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Table 1 Participant timeline

From: Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention

Time point

Baseline

During or immediately after the intervention

6 months

12 months

Enrolment

 Eligibility screening

X

   

 Informed consent

X

   

 WHO-5 screena

X

   

Intervention

 Problem-solving therapy (1–7 sessions)

 

X

  

Assessments

 Primary outcome

  PHQ-9

X

 

X

X

 Secondary outcomes

  WHO-5

X

 

X

X

  GAD-7

X

 

X

X

  PAID-5b

X

 

X

X

  HbA1cb

X

  

X

  Total cholesterol

X

  

X

  LDL

X

  

X

Process outcomes

 Implementation

  Fidelity

 

X

  

  Dose

 

X

  

  Reach

 

X

  

 Mechanisms of impact

  Mediators

 

X

  

  Unintended consequences

 

X

  
  1. aOnly patients with WHO-5 point score < 50 proceed in the study
  2. bOnly patients with T2D