Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment | Baseline | Allocation | Intervention | Follow-up | ||||
Time point | -T1 | T0 | TA | TInt | T1 | T2 | T3 | T4 |
Enrolment | ||||||||
Patients and relatives | ||||||||
Eligibility screening | x | |||||||
Informed consent | x | |||||||
Allocation | x | |||||||
Intervention | ||||||||
Psychoeducational group intervention | x | |||||||
Adherence and competence of therapistsa/IG | x | |||||||
Self-rating | ||||||||
Patient-related | ||||||||
Symptom self-rating (PHQ-9, Core set) | x | x | x | x | x | |||
Rehospitalisations (FIMA, CSSRI-D) | x | x | x | x | ||||
Health care and medication consumption (FIMA, CSSRI-D) | x | x | x | x | ||||
Employment statusa | x | x | x | x | x | |||
Days of incapacity to work (DEGS) | x | x | x | x | ||||
Functional capability, activity and participation (WHODAS 2.0) | x | x | x | x | x | |||
General state of health (DEGS) | x | x | x | x | x | |||
Perceived expressed emotion (FEF) | x | x | x | |||||
Perceived criticism (PCS) | x | x | x | |||||
Adverse eventsa/IG | x | x | ||||||
Clinical characteristicsa | x | |||||||
Demographic informationa | x | |||||||
Relative-related | ||||||||
Psychosocial burden (SCL-K-9) | x | x | x | x | x | |||
Disease-related burden (IEQ-EU) | x | x | x | x | x | |||
General state of health (DEGS) | x | x | x | x | x | |||
Problem-solving competency (SPSI-R-S) | x | x | x | |||||
Implementation of problem-solvinga | x | x | x | |||||
Depression literacy (D-Lit)a | x | x | ||||||
Control attributions (IPQS-R) | x | x | x | |||||
Expressed emotion (FQ) | x | x | x | |||||
Health care utilisation (FIMA) | x | x | x | x | x | |||
Employment statusa | x | x | x | x | x | |||
Acceptance and subjective benefit of the interventiona/IG | x | |||||||
Adverse Eventsa/IG | x | x | ||||||
Demographic informationa | x |