Clinical Trial: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Burnout, Adjustment Disorder or Psychological Stress in Denmark (the Danish

Brief Summary: 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

Detailed Summary:

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 hea
Sponsor: Mental Health Centre Copenhagen

Current Primary Outcome: Time to return to work [ Time Frame: 12 months ]

Time from baseline to first return to work for more than four consecutive weeks


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Work [ Time Frame: 12 months ]
    Competitive work 12 months after baseline (yes/no)
  • Time to return to work [ Time Frame: 24 months ]
    Time from baseline to first return to work for more than four consecutive weeks
  • Recurrent Sickness Absence [ Time Frame: 24 months ]
    Time from baseline to recurrent sickness absence for more than 8 weeks
  • Degree of depressive symptoms [ Time Frame: 6 months ]
    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)
  • Degree of anxiety symptoms [ Time Frame: 6 months ]
    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
  • Degree of psychological stress symptoms [ Time Frame: 6 months ]
    Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
  • Work and social functioning [ Time Frame: 6 months ]
    Work and social functioning by the Work and Social Adjustment Scale (WSAS)


Original Secondary Outcome: Same as current

Information By: Mental Health Centre Copenhagen

Dates:
Date Received: August 15, 2016
Date Started: April 2016
Date Completion: August 2020
Last Updated: April 6, 2017
Last Verified: April 2017