F32.9
Conditions
Interventions
Group 1: A manual-based interpersonal group intervention with a specific focus on the work context of 10 sessions over 8 weeks (twice weekly in the first 2 weeks and weekly thereafter) of 90 minutes d
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient's written informed consent has been obtained 2. Primary diagnosis of Major Depression/MD (single-episode or recurrent) according to the Structured Clinical Interview for DSM-5 (SCID-5-CV; also ICD-10 coded; assessment not older than 14 days on the day of randomisation request) 3. A score of = 17 on the 24-item version of the Hamilton Rating Scale for Depression (HRSD-24; assessment not older than 14 days on the day of randomisation request) 4. A total score of at least 15 on the Occupational Depression Inventory (ODI; assessment not older than 14 days on the day of randomisation request) 5. Sick leave related to depressive or burn-out complaints for at least 7 days during the last 12 months 6. Sufficient German language skills 7. Outpatient status 8. 18-years or older 9. Patients must have a regular work activity that is expected to continue for at least 6 months at the time of randomisation.
Exclusion criteria
Exclusion criteria: 1. Acute risk of suicide 2. History of psychotic symptoms, bipolar disorder, or organic brain disorders 3. A primary diagnosis of another SCID-5-CV disorder 4. Concurrent diagnosis of substance dependency 5. Antisocial, schizotypal, or borderline personality disorder (SCID-5-PD) 6. Other ongoing psychotherapy 7. Antidepressive pharmacotherapy (if not stable for at least the last 4 weeks before randomisation) 8. Serious medical condition or time restrictions interfering with participation in regular sessions 9. Current sick leave > 4 weeks 10. Applying for rehabilitation or early retirement 11. Patient without legal capacity who is unable to understand the nature, significance and consequences of the study 12. Simultaneous participation in other studies which could interfere with this study and/or participation before the end of a required restriction period. No prior randomisation in this IPT-Work trial. 13. Persons who are in a disciplinary employment relationship with a member of the study team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in HRSD-24 score from baseline to follow-up 3 months after end of treatment (100 – (100 x post/pre) %); IPT-Work vs. SP | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change in HRSD-24 scores from baseline at post-treatment 9 weeks after randomisation; Occupational Depression Inventory (ODI), Beck Depression Inventory-II (BDI-II), Work Ability Index (WAI), Return to Work Attitude (RTW-SE), Effort-Reward-Imbalance (ERI), Quality of Life (WHOQOL-BREF), and Connor-Davidson Resilience Scale (CD-RISC) at post-treatment and follow-up. In addition, remission (HRSD-24 <9) and response (reduction in the HRSD-24 score by at least 50% from baseline) rates at post-treatment and follow-up. Days of sick leave throughout the study period. | — |
Countries
Germany
Contacts
Public ContactElisabeth Schramm
Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed