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Table 2 A Sequential Multiple, Assignment Randomized Trial (SMART) of non-specialist-delivered psychotherapy and/or medication for Major Depressive Disorder and Posttraumatic Stress Disorder (DAPPER)

From: Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya

 

Enrollment

Allocation

Post-allocation

Close-out

TIMEPOINT

 

Baseline

1.5 m

3 m

6 m

9 m

12 m

18 m

24 m

30 m

ENROLLMENT:

 

X

        

 Eligibility screen

X

         

 Informed consent

X

         

 Random Allocation

 

X

        

INTERVENTIONS:

 Intervention A

IPT

X

X

X

      

 Intervention B

F

X

X

X

X

     

 Intervention C (non-remitters)

IPT, IPT (RR)

X

X

X

X

     

 Intervention D (non-remitters)

IPT, F (RR)

X

X

X

X

X

    

 Intervention E (non-remitters)

F, IPT (RR)

X

X

X

X

X

    

 Intervention F (non-remitters)

F, F (RR)

X

X

X

X

X

X

   

ASSESSMENTS:

 Inclusion and Exclusion Criteria

1. MDD (IC)

2. PTSD (IC)

3. Suicidality (ER)

4. Mania/hypomania (ER)

5. Detailed alcohol use (ER)

6. Pregnancy and breast-feeding (ER)

7. Drug use (ER)

         

 Baseline Variables

1. Demographics

2. Highest education

3. Time and cost of transport

4. Trauma history

5. Depression symptoms

6. PTSD symptoms

7. Emotional Reactivity

8. Domestic violence

9. Social Support

10. Income

11. Health co-morbidities

12. Health-related disability

X

        

 Follow-up Variables

1.MDD

2. PTSD

3. Depression symptoms

4. PTSD symptoms

5. Emotional Reactivity

6. Domestic violence

7. Social Support

8. Income

9. Health co-morbidities

10. Health-related disability

 

X

X

X

X

X

X

X

X

  1. Exclusion and Referral (ER) Fluoxetine (F) Inclusion Criteria (IC) Interpersonal Psychotherapy (IPT) Major Depressive Disorder (MDD) Posttraumatic Stress Disorder (PTSD) Re-Randomization (RR) of non-remitters