Comparative efficacy and cost-effectiveness of Internet-based Stressmanagment with and without guidance.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00005687
• Date of registration: 06/06/2014
• Prospective Registration: Yes
• Primary sponsor: Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
• Public title: Comparative efficacy and cost-effectiveness of Internet-based Stressmanagment with and without guidance.
• Scientific title: Comparative efficacy and cost-effectiveness of Internet-based Stressmanagment with and without guidance. - GET.ON Stress Role of Support?
• Date of first enrolment: 24/09/2014
• Target sample size: 408
• Recruitment status: Pending
• URL: http://drks.de/search/en/trial/DRKS00005687
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//No treatment / Standard of care; Assignment: parallel; Study design purpose: prevention
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Torsten Tarnowski
• Affiliation: Inkubator KT-GET.ONLeuphana Universität Lüneburg

• Name: David Ebert
• Affiliation: Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

work-related stress

Intervention(s)

Group 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.
Group 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.
Group 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.

Primary Outcome(s)

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(s)

• 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)

Source(s) of Monetary Support

Barmer GEK

Investitions-und Förderungsbank Niedersachsen (NBank)

European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr

Ethics review

Status: Approved
Approval date: 04/06/2014
Contact:

Ethik-Kommission des Fachbereichs Psychologie der Philipps-Universität Marburg [Marburg - Ethik-Kommission des Fachbereichs Psychologie der Philipps-Universität Marburg]

Results

• URL: http://drks.de/search/en/trial/DRKS00005687#studyResults