Table 1 Pre-specified progression criteria to an efficacy trial

Outcome 1:

Known rate of trial recruitment, retention in treatment, and research

In 14 months, we identify 180 eligible participants

180 study participants

Consenting and randomised participants n = 60

60 study participants

RTM treatment drop out ≤ 30%

TFCBT treatment drop out ≤ 50%

≥ 36 study participants

Research retention: 36 participants at 20 weeks

36 study participants

Outcome 2:

Quality of outcome data

Baseline data complete for 90% of participants

54 study participants

12-week data complete for 70% of participants

42 study participants

20-week data complete for 50% of participants

30 study participants

Outcome 3:

Known safety risks and ameliorations of RTM therapy

Adverse and serious adverse events and ameliorations recorded and discussed at the bi-weekly research team meeting

All 60 trial participants

A log of every adverse, serious adverse event and clinical and research team actions in response

All 60 trial participants

Outcome 4:

Establishment of expanded mental health care capacity in the veteran third sector

A minimum of 5 Inspire therapists will complete the 20-h training and be assessed as competent in delivering protocoled TFCBT

Ten Inspire therapists demonstrating competence in new therapeutic protocols and retained

A minimum of 5 different Inspire therapists will complete RTM training and be assessed as competent in delivering the RTM protocol

Therapists attend two–four weekly clinical supervision sessions

All therapists