Receives: Behavioral: Telephone-based counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days of alcohol abstinence

    Measured: Six months

Secondary outcomes (1)
  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.

  1. First posted8 Jan 2014 (estimated)
  2. Study start9 Dec 2013
  3. Primary completion27 Jun 2016
  4. Study completion12 Jan 2017

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in