The effect of IPS-modified, an early intervention for people with mood and anxiety disorders: study protocol for a randomised clinical superiority trial.

backgroundAnxiety and affective disorders can be disabling and have a major impact on the ability to work. In Denmark, people with a mental disorder, and mainly non-psychotic disorders, represent a substantial and increasing part of those receiving disability pensions. Previous studies have indicated that Individual Placement and Support (IPS) has a positive effect on employment when provided to people with severe mental illness. This modified IPS intervention is aimed at supporting people with recently diagnosed anxiety or affective disorders in regaining their ability to work and facilitate their return to work or education.

aimTo investigate whether an early modified IPS intervention has an effect on employment and education when provided to people with recently diagnosed anxiety or affective disorders in a Danish context. METHODS/

designThe trial is a randomised, assessor-blinded, clinical superiority trial of an early modified IPS intervention in addition to treatment-as-usual compared to treatment-as-usual alone for 324 participants diagnosed with an affective disorder or anxiety disorder living in the Capital Region of Denmark. The primary outcome is competitive employment or education at 24 months. Secondary outcomes are days of competitive employment or education, illness symptoms and level of functioning including quality of life at follow-up 12 and 24 months after baseline. DISCUSSION: If the modified IPS intervention is shown to be superior to treatment-as-usual, a larger number of disability pensions can probably be avoided and long-term sickness absences reduced, with major benefits to society and patients. This trial will add to the evidence of how best to support people's return to employment or education after a psychiatric disorder.

trial registrationNCT01721824.