Bernburg 2020.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
|
Participants |
Baseline characteristics Psychosocial competence training combined with cognitive behavioural and solution‐focused counselling
Control (no intervention)
Overall
Included criteria: Inclusion criteria were: (1) regular access to the Internet, (2) full‐time employment in a clinic, (3) a maximum of two years of work experience (junior nurse), (4) availability and willingness to participate during the 36 weeks, (5) agree to complete the questionnaires, (6) no previous knowledge or experience with mental health promotion training. Excluded criteria: NR Pretreatment: Baseline data on socio‐demographic differences indicated only small, insignificant differences between intervention and control group (P > 0.05). Not recorded whether groups differed at baseline on the primary outcome perceived stress. Compliance rate: NR Response rate: difficult to assess as figure 1 is mentioned but not included in the article. Type of healthcare worker: exclusively junior nurses |
|
Interventions |
Intervention characteristics Psychosocial competence training combined with cognitive behavioural and solution‐focused counselling
Control (no intervention)
|
|
Outcomes |
Perceived Stress Questionnaire (PSQ)
Maslach Burnout Inventory ‐ Emotional Exhaustion
|
|
Identification |
Sponsorship source: NR Country: Germany Setting: Hospitals Comments: NA Authors name: Monika Bernburg Institution: Institute of Occupational Medicine, Social Medicine and Environmental Medicine, Goethe University, Germany Email: s.mache@uke.de Address: Address for correspondence: Stefanie Mache, Institute for Occupational Medicine and Maritime Medicine (ZfAM), University Medical Center Hamburg‐Eppendorf, Martinistraße 52, 20251Hamburg, Germany. Time period: NR |
|
Notes | MBI‐EE included in analysis 4.1 and 4.2 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "After answering the baseline questionnaire (t0) participants were randomized with the ratio 50%: 50% to the two study groups (IG or CG). The randomization process was accomplished with a computer generated list of numbers." |
Allocation concealment (selection bias) | Low risk | Quote: "This list was created by an independent research assistant; another assistant was blinded to the list, securing covered distribution to research conditions." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The CG group was asked to complete all surveys. The CG group received no intervention on mental health and did not undertake anything comparable to the intervention, e.g. any other training in psychosocial skills, counselling or therapy." Participants were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants were not blinded whereas outcomes are self‐reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Dropout attrition: There was an overall drop‐out rate (from randomization to analysis) of 12%. 10 participants decided to terminate the study (reasons included illness, non‐appearance of participants) and did not answer the questionnaires. Overall, four of the 94 participants at T1, 6/94 of participants at T2 and 4/94 of participants at T3 did not provide all follow‐up data on the results. The participants who did not provide all follow‐up data did not differ in any meaningful way, either in the primary outcome or in other baseline outcomes (P > 0.05), from those who provided data. " Low loss to follow‐up and follow‐up seems to be at random. |
Selective reporting (reporting bias) | Unclear risk | No trial registration or no study protocol reported, nor did we find one online |
Other bias | Unclear risk | Compliance rate not reported and response rate difficult to assess. Not recorded whether groups differed at baseline on the primary outcome perceived stress. |