Trial document




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  DRKS00011635

Trial Description

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Title

Individually tailored E-health interventions for primary care patients with problematic alcohol use and co-occurring depressive symptoms: Phase IIa - proof of concept study

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Trial Acronym

ITE (Phase 2)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Depressive symptoms frequently co-occur and may interact with alcohol use. Computer-based
interventions provide an alternative to physician delivered advice and may allow the treatment of
both conditions with reduced demands in terms of time and costs. Expert-systems interventions
can provide individualized feedback to users via different communication channels including print
material, Internet or SMS. In the present project unselected patients from the general hospital and
general medical practices will be systematically screened for co-occurring at risk alcohol
consumption and depressive symptoms. The intervention will be developed within the project and
continuously optimized based on patients feedback. In the second study phase which is described
here a randomised controlled trial with 120 patients will be conducted to test the feasibility of the study design and to detect initial signs of intervention efficacy.

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Brief Summary in Scientific Language

Data reveals that systematic screening and brief behavioral counseling for hazardous alcohol
consumption are feasible for use in entire populations of primary medical care patients. It has the
potential to substantially improve public health. However, co-occurring mental disorders that are
prevalent have not been considered sufficiently in such an approach. Depressive symptoms
frequently co-occur and may interact with alcohol use. Evidence from psychotherapy research
revealed that combined treatment of both conditions is superior to single focused interventions.
Recent evidence shows that computer-based interventions promise to provide highly
individualized counseling and serve as a cost- and timesaving alternative to physician-delivered
counseling. By comparing patient data with a norm database and with individual data assessed
across time, expert-system technology allows for tailoring information to relevant psychological
states. Interactions with the intervention system include contacts via print mail, e-mail, Internet
and SMS. The rationale of the present study is to increase effectiveness of available
computerbased interventions targeting patients with hazardous alcohol use and with depressive
symptoms. No such intervention has been developed so far for unselected populations. The study
encompasses the development of intervention and subsequent refinements based on on the feedback
of patients who will be recruited in the primary medical care settings. One main advantage is
that patients who do not intend to change drinking behavior are included.The objectives of the
study are: (1) To develop a combined e-healthintervention targeting alcohol use and depressive symptoms in entire populations of primary care
patients (study phase 1); (2) To improve the acceptability and usability of the intervention based on qualitative data
and process measures patients (study phase 1) (3) To develop and test effective research procedures and finalize SOPs for
a subsequent large scale clinical trial, including multi-site
patient recruitment, centralized provision of interventions and IT-structures providing data
protection and security (study phase 2); (4) Explore signs of intervention efficacy.

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Organizational Data

  •   DRKS00011635
  •   2017/01/20
  •   [---]*
  •   yes
  •   Approved
  •   BB 161/16, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

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Health Condition or Problem studied

  •   At-risk alcohol consumption (average daily intake of alcohol > 12g for women / >24g
    men or >= one occasion a month with >= 4 alcoholic drinks for women / >= 5 drinks for men).
    At-risk alcohol consumption is considered as a risk factor for Harmful Alcohol use (ICD-10
    F10.1), Alcohol Dependence Syndrome (ICD-10 F10.2), and other alcohol attributable disease.
  •   subsyndromal depressive symptoms, major
    depression (ICD-10 F32) or dysthymia (ICD-10 F34.1)
  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
  •   F32 -  Depressive episode
  •   F34.1 -  Dysthymia
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Interventions/Observational Groups

  •   Participants will receive computer-based individually tailored personalized motivational
    feedback across different communication channels (e.g. print, e-mail, SMS, Internet) over a
    period of six months. The feedback is generated by fully standardized and automated
    computer software using expert-system technology. The intervention techniques were
    adapted from available brief interventions separately developed for the treatment of addictive and depressive disorders. The intervention system includes multiple interactions
    with the patients. Recurrent assessments are initiated by the system and provided data for
    scheduling the proceeding intervention steps, and selection of relevant content. Alcohol use
    and motivational measures to change consumption and depressive symptoms will be
    monitored across time and used to provide ipsative feedback for patients.
  •   Assessment only control group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   IIa
  •   N/A
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Primary Outcome

A sensitive surrogate marker related to drinking behavior
change will be analyzed to test potential intervention efficacy.
The marker will be a latent composite measure including 1)
Frequency of heavy alcohol drinking days, 2) average alcohol intake on drinking days, 3) frequency of drinking days, 4)
Intention to change drinking behavior

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Secondary Outcome

1) Occurrence of depressive episodes,
2) Severity of depressiveness in the worst episode,
3) depressiveness at time of follow-up assessment,
4) frequency of use of depression preventive strategies

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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

  •   Planned
  •   2017/01/22
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1) At-risk alcohol consumption (average daily alcohol use of >12g women / 24g men or >= one
occasion a month with >= 4 alcoholic drinks for women / >= 5 drinks for men)
2) subsyndromal depressive symptoms, major depression or dysthymia in the past 12 months.

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Exclusion Criteria

1. Severe episode of major depression within the past 12 month and depressive symptoms in the
past 2 weeks;
2. Moderate/severe alcohol use disorder according to DSM-5;
3. Illiteracy, cognitive impairment;
4. Acute or severe illness, which did not allow participation in the study;
5. less than weekly use of the Internet and no accessibility by cell phone.

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Addresses

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    • Universitätsmedizin Greifswald, Institut für Sozialmedizin und Prävention
    • Walther-Rathenau-Str. 48
    • D-17489  Greifswald
    • Germany
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    • Universitätsmedizin GreifswaldInstitut für Sozialmedizin und Prävention
    • Mr.  Prof. Dr.  Christian  Meyer 
    • Walter-Rathenau-Straße 48
    • 17475  Greifswald
    • Germany
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    • Universitätsmedizin GreifswaldInstitut für Sozialmedizin und Prävention
    • Mr.  Prof. Dr.  Christian  Meyer 
    • Walter-Rathenau-Straße 48
    • 17475  Greifswald
    • 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 planned
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Trial Publications, Results and other Documents

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