Table 4.

Ensemble risk reduction protocol schedule of assessments and procedures

Procedures/assessments	CRF (yes/no)	Staff member	Time (min)	−1	T0	First and second month	T1	T2
				Screening/ consent	Baseline/ randomisation	Ensemble versus support as usual	Post-test	Follow-up 4 months
Oral and written information	No	Research collaborator	20	√
Consent	No	Research collaborator	30	√
Eligibility criteria assessment	Yes	Research collaborator	10		√
Sociodemographic questionnaire	Yes	Assessor			√
The French Zarit Burden Interview	Yes	Assessor			√		√	√
Randomisation-computer generated	Yes	A specific randomisation coordinator	10		√
The Brief Symptom Inventory	Yes	Assessor			√		√	√
The Life Orientation Test-Revised	Yes	Assessor			√		√	√
The 36-item Medical Outcome Study Short-Form Health Survey	Yes	Assessor			√		√	√
The Social and Occupational Functioning Assessment Scale	Yes	Assessor			√			√
Qualitative data by 20 semi-directed interviews with participants in intervention	No	Two research collaborators						√
Treatment group	Yes	Intervention provider	360			√
All groups, being in touch and continuing information	No	Intervention provider	30			√
Supervision of intervention provider	No	Study coordinator	According to need	Continuously
Termination of the study		Study coordinator	According to need	Continuously
Serious adverse event form		Study coordinator	According to need	Continuously
Progress notes	No	All team members	According to need	Continuously