Trial document




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  DRKS00016860

Trial Description

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Title

Effectiveness of a self-help approach (Imaginal Retraining) to reduce cigarette consumption

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Trial Acronym

Imaginal Retraining

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URL of the Trial

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Brief Summary in Lay Language

The aim of the present study is to investigate the acceptance and effectiveness of a self-help approach to reduce cigarette consumption in a sample of smokers. We expect that the treatment group will show a greater reduction in the amount of daily smoked cigarettes compared to a waiting control group. At total of 100 people wishing to quit smoking are randomly assigned to two groups (treatment group or waitlist control group). In order to measure a change in symptoms, various self-assessment questionnaires are administered at two points in time every four weeks.

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Brief Summary in Scientific Language

Consumption of cigarettes is accompanied by serious health problems and thus leads to high economic costs. Many of those affected do not seek help or only very late when subsequent health problems have already occurred. The aim of the present study is to investigate the acceptance and effectiveness of a self-help therapy program against tobacco smoking in a sample of participants wishing to quit smoking. The treatment manual is based on the so-called Retraining approach, which is tested in an in imaginal version. We suspect that the intervention group shows a greater reduction in the amount of daily smoked cigarettes and urge to smoke compared to a waiting control group. A total of 100 persons with self-reported tobacco consumption are randomly assigned to either the intervention group or to a waitlist control group. After 6 weeks all participants will be invited for a reassessment. The primary outcome is a question item assessing the amount of daily smoked cigarettes taken from the Cigarette Dependence Scale (CDS).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016860
  •   2019/03/07
  •   [---]*
  •   yes
  •   Approved
  •   LPEK-0023, Lokale Psychologische Ethikkommission des UKE
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Secondary IDs

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Health Condition or Problem studied

  •   F17 -  Mental and behavioural disorders due to use of tobacco
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Interventions/Observational Groups

  •   Interventional = anonymous online pre assessment; 6-week Self-help Intervention (imaginal retraining), which is sent as a PDF file by E-Mail; anonymous online post-assessment after 6 weeks
  •   Wait-list control group = does not receive any additional treatment in the intervention time period (but may continue previously initiated treatment); gets access to treatment manual after completion of the post survey
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Visual Analogue Scale (VAS) measuring craving: Visual Analogue Scale assessing the smoking demand over the last week [in accordance with pilot trial DRKS00015319]

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Secondary Outcome

- Beck Depression Inventory II (BDI-II): Self-rating questionnaire measuring depressive symptoms in the last 2 weeks (at baseline- and post-assessment)
- Patient Health Questionnaire-9 (PHQ-9): Self-rating questionnaire measuring depressive symptoms over the past week (at baseline- and post-assessment).
- Fagerström Test for Nicotine Dependency (FTND): Self-rating questionnaire measuring the severity of addiction (at baseline- and post-assessment).
- Cigarette Dependence Scale (CDS): Self-rating-questionnaire assessing nicotine dependency according to DSM-IV and ICD-10 criteria
- Questions regarding the smoking-history: Among other things assessing the amount of years the participant has been smoking and the number of attempts to quit smoking
- Quality of life (WHO-QOL-BREF): Global value of the self-assessment questionnaire, which measures the quality of life in the last two weeks (at baseline- and post-assessment).
- Generalized Anxiety Disorder 7 (GAD-7): Self-rating questionnaire to measure the general anxiety level over the last two weeks (at baseline- and post-assessment).
- University of Rhode Island Change Assessment Scale (URICA): Self-report questionnaire that assesses moderators of change (at baseline assessment).
- Credibility/Expectancy Questionnaire (CEQ): One item that measures treatment expectations (at baseline assessment).
- Questionnaire on patient satisfaction in modified version (ZUF-8): Self-report questionnaire that measures the global patient satisfaction at the end of treatment (at post-assessment).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/03/11
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- consent to participate in study (informed consent)
- internet access
- sufficient command of the German language
- willingness to participate in two anonymous online surveys, each of which lasts approx. 25-30 minutes
- willingness to participate in a 6-week training program
- willingness to use the program on one's own responsibility
- willingness to provide an e-mail address

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Exclusion Criteria

- lifetime schizophrenia
- acute suicidal tendencies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Hamburg-EppendorfKlinik und Poliklinik für Psychiatrie und PsychotherapieArbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   +49 40 7410 56565
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    •   moritz at uke.de
    •   [---]*
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Arbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Arbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Hamburg-EppendorfKlinik und Poliklinik für Psychiatrie und PsychotherapieArbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/22
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Trial Publications, Results and other Documents

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