Table 1.
Example template of recommended content for the schedule of enrolment, interventions, and assessments.
| STUDY PERIOD | |||||||
|---|---|---|---|---|---|---|---|
| Enrolment | Allocation | Post-Allocation | Close-Out | ||||
| TIMEPOINT * | −t1 | 0 | t1 | t2 | t3 | t4 | |
| ENROLMENT: | X | ||||||
| Eligibility screen | X | ||||||
| Informed consent | X | ||||||
| Filling the questionnaires | |||||||
| Allocation | X | ||||||
| INTERVENTIONS: | |||||||
| EMDR + TF-CBT |
|
X | X | ||||
| TF-CBT + EMDR |
|
X | X | ||||
| ASSESSMENTS: | |||||||
| Satisfaction with life scale (SWLS) | X | X | X | X | |||
| Rosenberg Self-Esteem Scale (RSE) | X | X | X | X | |||
| Symptom Checklist-90-Revised (SCL-R) | X | X | X | X | |||
| Post-traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R) | X | X | X | X | |||
| DSM-5 Personality Inventory—Brief Version (PID-5-BF) Adults | X | X | |||||
| Scale of emotional regulation difficulties (DERS) | X | X | X | X | |||
| Dissociative Symptom Scale (DES) | X | X | X | X | |||
| Scale of satisfaction with the treatment received. (CRES-4) | X | X | |||||
| Ad-hoc registry for general sociodemographic and clinical variables | X | ||||||
Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols. * List specific timepoints in this row. Intervention A: EMDR + TF-CBT. The group receives the EMDR treatment first, and afterwards, the TF-CBT Intervention B: TF-CBT + EMDR. The group receives the TF-CBT treatment first, and afterwards, the EMDR.