Mental Health Services of the Capital Region of Denmark
Copenhagen, Capital Region of Denmark, 2100, Denmark
NCT Number: NCT02872051
The purpose of this 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 depression and anxiety in Denmark
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Capital Region of Denmark, 2100, Denmark
Background:
Depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in Denmark have common mental disorders like depression and anxiety. 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 examine 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 depression and anxiety 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 depression and anxiety 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 Cognitive-behavior Therapy Monitoring and reassessment
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 Cognitive-behavior Therapy Monitoring and reassessment
Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element
Time frame: 12 months
Time from baseline to first return to work for more than four consecutive weeks
Time frame: 12 months
Competitive work 12 months after baseline (yes/no)
Time frame: 24 months
Time from baseline to first return to work for more than four consecutive weeks
Time frame: 24 months
Time from baseline to recurrent sickness absence for more than 8 weeks
Time frame: 6 months
Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)
Time frame: 6 months
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
Time frame: 6 months
Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
Time frame: 6 months
Work and social functioning by the Work and Social Adjustment Scale (WSAS)
Time frame: 6, 12 and 24 months
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 and cause of death by register data
Time frame: 6, 12 and 24 months
Suicidal ideation by BDI
Time frame: 6, 12 and 24 months
Life-threatening conditions by register data
Amager Hospital
Other
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
Acronym: IBBIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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