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Telephone-Based Continuing Care for Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT02030093
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Bern

Tracking Information
First Submitted Date December 19, 2013
First Posted Date January 8, 2014
Last Update Posted Date October 6, 2017
Actual Study Start Date December 9, 2013
Actual Primary Completion Date June 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2014)
Number of days of alcohol abstinence [ Time Frame: Six months ]
Original Primary Outcome Measures
 (submitted: January 6, 2014)
Number of abstinent days after completion of treatment program [ Time Frame: Six months ]
Change History
Current Secondary Outcome Measures
 (submitted: January 21, 2014)
Number of days of alcohol abstinence [ Time Frame: One year ]
Original Secondary Outcome Measures
 (submitted: January 6, 2014)
  • Change from baseline of the heart rate variability [ Time Frame: 12 weeks ]
    Measured by total power, high frequency power, low frequency power, low-to-high frequency power ratio
  • Change from baseline in craving [ Time Frame: 12 weeks ]
    Measured by analogue scale and the german version of the alcohol craving questionnaire (ACQ-R; Raabe, Grusser, Wessa, Podschuss & Flor, 2005)
  • Change from baseline in emotion regulation [ Time Frame: 12 weeks ]
    Measured by the Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27; Berking & Znoj, 2008)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Telephone-Based Continuing Care for Alcohol Dependence
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
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients of the clinic Südhang (Bern) and the Forel clinic (Zürich), both specialized clinics for the treatment of alcohol dependency
Condition Alcohol Dependence
Intervention Behavioral: Telephone-based counseling
Telephone-based continuing care wil be provided to patients in different frequency
Study Groups/Cohorts
  • High-frequency telephone-based continuing care
    High-frequency telephone-based continuing care
    Intervention: Behavioral: Telephone-based counseling
  • Low-frequency telephone-based continuing care
    Low-frequency telephone-based continuing care
    Intervention: Behavioral: Telephone-based counseling
  • SMS group
    SMS group
    Intervention: Behavioral: Telephone-based counseling
  • Control group
    Control group
    Intervention: Behavioral: Telephone-based counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2016)
317
Original Estimated Enrollment
 (submitted: January 6, 2014)
40
Actual Study Completion Date January 12, 2017
Actual Primary Completion Date June 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02030093
Other Study ID Numbers 077/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Bern
Study Sponsor University of Bern
Collaborators Not Provided
Investigators
Study Chair: Leila Maria Soravia, Dr. phil. University of Bern
PRS Account University of Bern
Verification Date October 2017