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. |