Trial document




drksid header

  DRKS00010212

Trial Description

start of 1:1-Block title

Title

Online based self-help stress management program for students with feedback on demand

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

StudiCare

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.studicare.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Within the last few years, accumulated stress factors among students increased due to the restructuring of the study system of the Bologna process. These stress factors can be harmful for body and well-being. The amount of diagnosed mental illnesses and the subjective perception of stress accelerated as well. Therefore, there is an urgent need for appropriate measures for stress management that meet students' requirements.
StudiCare aims to reduce perceived stress and strain. It targets students who are seeking help in order to cope with personal and academic problems and to deal with difficult emotions. The aim of the study is to evaluate the efficacy of the one based, guided self-help concept compared to a waitlist control group. Participants receive feedback on demand from an online coach.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Stress at university is associated with a variety of mental and emotional problems, such as reduced work performance, exhaustion or anxiety. Self-help interventions offer an easier access to the student target group than face-to-face interventions. Especially online and internet based self-help interventions are the method of choice for stress students that tend to avoid formal therapeutical help. The aim of the study is to assess the efficacy and possible moderators and mediators of an internet-based stress management program for students. Within the framework of an prospective, randomized control study students (N=150) experiencing a high levels of stress will be randomly allocated into either the intervention group which gains access to the seven session intervention immediately or a waitlist control group which receives the intervention 3 months later. Participants will train on a weekly basis. After the 3 month follow-up, the participants of the waitlist control group also gets access to the intervention. The intervention is based on problem- and emotion-focused stress management according to Lazarus and contains systematic problem solving as well as effective emotion regulation strategies and practices concerning acceptance and tolerance, relaxation exercise, effective self-support and mindfulness. Participants will receive feedback on demand from an online coach and will be supported through mobile components in their daily life. Data are collected at baseline, at seven weeks and three months post randomization. Perceived stress is measured as a primary outcome. Secondary outcomes include symptoms of depression, anxiety, self-compassion, maladaptive perfectionism, presenteeism and worrying/rumination.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010212
  •   2016/05/12
  •   [---]*
  •   yes
  •   Approved
  •   322_15B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Z73 -  Problems related to life-management difficulty
  •   F32 -  Depressive episode
  •   Stress
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group: Online training consisting of 7 sessions within a time period of 7 weeks. Each session will be completed in approximately 45-60 minutes. Participants will train on a weekly basis. Participants receive feedback on demand via e-mail from an online coach. Four weeks after finishing the training, participants complete an additional booster session. Questionnaires are asked to be completed at pre- and posttest (7 weeks), as well as at 3 months follow up.
  •   Waitlist control group: Participants obtain access to the same training as participants of the intervention group after a waiting time of 3 months. Questionnaires are asked to be completed at pre- and posttest as well as at 3 months follow up.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Perceived Stress, measured with the Perceived Stress Scale (PSS-10, Cohen, Kamarck & Mermelstein, 1983) at Baseline, after the training (7 weeks) and at 3-months follow-up.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- suicide risk (Beck Depressions Inventar, Hautzinger, Keller & Kühner, 2006): pre

- Conscientiousness (Facets of Conscientiousness, MacCann, Duckworth, Roberts, 2008): pre

- credibility and expectancy of the training (credibility/expectancy questionnaire, Devilly & Borkovec, 2000): pre

- Willingness to pay (Willingness to pay questionnaire, Keith, Haddon, Birch, 2000): pre

- Anxiety (Kurzform des Spielberger State-Trait Anxiety Inventory, Marteau & Bekker 1992): pre, post (7 weeks), 3- month-Follow-Up

- depressive symptoms (allgemeine Depressionsskala, Hautzinger & Bailer 1993): pre, post (7 weeks), 3- month-Follow-Up

- subjective perceived stress and emotional exhaustion (Maslach Burnout Inventory für Studenten, Hamborg, Schoppe, Braun & Straatmann, 2012): pre, post (7 weeks), 3- month-Follow-Up

- subjective perceived quality of life (WHO 5- Wohlbefindens-Index, Brähler, Mühlan, Albani & Schmidt, 1998): pre, post (7 weeks), 3- month-Follow-Up

- Concerns towards university life: (Academic worry questionnaire, Wolitzky & Telch, 2005): pre, post (7 weeks), 3- month-Follow-Up

- Perfectionism (Almost Perfect Scale Revised, Slaney, Rice, Mobley, Trippi, Ashby, 2001): pre, post (7 weeks), 3- month-Follow-Up

- reduced ability to work due to health problems (Presenteeism Scale for Students, Matsushita et al., 2011): pre, post (7 weeks), 3- month-Follow-Up

- risk and protective factors (Rosenberg Self-Esteem Scale, Ferring & Filipp, 2003): pre, post (7 weeks), 3- month-Follow-Up

- risk and protective factors (Connor & Davidson resilience scale, Connor & Davidson, 2003): pre, post (7 weeks), 3- month-Follow-Up

- academic self-efficacy (College Self-Efficacy Inventory, Solberg, O’Brien, Villareal, Kennel & Davis, 1993): pre, post (7 weeks), 3- month-Follow-Up

- emotionregulation competence (Fragebogens zur Selbsteinschätzung Emotionaler Kompetenzen, Berking & Znoj, 2008): pre, post (7 weeks), 3- month-Follow-Up

- Amount of self-compassion (Self- Compassion Scale, Hupfeld & Ruffieux, 2011): pre, post (7 weeks), 3- month-Follow-Up

- internal/external locus of control (Multidimensional Locus of Control Scale Form C, Wallston, Stein, Smith, 1994): pre, post (7 weeks), 3- month-Follow-Up

- Repetitive negative thoughts (Behavioral Activation for Depression Scale, Fuhr et al, noch unveröffentlicht):pre, post (7 weeks), 3- month-Follow-Up

- Psychological flexibility (Acceptance and Action Questionnaire II, Lloyd et al. 2013): pre, post (7 weeks), 3- month-Follow-Up

- problem solving (Diagnostisches Inventar Problemlösen, Dirksmeier, 1991): pre, post (7 weeks), 3- month-Follow-Up

- satisfaction with the intervention (Client Satisfaction Questionnaire, Nguyen, Attkinson, & Stegner, 1983: post

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/05/09
  •   150
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Enrollment at a university or higher education institution, distinct level of perceived university related stress, internet access, valid e-mail address

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

At Baseline slightly suicidal (BDI II item 9 >1), not willing to sign informed consent, diagnosed psychosis or dissociative symptoms in the past

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Friedrich-Alexander Universität Erlangen-Nürnberg, Lehrstuhl für Klinische Psychologie und Psychotherapie
    • Mr.  Dr.  David Daniel  Ebert (Ansprechpartner des Sponsors) 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Friedrich-Alexander Universität Erlangen-Nürnberg, Lehrstuhl für Klinische Psychologie und Psychotherapie
    • Mr.  Dr.  David Daniel  Ebert (Ansprechpartner des Sponsors) 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Friedrich-Alexander Univerität Erlangen Nürnberg
    • Mr.  Mathias  Harrer 
    • Nägelsbachstraße 25 a
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Lehrstuhl für klinische Psychologie und Psychotherapie (Klips), Institut für Psychologie
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   09131-85 67575
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/01/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.