Recovery, PsychologicalNCT06678347
Leadership for Recovery: Evaluation of an Intervention Programme for First-line Healthcare Managers
A study testing Leadership for recovery in people with Recovery, Psychological and Sleep, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The goal of this intervention study is to evaluate a group intervention programme that aims to support first-line healthcare managers in promoting their employees' recovery through a "leadership for recovery". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recovery, Psychological, Sleep, Burnout
- What is being tested?
- Leadership for recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 2 sitesSweden
- Study dates
- 13 Jun 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Managers:
- First line manager of nursing or laboratory staff in hospital care
- Employees:
- Having a first-line manager who participates in the study
Who cannot join
- Managers:
- Less than 6 months' work experience as a manager at baseline measurement
- Less than 50 % employment as a manager
- Employees:
- Casual worker
- Exclusion criterium only for the diary and actigraphy study (employees):
- Less than 6 months' work experience in profession at baseline measurement
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg
- Recruiting
Karolinska Universitetssjukhuset
Stockholm
About this study
Official title: Leadership for Recovery: Effects of an Intervention Programme for First-line Healthcare Managers on Employees' Recovery
The goal of this intervention study is to evaluate a group intervention programme that aims to support first-line healthcare managers in promoting their employees' recovery through a "leadership for recovery".
In the study, the researchers will investigate if the intervention programme can improve the recovery (including sleep) of healthcare employees. The intervention programme consists of 6 group sessions for managers.
Read more
The main question the study aims to answer are:
- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' leadership for recovery improve their employees' recovery?
The intervention programme will be delivered to first-line healthcare managers in Swedish hospital care settings. Researchers will compare survey, diary and actigraphy data between employees of 1) managers who participate in the programme and 2) managers who has not participated in the programme.
Read the detailed description
Background
Healthcare staff are often subjected to high workload and insufficient opportunities for recovery. Recovery (including sleep) is an important factor for good health and performance , not least during periods of high stress and strain. Previous research has shown that leadership and organisational factors play a major role in employee health and performance. However, managers in healthcare often report a demanding work situation themselves, which might affect their own health and become an obstacle for the leadership. Thus, healthcare managers have a key role in promoting their employees' recovery, but to be able to manage that important task, they may also need support for managing their own recovery. Furthermore, there is a lack of research on how healthcare managers can work with supporting employees' recovery.
In a previous research project, the investigators developed and evaluated a group-administered proactive recovery programme for new nurses, focusing on enhancing beneficial strategies for recovery. The programme showed promising effects in terms of reduced burnout and fatigue symptoms. However, the intervention was directed only towards the employees, on the individual level. A focus on interactions with organisational factors and leadership is likely needed to support long-term recovery among healthcare staff.
Aims
To evaluate an intervention programme, "Leadership for recovery", for first-line healthcare managers in Swedish hospital settings, focusing on both 1) strategies for promoting own recovery and 2) strengthening a "leadership for recovery" (a leadership that promotes employee recovery).
The main question the study aims to answer are:
- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' own recovery and leadership for recovery improve their employees' recovery?
The hypotheses are:
The leadership for recovery program will:
- improve the employees' recovery (including sleep)
- improve the employees' health, including somatic symptoms and burnout symptoms
- improve the employees' cognition
- reduce the employees' work interference with personal life
- reduce the employees' intention to leave work
Research design
The study is a cluster randomised controlled trial. Participating managers will be randomised to either intervention group or control group. Employees of managers in both the intervention and control group will be invited to participate in the study. Thus, the employees are beforehand (before recruitment) already assigned (cluster randomised) to intervention or control group based on which group their manager belongs to.
Recruitment
Managers are recruited from Swedish hospitals through contacts with Human Resources Departments and second-line managers. All employees of participating managers will be invited via e-mail for participation in the study.
Procedure
The intervention programme for managers includes both educative and reflective parts with a focus on promoting strategies for recovery. It is based on previous interview studies with nurses and first-line healthcare managers (unpublished results), previous interventions for a health promoting leadership, our previously evaluated recovery programme for nurses, and organisational behavioural management techniques. The first parts of the programme focus mostly on managers' own recovery, and the latter parts focus on ways to promote employees' recovery. The programme consists of 6 group sessions distributed over approximately 6 months.
Employees in both intervention and control group will fill out surveys at baseline (before intervention group managers' start the leadership intervention) post-intervention (about 1 month after intervention group managers' fifth session) and at follow-up (12 months after baseline). A subsample (voluntary) will also fill out diaries and wear actigraphy wristbands (objective sleep measure) at baseline and follow-up. Employees in the intervention and control group will be compared in terms of effects of the programme. Primary outcomes will be measures of recovery (including sleep). Secondary outcomes include measures of general health; somatic symptoms; burnout symptoms; cognition and work performance; work interference with personal life and intention to leave work. Both primary and secondary outcomes will be measured in both surveys and diaries. Sleep will also be measured through actigraphy wristbands. Data from surveys and diaries/actigraphy will be analysed and reported separately.
Randomisation and masking
The randomisation will be performed by a person not working in the project that is blinded to the participants. Block randomisation will be used. The randomisation will be made separately for different hospital sites (i.e. managers from the same hospital site will be randomised together, so that the ratio will be 1:1 for intervention/control group in each hospital site if possible). The randomisation may occur continuously as participants sign up for the study. If two or more managers work at the same unit/ward (shared leadership) they will be assigned to the same group.
It is not possible for participants or group leaders to be blinded to group allocation.
Sample size
The aim is to recruit approximately 80 first-line healthcare managers to be randomized to intervention or control group. Employees of participating managers will be invited to participate in the study. Based on the assumption that every manager has ≈ 40 employees, in total ≈ 3200 employees will be invited to participate. The investigators expect approximately 30% to sign up for the study, i.e. 960 participants.
Drop out from the program
Managers who drop out of the leadership program will be asked if they are willing to continue filling out questionnaires.
Data analysis plan
To be published. The analyses will follow the intention to treat principle. Per-protocol analysis will also be conducted.
- Conditions
- Recovery, Psychological, Sleep, Burnout, Work Related Stress, Insomnia, Fatigue
- Being tested
- Leadership for recovery
- Medical subject headings
- Burnout, Psychological, Occupational Stress, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadership for recoveryBehavioural
The intervention will be delivered as a group-based programme (6 sessions) to the managers of the included employees. The programme includes educative and reflective parts as well as various strategies promoting both managers' own recovery and the recovery of employees.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this arm includes employees of managers in the intervention group (that are participating in the intervention programme). Receives: Behavioral: Leadership for recovery |
| Wait-list control group | No intervention | Participants in this arm includes employees of managers randomised to the control group (that are not participating in the intervention programme during the study period). Managers randomised to the control group will be offered to participate in the intervention programme after the last follow-up assessment. No further employee assessments will be made after the follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey measure of recovery experiences
Psychological detachment from work and Relaxation indexes from the Recovery Experience Questionnaire. + Additional single items on experiences of active recovery experiences.
Minimum mean score 1, maximum mean score 5 (of each subscale/items). Lower scores indicate worse psychological detachment, worse relaxation and less active recovery experiences respectively.
Single items: Do you get sufficient sleep? and Beyond sleep, do you get sufficient recovery? (1 yes, definitely sufficient - 5 no, far from sufficient)
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of need for recovery after work
Short-form versions of the Need For Recovery Scale, in total 5 items about work-induced fatigue. Minimum score 1, maximum score 5. Higher scores indicate a higher need for recovery.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of insomnia symptoms
Insomnia Severity Index (ISI) which consists of 7 questions related to sleep. The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more insomnia symptoms/sleep problems.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Diary measure of recovery experiences during work and off-work time
Single items measured in diary study. During work today, I had time for reflection, I experienced periods of extreme fatigue, I could take breaks when needed, I had a good variety in work tasks, shift hand-overs worked out well, I detached from work when leaving. And Today during free-time, I did relaxing things, I did things that gave me energy, I took time for leisure, I had a break from the demands at work, I distanced myself from work, I was not disturbed by work-related questions.
Rated from 1 = do not agree - 5 = totally agree.
Measured: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Sleep (objective measure)
Actigraphy (wristband). Measuring of movements during sleep through a sensitive accelerometer. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Example of parameters that can be estimated:
Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation.
Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time.
Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts <=1min (%)". This is an indication of the degree of fragmentation
Measured: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Secondary outcomes (8)
Survey measure of general health
Single item: Self-rated health during the last month on a scale ranging from 1=very good to 7=very bad.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of somatic symptom burden
Somatic Symptoms Scale-8. Minimum score 0, maximum score 32. Higher scores indicate higher somatic symptom burden.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of burnout symptoms
Shirom-Melamed Burnout Questionnaire-12 [SMBQ-12]: Minimum score 1, maximum score 7. Higher scores indicate more burnout.
Index Emotional Impairment from Burnout Assesment Tool-12: Minimum score 1, maximum score 5. Higher scores indicate higher levels of emotional impairment.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of cognition and work performance
Ratings (single items). Self-rated work performance through the following items: During the past month how often have you during you work .... 1) experienced a risk of mistakes 2) found it hard to make decisions 3) been present during interaction with others 4) experienced that you could perform your work safely (1 = never, 5 = always).
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of intention to leave work
Item from COpenhagen PsychoSOcial Questionnaire (COPSOQ): How often do you consider looking for work elsewhere? 1 always - 5 never/hardly ever.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of work interference with personal life
The Work Interference with Personal Life index from the Work Home Interference scale. Consists of four items measuring the extent to which work affects free time (1 not at all-5 almost all the time). Higher scores indicate more work-home interference.
Measured: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Diary measure of stress/health symptoms
Single items measured in diary study. Questions if the respondent felt e.g. tense, irritated, exhausted, fatigued, emotionally strained, engaged, unfocused or had difficulties detaching from thoughts at work during free-time, during the day. Rated from 1 not at all - 5 to a high degree.
Measured: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Diary measure of cognition and work performance
Ratings (single items) in diary study. Self-rated cognitive function through the following items: During the day at work, how well did you manage the following aspects: 1) decision making, 2) keeping things in mind, 3) keeping the overall picture, 4) performing work safely and 5) being present during interaction with others. rated from 1 = very well, 5 = very bad).
Measured: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start13 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Recovery, PsychologicalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Dahlgren, Karolinska Institutet
- Investigators
- Anna Dahlgren, Docent, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678347
- Sponsor's protocol ID
- AFA230022_1
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data from this study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis
Publications
Dahlgren A, Tucker P, Epstein M, Gustavsson P, Soderstrom M. Randomised control trial of a proactive intervention supporting recovery in relation to stress and irregular work hours: effects on sleep, burn-out, fatigue and somatic symptoms. Occup Environ Med. 2022 Jul;79(7):460-468. doi: 10.1136/oemed-2021-107789. Epub 2022 Jan 24.
PubMed 35074887Dellve L, Eriksson A. Health-Promoting Managerial Work: A Theoretical Framework for a Leadership Program that Supports Knowledge and Capability to Craft Sustainable Work Practices in Daily Practice and During Organizational Change. Societies. 2017;7(2):12.
Eriksson A, Dellve L. Learning Processes as Key for Success in Workplace Health Promotion Interventions in Health Care. Front Public Health. 2020 Nov 10;8:576693. doi: 10.3389/fpubh.2020.576693. eCollection 2020.
PubMed 33304874Geurts SA, Sonnentag S. Recovery as an explanatory mechanism in the relation between acute stress reactions and chronic health impairment. Scand J Work Environ Health. 2006 Dec;32(6):482-92. doi: 10.5271/sjweh.1053.
PubMed 17173204Kecklund G, Axelsson J. Health consequences of shift work and insufficient sleep. BMJ. 2016 Nov 1;355:i5210. doi: 10.1136/bmj.i5210.
PubMed 27803010Skakon J, Nielsen K, Borg V, Guzman J. Are leaders' well-being, behaviours and style associated with the affective well-being of their employees? A systematic review of three decades of research. Work and stress. 2010;24(2):107-39.
Sonnentag S. The recovery paradox: Portraying the complex interplay between job stressors, lack of recovery, and poor well-being. Research in organizational behavior. 2018;38:169-85.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leadership for Recovery: Effects of an Intervention Programme for First-line Healthcare Managers on Employees' Recovery
- ClinicalTrials.gov ID
- NCT06678347
- Acronym / sponsor ID
- AFA230022_1
- Conditions
- Recovery, Psychological, Sleep, Burnout, Work Related Stress, Insomnia, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention study is to evaluate a group intervention programme that aims to support first-line healthcare managers in promoting their employees' recovery through a "leadership for recovery".
In the study, the researchers will investigate if the intervention programme can improve the recovery (including sleep) of healthcare employees. The intervention programme consists of 6 group sessions for managers.
The main question the study aims to answer are:
- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' leadership for recovery improve their employees' recovery?
The intervention programme will be delivered to first-line healthcare managers in Swedish hospital care settings. Researchers will compare survey, diary and actigraphy data between employees of 1) managers who participate in the programme and 2) managers who has not participated in the programme.
Detailed description
Background
Healthcare staff are often subjected to high workload and insufficient opportunities for recovery. Recovery (including sleep) is an important factor for good health and performance , not least during periods of high stress and strain. Previous research has shown that leadership and organisational factors play a major role in employee health and performance. However, managers in healthcare often report a demanding work situation themselves, which might affect their own health and become an obstacle for the leadership. Thus, healthcare managers have a key role in promoting their employees' recovery, but to be able to manage that important task, they may also need support for managing their own recovery. Furthermore, there is a lack of research on how healthcare managers can work with supporting employees' recovery.
In a previous research project, the investigators developed and evaluated a group-administered proactive recovery programme for new nurses, focusing on enhancing beneficial strategies for recovery. The programme showed promising effects in terms of reduced burnout and fatigue symptoms. However, the intervention was directed only towards the employees, on the individual level. A focus on interactions with organisational factors and leadership is likely needed to support long-term recovery among healthcare staff.
Aims
To evaluate an intervention programme, "Leadership for recovery", for first-line healthcare managers in Swedish hospital settings, focusing on both 1) strategies for promoting own recovery and 2) strengthening a "leadership for recovery" (a leadership that promotes employee recovery).
The main question the study aims to answer are:
- Can a group-based intervention programme with a focus on strengthening first-line healthcare managers' own recovery and leadership for recovery improve their employees' recovery?
The hypotheses are:
The leadership for recovery program will:
- improve the employees' recovery (including sleep)
- improve the employees' health, including somatic symptoms and burnout symptoms
- improve the employees' cognition
- reduce the employees' work interference with personal life
- reduce the employees' intention to leave work
Research design
The study is a cluster randomised controlled trial. Participating managers will be randomised to either intervention group or control group. Employees of managers in both the intervention and control group will be invited to participate in the study. Thus, the employees are beforehand (before recruitment) already assigned (cluster randomised) to intervention or control group based on which group their manager belongs to.
Recruitment
Managers are recruited from Swedish hospitals through contacts with Human Resources Departments and second-line managers. All employees of participating managers will be invited via e-mail for participation in the study.
Procedure
The intervention programme for managers includes both educative and reflective parts with a focus on promoting strategies for recovery. It is based on previous interview studies with nurses and first-line healthcare managers (unpublished results), previous interventions for a health promoting leadership, our previously evaluated recovery programme for nurses, and organisational behavioural management techniques. The first parts of the programme focus mostly on managers' own recovery, and the latter parts focus on ways to promote employees' recovery. The programme consists of 6 group sessions distributed over approximately 6 months.
Employees in both intervention and control group will fill out surveys at baseline (before intervention group managers' start the leadership intervention) post-intervention (about 1 month after intervention group managers' fifth session) and at follow-up (12 months after baseline). A subsample (voluntary) will also fill out diaries and wear actigraphy wristbands (objective sleep measure) at baseline and follow-up. Employees in the intervention and control group will be compared in terms of effects of the programme. Primary outcomes will be measures of recovery (including sleep). Secondary outcomes include measures of general health; somatic symptoms; burnout symptoms; cognition and work performance; work interference with personal life and intention to leave work. Both primary and secondary outcomes will be measured in both surveys and diaries. Sleep will also be measured through actigraphy wristbands. Data from surveys and diaries/actigraphy will be analysed and reported separately.
Randomisation and masking
The randomisation will be performed by a person not working in the project that is blinded to the participants. Block randomisation will be used. The randomisation will be made separately for different hospital sites (i.e. managers from the same hospital site will be randomised together, so that the ratio will be 1:1 for intervention/control group in each hospital site if possible). The randomisation may occur continuously as participants sign up for the study. If two or more managers work at the same unit/ward (shared leadership) they will be assigned to the same group.
It is not possible for participants or group leaders to be blinded to group allocation.
Sample size
The aim is to recruit approximately 80 first-line healthcare managers to be randomized to intervention or control group. Employees of participating managers will be invited to participate in the study. Based on the assumption that every manager has ≈ 40 employees, in total ≈ 3200 employees will be invited to participate. The investigators expect approximately 30% to sign up for the study, i.e. 960 participants.
Drop out from the program
Managers who drop out of the leadership program will be asked if they are willing to continue filling out questionnaires.
Data analysis plan
To be published. The analyses will follow the intention to treat principle. Per-protocol analysis will also be conducted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Leadership for recoveryParticipants in this arm includes employees of managers in the intervention group (that are participating in the intervention programme). |
| Wait-list control group | No intervention | –Participants in this arm includes employees of managers randomised to the control group (that are not participating in the intervention programme during the study period). Managers randomised to the control group will be offered to participate in the intervention programme after the last follow-up assessment. No further employee assessments will be made after the follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First line manager of nursing or laboratory staff in hospital care
- Having a first-line manager who participates in the study
Key exclusion criteria (7 listed)
- Less than 6 months' work experience as a manager at baseline measurement
- Less than 50 % employment as a manager
- Casual worker
- Less than 6 months' work experience in profession at baseline measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadership for recoveryThe intervention will be delivered as a group-based programme (6 sessions) to the managers of the included employees. The programme includes educative and reflective parts as well as various strategies promoting both managers' own recovery and the recovery of employees. | Behavioural | Intervention group |
Primary outcome
Survey measure of recovery experiences
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Psychological detachment from work and Relaxation indexes from the Recovery Experience Questionnaire. + Additional single items on experiences of active recovery experiences. Minimum mean score 1, maximum mean score 5 (of each subscale/items). Lower scores indicate worse psychological detachment, worse relaxation and less active recovery experiences respectively. Single items: Do you get sufficient sleep? and Beyond sleep, do you get sufficient recovery? (1 yes, definitely sufficient - 5 no, far from sufficient)
Survey measure of need for recovery after work
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Short-form versions of the Need For Recovery Scale, in total 5 items about work-induced fatigue. Minimum score 1, maximum score 5. Higher scores indicate a higher need for recovery.
Survey measure of insomnia symptoms
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Insomnia Severity Index (ISI) which consists of 7 questions related to sleep. The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more insomnia symptoms/sleep problems.
Diary measure of recovery experiences during work and off-work time
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Single items measured in diary study. During work today, I had time for reflection, I experienced periods of extreme fatigue, I could take breaks when needed, I had a good variety in work tasks, shift hand-overs worked out well, I detached from work when leaving. And Today during free-time, I did relaxing things, I did things that gave me energy, I took time for leisure, I had a break from the demands at work, I distanced myself from work, I was not disturbed by work-related questions. Rated from 1 = do not agree - 5 = totally agree.
Sleep (objective measure)
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Actigraphy (wristband). Measuring of movements during sleep through a sensitive accelerometer. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Example of parameters that can be estimated: Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation. Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time. Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts <=1min (%)". This is an indication of the degree of fragmentation
8 secondary outcomes
Survey measure of general health
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of somatic symptom burden
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of burnout symptoms
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of cognition and work performance
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of intention to leave work
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Survey measure of work interference with personal life
Time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).
Diary measure of stress/health symptoms
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Diary measure of cognition and work performance
Time frame: 7 days at pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), 7 days at follow-up (approx. 1 year after baseline measurement).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 35074887Dahlgren A, Tucker P, Epstein M, Gustavsson P, Soderstrom M. Randomised control trial of a proactive intervention supporting recovery in relation to stress and irregular work hours: effects on sleep, burn-out, fatigue and somatic symptoms. Occup Environ Med. 2022 Jul;79(7):460-468. doi: 10.1136/oemed-2021-107789. Epub 2022 Jan 24.
- BackgroundDellve L, Eriksson A. Health-Promoting Managerial Work: A Theoretical Framework for a Leadership Program that Supports Knowledge and Capability to Craft Sustainable Work Practices in Daily Practice and During Organizational Change. Societies. 2017;7(2):12.
- Background: PubMed 33304874Eriksson A, Dellve L. Learning Processes as Key for Success in Workplace Health Promotion Interventions in Health Care. Front Public Health. 2020 Nov 10;8:576693. doi: 10.3389/fpubh.2020.576693. eCollection 2020.
- Background: PubMed 17173204Geurts SA, Sonnentag S. Recovery as an explanatory mechanism in the relation between acute stress reactions and chronic health impairment. Scand J Work Environ Health. 2006 Dec;32(6):482-92. doi: 10.5271/sjweh.1053.
- Background: PubMed 27803010Kecklund G, Axelsson J. Health consequences of shift work and insufficient sleep. BMJ. 2016 Nov 1;355:i5210. doi: 10.1136/bmj.i5210.
- BackgroundSkakon J, Nielsen K, Borg V, Guzman J. Are leaders' well-being, behaviours and style associated with the affective well-being of their employees? A systematic review of three decades of research. Work and stress. 2010;24(2):107-39.
- BackgroundSonnentag S. The recovery paradox: Portraying the complex interplay between job stressors, lack of recovery, and poor well-being. Research in organizational behavior. 2018;38:169-85.
- Individual participant dataSharing planned: No. Individual participant data from this study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Dahlgren, Docent principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leadership for recovery in people with Recovery, Psychological and Sleep, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Dahlgren, Docent (+46852483227, anna.dahlgren@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey measure of recovery experiences (time frame: Pre-intervention/baseline (approx. 1 month before managers starts leadership intervention), post-intervention (approx. 1 month after managers 5th intervention programme session), follow-up (1 year after baseline measurement).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678347, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.