F32 F33
Conditions
Interventions
Group 1: Cognitive Behavioral Therapy with a Return-to-Work Focus (RTW-CBT) (Short-Term Therapy I + Short-Term Therapy II, maximum total of 28 sessions)
Group 2: Cognitive Behavioral Therapy Provided
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Statutorily insured with AOK Niedersachsen • Currently employed • Aged between 18 and 60 years • Currently on sick leave due to a diagnosis of depression (F32.0, F32.1, F32.2, F32.8, F32.9, F33.0, F33.1, F33.2, F33.8, F33.9, F34.1) • Current sickness absence of at least 42 days at the time of randomization
Exclusion criteria
Exclusion criteria: • Risk of early retirement due to reduced earning capacity (F0, F72, F73) • Receipt of unemployment benefit I or citizen’s allowance (Bürgergeld) • Currently receiving (partial) inpatient or outpatient guideline-based psychotherapy • Not suitable for outpatient treatment (F0X.X, F2X.X, F7X.X) • As sufficient German language skills are required for psychotherapeutic treatment, individuals with German proficiency below B1 level are excluded from study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary Endpoint 1 (Superiority Hypothesis) WHAT: Number of sick leave days until full return to work within 12 months after randomization WHEN: 12 months after randomization HOW: Insurance data from AOK Niedersachsen (sick leave days) Co-primary Endpoint 2 (Non-Inferiority Hypothesis) WHAT: Change in depressive symptoms within 12 months after randomization WHEN: 12 months after randomization HOW: Beck Depression Inventory II (BDI-II) change scores (randomization vs. 12 months after randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine whether RTW-CBT differs from TAU-CBT with respect to the number of sick leave days until full return to work and improvement in depressive symptoms 12 months after randomization, including subgroup analyses (e.g., age, sex, severity of depression, personality characteristics). In addition, group differences in cumulative sick leave days within 12 months will be analyzed. Furthermore, changes in additional psychometric dimensions (anxiety, social isolation, loneliness, quality of life, life satisfaction, general somatic symptoms, job-related anxiety, and return-to-work-related self-efficacy) will be assessed and compared between groups. These outcomes will be measured at four time points (baseline; after 12 sessions or end of therapy; after 24 sessions or end of therapy; and 12 months after randomization) to evaluate baseline psychosocial burden and temporal patterns of change. | — |
Countries
Germany
Contacts
Public ContactIvo Heitland
Medizinische Hochschule Hannover
Outcome results
None listed