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Table 1 Study schedule and measurements used

From: Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual – study protocol of a multisite randomised controlled trial

 

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

      
  1. -T1, during inpatient treatment; T0, at discharge from inpatient treatment; TA, allocation to intervention or control group; TInt, intervention; Follow-up: T1 = 3 months; T2 = 6 months; T3 = 9 months; T4 = 12 months after discharge from inpatient treatment; CSSRI-D, German version of the Client Sociodemographic and Service Receipt Inventory; DEGS, German Health Interview and Examination Survey for Adults; D-Lit, Depression Literacy Test; FEF, Questionnaire on Family Atmosphere; FIMA, Questionnaire for Health-Related Resource Use; FQ, German version of the Family Questionnaire; IEQ-EU, German Version of the Involvement Evaluation Questionnaire; IPQS-R, scales for control attributions of the Illness Perception Questionnaire for Schizophrenia: Relatives’ version; PCS, Perceived Criticism Scale; PHQ-9, 9-item version of the Patient Health Questionnaire; SCL-K-9, 9-item version of the Symptom-Ckecklist-90-R; SPSI-R-S, 25-item version of the Social Problem-Solving Inventory-Revised; WHODAS 2.0, 36-item version of the WHO Disability Assessment Schedule; aself-constructed items; IGonly administered in the intervention group