Trial document




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  DRKS00011800

Trial Description

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Title

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

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Trial Acronym

StudiCare

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URL of the Trial

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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 physical and mental 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. . Distance-learning students are an especially diverse population in comparison to traditional university students as they are at high risk to experience multiple stressors (i.e. work-life-study-balance). Accordingly, a pilot online survey at the University in Hagen conducted between December 2016 and January 2017 has confirmed the need for and preference to mental health promotion services delivered via the Internet in distance-learning students. This target group can be best reached via online self-help interventions. 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 this study is to evaluate the efficacy of the web-based guided self-help program StudiCare in reducing psychological distress in distance-learning students compared to both an information-only control group. Participants receive feedback on demand from a trained online coach.

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Brief Summary in Scientific Language

Psychosocial 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 app-based and online self-help interventions are the method of choice for stressed distance-learning 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 distance-learning students. Within the framework of an prospective, randomized control study among distance students (N=200) experiencing a high levels of stress, the effects of the intervention group which gains access to the seven session intervention immediately will be compared to a a information-only control group 7 weeks and 3 months after completion of the intervention. Participants will train 7 weeks on a weekly basis. After the 3 month follow-up, the participants of the information-only control group also get 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 selfsupport and mindfulness. Participants will receive feedback on demand from an online coach and will be supported through mobile components in their daily life. Data is collected at the pre-intervention baseline, at 7 weeks and 3 months post-randomization. Symptoms of depression are measured as a primary outcome. Secondary outcomes include stresslevel, anxiety, self-compassion, maladaptive perfectionism, presenteeism and worrying or rumination.

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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

  •   DRKS00011800
  •   2017/02/27
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  •   yes
  •   Approved
  •   33_17 Bc, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   Z73 -  Problems related to life-management difficulty
  •   F32 -  Depressive episode
  •   stress
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Interventions/Observational Groups

  •   Intervention group: Online training with 7 sessions with 45-60 min. duration per session provided over the course of 7 weeks. The sessions are to be processed weekly by the participants. Upon request, the participants receive written confirmation by e-mail from an online coach. Four weeks after completion of the training, the participants receive a refresher course. Questionnaires are answered at pre-and post-term (7 weeks) as well as after 3 months.
  •   Information-only control group: The participants of this group receive weekly information on stress over 7 weeks. After a waiting period of 3 months, the participants receive access to the same training as participants of the intervention group. Questionnaires are answered at the pre-and post-date as well as the 3-month follow-up.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

depressive symptoms (allgemeine Depressionsskala, Hautzinger & Bailer1993):
pre, post (7 weeks), 3- month-Follow-Up

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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

- anxiety (short version of the Spielberger State-Trait Anxiety Inventory, Marteau & Bekker 1992): pre, post (7 weeks), 3- month-Follow-Up

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

- Concerns towards university life: (Academic worry questionnaire, Wolitzky &
Telch, 2005): 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

- client satisfaction (Client Satisfaction Questionnaire, Nguyen, Attkinson, & Stegner, 1983: post (7 weeks)

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/06/03
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Students enrolled at the University of Hagen; distict level of perceived study-related stress, ADS-Scale >=16, motivation to participate in an online intervention targeting stress reduction and willingness to complete 3 online survey (each with 45 min. duration), Internet access, willingness to provide a valid e-mail adress and telephon number to the study team

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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

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Addresses

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    • FernUniversität Hagen
    • Universitätsstr. 33
    • 58097  Hagen
    • Germany
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    • FernUniversität HagenLehrgebiet Gesundheitspsychologie
    • Ms.  Dr. rer. medic.  Jennifer  Apolinário-Hagen 
    • Universitätsstr. 33
    • 58097  Hagen
    • Germany
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    • FernUniversität Hagen
    • Ms.  Dr.  Jennifer  Apolinário-Hagen 
    • Universitätsstr. 33
    • 58097  Hagen
    • Germany
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Sources of Monetary or Material Support

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    • FernUniversität Hagen
    • Universitätsstr. 33
    • 58097  Hagen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/06
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* This entry means the parameter is not applicable or has not been set.