Comparative efficacy and cost-effectiveness of Internet-based Stressmanagment with and without guidance.
Organizational Data
- DRKS-ID:
- DRKS00005687
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2014-06-06
- Last update in DRKS:
- 2014-06-06
- Registration type:
- Prospective
Acronym/abbreviation of the study
GET.ON Stress Role of Support?
URL of the study
https://geton-training.de/stressbewaeltigung.php
Brief summary in lay language
Occupational stress constitutes a risk factor for a variety of psychological and physical disorders. In general, stress is associated with unfavourable health behaviours and leads to loss of productivity at work and affects private life. The "Flexible Internet Training for managing work-related stress" aims to reduce perceived stress and depressive symptoms. It targets employees who are seeking help for coping with personal problems and dealing with difficult emotions. The aim of the study is to evaluate the efficacy of the online training, which can support participants in recognizing their personal stressors, choosing effective coping strategies and strengthening their abilities to solve personal and work-related problems in a systematic and effective manner. Furthermore, it aims to improve their way of dealing with stress and difficult emotions in occupational and private life. This study will compare three study arms: pure self-help, guided self-help, and a 6-month waiting list control group.
Brief summary in scientific language
Work-related stress is associated with a variety of mental and emotional problems, such as symptoms of depressions, anxiety, and sleep disturbances. This can lead to substantial economic costs due to loss of productivity, absenteeism or inability to work. There is a considerable amount of evidence on traditional face-to-face stress management interventions; however, they are costly, time-consuming and only available for a certain number of people. The aim of the study is to assess the comparative efficacy and cost-effectiveness of an internet-based self-help stress managment program and a guided self-help version of the same program. N=396 employees experiencing high levels of stress (Perceived Stress Scale ≥ 22) will be randomly allocated into one of three groups: pure self-help, guided self-help or a 6-month waiting list control group. The intervention is based on problem- and emotion-focused stress management according to Lazarus and contains systematic problem solving as well as effective strategies for emotion regulation. Data is collected in a baseline survey, seven weeks and six months after randomization. Primary Outcome is perceived stress.
Health condition or problem studied
- Free text:
- work-related stress
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- intervention group A: Online Training consisting of 7 sessions. Each session will be completed in approximately 45-60 minutes. Four weeks after finishing the training, participants complete an additional booster session. Questionnaires are completed at pre- and posttest (7 weeks), as well as at 6 months follow up.
- Arm 2:
- intervention group B: Online Training consisting of 7 sessions. Each session will be completed in approximately 45-60 minutes. 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 completed at pre- and posttest (7 weeks), as well as at 6 months follow up.
- Arm 3:
- waitlist control group: After 6 months, participants obtain access to the same training as participants of the intervention group A. Questionnaires are completed at pre- and posttest as well as 6 months follow up.
Endpoints
- Primary outcome:
- Perceived Stress, measured with the Perceived Stress Scale (PSS-10; Cohen, 1983) at Baseline, after the training (7 weeks) and at 6-months follow-up (6-M-FU).
- Secondary outcome:
- • Emotional exhaustion (Maslach Burnout Inventory, MBI-GS-D, emotional exhaustion scale, Maslach & Jackson, 1981): pre, post (7 weeks), 6-M-FU • Depressive symptoms (CES-D, Hautzinger & Bailer, 1993): pre, post, 6-M-FU • Self-assessed emotional competences (SEK-27, Berking & Znoj, 2008): pre • Dimensions of personality (Big Five Inventory, BFI-10, Rammstedt & John, 2007): pre • Volitional competences (Short Form of the Volitional Components Questionnaire, SSI-36, Forstmeier & Rüddel, 2008; subscales of attentional focusing, self-motivation, goal recollection, forgetfulness prevention, impulse control and initiation control): pre • Self-efficacy (SWE, Schwarzer & Jerusalem, 1999): pre • Self-Regulation Scale (SRQ, Schwarzer, 1999): pre • Self-Control Scale (SCS-K-D. Bertrams & Dickhäuser, 2009): pre • Therapy motivation questionnaire (FPTM-23, Schulz, Lang, Nübling, & Koch, 2003): pre • Task-related motivational and volitional factors in line with the Health Action Process Approach (HAPA, according to guidelines by Schwarzer et al., 2003): pre • Effort-Reward Imbalance, short version (ERI-S, Siegrist, Wege, Pühlhofer, & Wahrendorf, 2009): pre, post, 6-M-FU • Work engagement (Utrecht Work Engagement Scale, UWES, Schaufeli, Salanova, González-Romá, & Bakker, 2002): pre, post, 6-M-FU • Quality of life and subjective functioning (Short form health survey, SF-12, Morfeld, Kirchberger, Bullinger): pre, post, 6-M-FU • Quality of life for economic evaluation (EuroQol, Graf, Claes, Greiner, & Uber): pre, post, 6-M-FU • Current occupation (self-development): pre • Cost related to mental and physical impairment (German adaption of Trimbos / iMTA questionnaire for Costs associated with Psychiatric Illness, TiC-P, Van Roijen Hakkaart, 2002): pre, post, 6-M-FU • Dropout reasons (self-development): post • Training satisfaction: self-development based on participants´satisfaction questionnaire (ZUF 8, Schmidt, Lamprecht, Wittmann, 1989) and the Client Satisfaction Questionnaire (CSQ, Attkisson & Zwick, 1982): post • Work Limitations Questionnaire (WLQ-8, Lerner, Amick, Rogers, Malspeis, Bungay, & Cynn, 2001), measuring the on-the-job impact of chronic health problems (pre) • Connor-Davidson Resilience Scale (CD-RISK, Campbell-Sills & Stein, 2007), measuring the abil- ity to cope with adversity (pre) • Internet Affinity Scale (Papacharissi & Rubin, 2000), measuring internet affinity (pre)
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Leuphana Universität Lüneburg (Teilnehmer werden über die Forschungswebsite www.geton-training.de rekrutiert/participants are recruited via the research website www.geton-training.de)
Recruitment period and number of participants
- Planned study start date:
- 2014-09-24
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 408
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- distinct level of perceived stress (Perceived Stress Scale [PSS-10] ≥ 22), access to the internet, valid e-mail-adress, employed
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
Addresses
Primary Sponsor
- Address:
- Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-InkubatorDr. David Daniel Ebert (Ansprechpartner des Sponsors)Rotenbleicher Weg 6721335 LüneburgGermany
- Telephone:
- 017616781057
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.leuphana.de/inkubator
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-InkubatorDavid EbertRotenbleicher Weg 6721335 LüneburgGermany
- Telephone:
- 041316777654
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.leuphana.de/inkubator/gesundheit/geton.html
Contact for Public Queries
- Address:
- Inkubator KT-GET.ONLeuphana Universität LüneburgDipl. Sozialpäd. Torsten TarnowskiScharnhorststr. 121335 LüneburgGermany
- Telephone:
- 04131-677-7651
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.geton-training.de
Principal Investigator
- Address:
- Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-InkubatorDavid EbertRotenbleicher Weg 6721335 LüneburgGermany
- Telephone:
- 041316777654
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.leuphana.de/inkubator/gesundheit/geton.html
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Investitions-und Förderungsbank Niedersachsen (NBank)Günther-Wagner-Allee 12-1630177 HannoverGermany
- Telephone:
- 0511 300310
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.nbank.de
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Barmer GEKLichtscheider Str. 8942285 WuppertalGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.barmer-gek.de
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und VerkehrFriedrichwall 130159 HannoverGermany
- Telephone:
- 0511300310
- Fax:
- /
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.nbank.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission des Fachbereichs Psychologie der Philipps-Universität Marburg [Marburg - Ethik-Kommission des Fachbereichs Psychologie der Philipps-Universität Marburg]Gutenbergstr. 1835037 MarburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-marburg.de/fb20/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-01-26
- Ethics committee number:
- Aktenzeichen 2014-05k
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-06-04
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Ebert et al. (2014) Study Protocol
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry