Trial document




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  DRKS00015236

Trial Description

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Title

SaveMySkin: A Pilot Study about an Internet- and Smartphone-based Self-Help Intervention for Skin Picking.

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Trial Acronym

SaveMySkin

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URL of the Trial

https://www.savemyskin.de

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Brief Summary in Lay Language

Since 2013, Excoriation (Skin Picking) Disorder is officially recognized as a discrete diagnosis for which comparatively high prevalence rates are reported. Associated medical risks and severe psychosocial impairment underline the necessity of specialized support and treatment options.
Aim of the present study is the first evaluation of a support program for affected people in the German-speaking area. The program SaveMySkin consists of several modules, which provide information and practical strategies as well as support in finding appropriate treatment options.
The pilot study will investigate attitudes and expectations towards the intervention, acceptance, adherence, user behavior, user satisfaction and the willingness to participate. In addition, the feasibility of study procedures and processes will be analyzed in preparation of a subsequent efficacy study.
For this purpose, 100 participants will be recruited and randomized to one of the study groups (intervention- or controlgroup). We assume that participation in the intervention will be associated with a positive effect on reported symptoms and psychological impairment. Furthermore, we pursue an increased utilization of existing treatment options within primary healthcare.

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Brief Summary in Scientific Language

Since 2013, Excoriation (Skin Picking) Disorder is officially recognized as a discrete diagnosis within the fifth edition of the DSM. Comparatively high prevalence rates are reported for this diagnosis, and associated medical risks and severe psychosocial impairment underline the necessity of specialized support and treatment options.
Aim of the present study is the first evaluation of a support program for affected people in the German-speaking area. SaveMySkin is intended to function as a first contact point, which provides information and practical strategies and offers support in finding appropriate treatment options. The program consists of several modules based on cognitive behavior therapy and can be used for a duration of three month after registration.
The study will be conducted within a 2-arm randomized waiting list control design. The planned sample size includes 100 participants, who can register themselves after a short online screening questionnaire. Study assessments via online self-report measures take place at baseline, six weeks later and three month after randomization.
The pilot study will investigate attitudes and expectations towards the intervention, acceptance, adherence, user behavior, user satisfaction and the willingness to participate. In preparation of a subsequent efficacy study, the feasibility of study procedures and processes will be analyzed and effects on symptoms and impairment will be estimated.
We assume that participation in the intervention will be associated with a positive effect on reported symptoms and psychological impairment. Furthermore, we pursue an increased utilization of existing treatment options within primary healthcare.

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Organizational Data

  •   DRKS00015236
  •   2018/08/13
  •   [---]*
  •   yes
  •   Approved
  •   S-600/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   DSM-5 Excoriation (Skin Picking) Disorder
  •   F63.9 -  Habit and impulse disorder, unspecified
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Interventions/Observational Groups

  •   Intervention group participants can use the online self-help intervention „SaveMySkin“ for three month.
    Study assessments via online self-report measures take place at baseline, six weeks later and three month after randomization.
  •   Study assessments via online self-report measures also take place at baseline, six weeks later and three month after randomization in the control group. After the final assessment, participants in the control group can also use the program for three month.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

a) Attitudes, expectations and user satisfaction: Attitudes and expectations towards information and communication (ICT) based intervention programs at baseline and user satisfaction after participation

b) Adherence: Extent to which the intervention group uses the program (assessed via automatic documentation in the data bank of the program) and dropout-rate

c) Willingness to participate

d) Rough estimation of intervention effects: Skin picking severity is assessed with the German version of the Skin Picking Scale-Revised (Gallinat, Keuthen, & Backenstrass, 2016).

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Secondary Outcome

a) Eligibility of applied questionnaires: Distribution parameter for the evaluation of potential ceiling and floor effects

b) Feasibility of organizational processes: recruitment, randomization

c) Rough estimation of intervention effects on secondary outcomes: General mental impairment is assessed with the Clinical Psychological Diagnosis System 38 (Percevic et al., 2005). Additionally, the German version of the Skin Picking Impact Scale (SPIS; Mehrmann, Hunger, & Gerlach, 2017) is applied to measure skin picking related psychosocial impairment.
The dimensions of skin picking (focused vs. automatic) are evaluated with the German translation of the Milawaukee Inventory for the Dimensions of Adult Skin Picking (MIDAS; Walther, Fleyyner, Conelea, & Woods, 2009).
Emotion regulation strategies are assessed by the Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah, Barnow, Neubaer, & Holl, 2017)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/10/02
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   17   Years
  •   no maximum age
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Additional Inclusion Criteria

-SPS-R Score ≥ 7
-Age ≥ 17 years
-sufficient German language skills
-Smartphone
-Internetaccess

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Heidelberg Forschungsstelle für Psychotherapie
    • Bergheimer Str. 54
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergHautklinik
    • Mr.  Prof. Dr. med.  Holger  Hänßle 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Forschungsstelle für Psychotherapie
    • Ms.  MSc.  Christina  Gallinat 
    • Bergheimer Str. 54
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Forschungsstelle für Psychotherapie
    • Ms.  MSc.  Christina  Gallinat 
    • Bergheimer Str. 54
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg Forschungsstelle für Psychotherapie
    • Bergheimer Str. 54
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/03/01
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* This entry means the parameter is not applicable or has not been set.