An interventional study of IBBIS mental health care and standard vocational rehabilitation and Integrated mental health care and vocational rehabilitation in Adjustment Disorder, Burnout and Psychological Stress, sponsored by Amager Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Amager Hospital · Not applicable, Interventional, and Other
The purpose of this study is to investigate the efficacy of 1) a stepped mental health care (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR) intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark
Background:
Stress disorders have negative effects on workability and have negative effects on both the individual and society. Psychological stress and burnout is not recognized as psychiatric diagnoses, and thus, the estimated prevalence in healthy and sick-listed people is somewhat insecure in Denmark. Together with other common mental disorders, burnout, adjustment disorder and psychological stress are causes of up 40 % of the sick leave claims in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries.
Objective:
The purpose of the Danish IBBIS study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark.
Method:
This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is return to work at 12 months.
Results/discussion:
This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's enrollment of 631 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →Amager Hospital is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard treatment and standard vocational rehabilitation
IBBIS mental health care and standard vocational rehabilitation
Behavioral: IBBIS mental health care and standard vocational rehabilitation
Integrated mental health care and vocational rehabilitation
Behavioral: Integrated mental health care and vocational rehabilitation
Standard vocational rehabilitation. Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists and medical doctors) with the treatment modalities: Psychoeducation Bibliotherapy Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment
Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors). Mental health care is provided according to a stepped care model with the following treatment modalities: Psychoeducation Bibliotherapy Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element
Time to return to work
Time from baseline to first return to work for more than four consecutive weeks
Time frame: 12 months
Work
Competitive work 12 months after baseline (yes/no)
Time frame: 12 months
Time to return to work
Time from baseline to first return to work for more than four consecutive weeks
Time frame: 24 months
Recurrent Sickness Absence
Time from baseline to recurrent sickness absence for more than 8 weeks
Time frame: 24 months
Degree of depressive symptoms
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)
Time frame: 6 months
Degree of anxiety symptoms
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
Time frame: 6 months
Degree of psychological stress symptoms
Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
Time frame: 6 months
Work and social functioning
Work and social functioning by the Work and Social Adjustment Scale (WSAS)
Time frame: 6 months
Symptom level
Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)
Time frame: 6, 12 and 24 months
Death
Death and cause of death by register data
Time frame: 6, 12 and 24 months
Suicidal ideation
Suicidal ideation by BDI
Time frame: 6, 12 and 24 months
Life-threatening conditions
Life-threatening conditions by register data
Time frame: 6, 12 and 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Apr 2016 to primary completion in Jun 2019, 38 months.
Of 25 interventional studies with no phase under Adjustment Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 38 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Amager Hospital