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Table 2 Example of a trial estimand employing a treatment policy strategy

From: Evaluation of randomized controlled trials: a primer and tutorial for mental health researchers

Attribute

Example

1. Treatment conditions

Internet-based, 8-week intervention for subthreshold depression with full access to care as usual, versus one-session psychoeducation with full access to care as usual.

2. Population

Elderly individuals (≥ 65 years) with mild depression (PHQ-9 ≥ 10) who do not fulfill diagnostic criteria of a major depressive episode according to the DSM-5.

3. Intercurrent events

Treatment policy strategy: effect regardless of treatment discontinuation (i.e., not completing all intervention sessions as intended) or use of other treatments (e.g., conventional psychotherapy or pharmacotherapy).

4. Endpoint

PHQ-9 depressive symptom severity score 8 weeks after randomization (post-test), measured regardless of intercurrent events.

5. Summary measure

Mean treatment group difference in the endpoint, expressed as a standardized mean difference (Cohen’s d), with the pooled post-test SD used for standardization.

  1. DSM-5 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, PHQ-9 Patient Health Questionnaire 9