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Table 2 Similarities and differences of randomized controlled trial and randomized clinical implementation trial designs in human interventions

From: How to customize a bona fide psychotherapy for generalized anxiety disorder? A two-arms, patient blinded, ABAB crossed-therapist randomized clinical implementation trial design [IMPLEMENT 2.0]

Design:

Randomized clinical trial

Randomized clinical implementation trial

Treatment manual / protocol:

Contrast between different packages (e.g. comparative, additive, subtractive designs)

Same package over all conditions, contrasts between implementation strategies (e.g. timing, sequence, focus)

Patient allocation:

Randomized, not blinded

Randomized, blinded

Therapist allocation:

Not randomized, not blinded

Randomized or systematic allocation (e.g. ABAB), not blinded

Researcher allegiance:

Substantial

Not investigated yet