Depression according to DSM-5 I61 I63 F32
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Occurrence of ischemic stroke (ICD-Code: I.63) and intracerebral hemorrhage (I.61) in patients admitted to the two participating Stroke Units Düsseldorf and Heidelberg. 2) Sufficient verbal comprehension at baseline (T0) as defined by sum of = 6 points of the shortened Aphasie-Schnell-Test (AST)3) Sufficient German language comprehension for questionnaire completion and participation in psychotherapy. 4) Depression (i.e., a PHQ-9 score = 11) after discharge from inpatient rehabilitation (T1)
Exclusion criteria
Exclusion criteria: 1) patients with transitory ischemic attack (TIA: ICD-Code G.45) 2) Patients with severe intracerebral hemorrhage, requiring neurosurgical treatment shortly after stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is 1) RCT recruitment feasibility and 2) intervention acceptability defined as: 1) recruitment rate (i.e., consent to randomization) of >=20% of eligible patients at T1 (i.e., self-reported PHQ >= 11 at the screening after discharge from inpatient rehabilitation 2) Treatment completion (i.e., participation in >=66% of all therapy sessions) of >=70% in the intervention group | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, changes in depression (PHQ-9/HAMD-D) and anxiety (GAD-7) across all follow-ups (T1 and T2) will tested using uni- and multivariate ANOVA with repeated measurements. | — |
Countries
Germany
Contacts
Klinisches Instituts für Psychosomatische Medizin und Psychotherapie