Trial document




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  DRKS00007860

Trial Description

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Title

Reduction of harmful alcohol and tobacco use in the general population by individualized e-coach assisted computer or smartphone interventions. Study part 1

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Trial Acronym

CS-I

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Recently e-based interventions become more common and promising for different indications. The main advantages compared to conventional guidance are the time- and location-independent utilisation and individualised adaptation of treatment. This study is funded by the Federal Ministry of Education and Research. Its major aims are the development of easily accessible internet- and smartphone-based interventions/ programs addressing smoking persons with hazardous alcohol consumption (but without alcohol addiction). Secondly the practicability and user associated acceptance are evaluated. In this first feasibility trial 40 persons will test the new developed, online 12-week program „Gesünder leben – Tabak & Alkohol“. Participants will be asked about their alcohol and tobacco consumption behaviour during and after the end of intervention and content feedback group analysis will be used for revision of the program.

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Brief Summary in Scientific Language

Consumption of alcohol and tobacco are the most significant and avoidable health hazards. Due to low acceptance of face-to-face interventions, e-based interventions that include internet or mobile phone facilities to decrease alcohol or tobacco consumption are considered to be an alternative promising strategy. Although first data show internet-based therapies for addictions to be effective in achieving behavioural changes a lot more research is necessary to determine comparative effectiveness, role of setting and moderator variables as well as appropriate target groups and setting conditions.
To test the efficacy of web-based interventions to decrease alcohol and tobacco consumption we address non-student individuals. Because of the lack of experience regarding content and plausible efficacy of an intervention in this subgroup we will start with a proof-of-concept-study to provide data on feasibility, acceptance, self-efficacy and readiness to change and related variables by developing a web based and smartphone application ("platform") for harmful alcohol and tobacco consumption in patients with co-occurring hazardous alcohol consumption and regular smoking. The intervention will be designed as an intervention tailored to the subjects’ risk- and consumption-profile.
It is assumed that individuals benefit from an intervention that is designed to increase the perceived self-efficacy and the level of motivation to change in context with substance use. This can be achieved by providing easily accessible strategies for change of behaviour using online and smartphone applications. As a result a reduction in smoking and alcohol consumption or change of consumption patterns are expected.
The main goals and research questions for this study focus on: (1) Establishment of practical patterns to identify patients with hazardous alcohol- and tobacco use in two different recruitment settings (primary health care and hospital), (2) development of easily accessible internet- and smartphone-based applications addressing smoking persons with hazardous alcohol consumption and (3) achievement of data and evaluation of utilization and practicability from N=40 users.
Finally, content focus group analysis (N=30 participants) will be used for revision of the program.

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Organizational Data

  •   DRKS00007860
  •   2015/12/09
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  •   yes
  •   Approved
  •   304/2015BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
  •   F17.1 -  Mental and behavioural disorders due to use of tobacco; Harmful use
  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
  •   hazardous alcohol consumption (women >12 g/d, men > 24g/d)
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Interventions/Observational Groups

  •   Experimental intervention: internet-based / smartphone adapted individualised application for a 12 week brief intervention program including 12 chapters using motivational interviewing techniques to quit or reduce alcohol or tobacco consumption (CS-I). Weekly duration varies according to the intensity of use. The intervention will be designed as an intervention tailored to the subjects’ risk- and consumption-profile. Analysis of usability and practicability using a qualitative research design (focus groups, 5 interview groups, 5-8 subjects each).
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Utilization and practicability of the developed online/smartphone application by computer-aided qualitative content analysis of research data gained from focus groups (N=30 subjects, 5 interview groups, 5-8 subjects each) 4 weeks after completing treatment of N=40 subjects receiving the newly developed experimental intervention CS-I (no control group).

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Secondary Outcome

Alcohol and tocbabbcco use (amount and frequency; Timeline Followback) and motivation to change (Prochaska und DiClemente; Likert-Scale) weekly during receiving the newly developed online-intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/01/15
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   64   Years
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Additional Inclusion Criteria

harmful alcohol consumption (> 12g alcohol/day in women; > 24 g alcohol/day in men or at least one binge-drinking-day/month defined as at least 4 drinks/day in women and at least 5 drinks/day in men);
smoking at least 5 cigarettes per day for the last 4 weeks, smoking duration at least 2 years;
sufficient language capability;
access to the internet at least once per week (PC or smartphone)

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Exclusion Criteria

Moderate/Severe Alcohol Use Disorder (DSM 5);
Severe cognitive impairment (clinician's assessment; ICD-10 F0x, F72);
Severe organic disease which enables eligibility (clinician's assessment, e.g. moribund patient);
bipolar disorder or schizophrenia (self report, ICD 10 F2x, F31);
consumption of illicit drugs during the last 5 years (ICD 10 F10, F11-F16, F18, F19);
Treatment utilisation because of alcohol or tobacco use during the last 4 weeks prior to enrolment in the study.

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie Universität Lübeck
    • Mr.  PD Dr.  Hans-Jürgen  Rumpf 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Sozialmedizin und Prävention
    • Mr.  Prof. Dr. phil  Ulrich  John 
    • Walther-Rathenau-Straße 48
    • 17475  Greifswald
    • Germany
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    • University Hospital pf Psychaitry and Psychotherapie
    • Mr.  Prof. Dr. med.  Anil  Batra 
    • Calwerstraße 14
    • 72076  Tuebingen
    • Germany
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    • University Hospital pf Psychaitry and Psychotherapie
    • Mr.  Prof. Dr. med.  Anil  Batra 
    • Calwerstraße 14
    • 72076  Tuebingen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/06
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.