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Table 2 Group processes and response to adverse events used in the trial

From: The MATISSE study: a randomised trial of group art therapy for people with schizophrenia

Aspect of structure or content of groups

Aspects shared by Art Therapy and activity groups

Engaging with the group

Group facilitators should contact new members by post and or telephone to invite them to the group and provide them with details of location, start times etc. Facilitators should try to meet participants on one occasion before they commence the group to outline aims, protocol boundaries and expectations. This may be done either individually or in groups

Group member leaves the group

When a group member specifically tells the facilitator that that they do not want to attend the group, or when they have not attended the group for a number of weeks without there being a clear reason for the facilitator should use their clinical judgement to make a decision about when they should be considered as having left the group. At this stage the facilitator will write to the patient confirming that their place in the group has closed

Replacing a group member with another patient

When it is agreed that a patient has left the group the facilitator should notify the trial coordinator who will make a note that there is a space in the group that can be filled by another study participant

Verbal aggression or violence

Facilitator to obtain and refer to risk assessment for all group members prior to their joining. In case of agitation/aggression/violence, the facilitator should use their clinical judgement to assess the situation and attempt de-escalation. The group member may need to be asked to leave the room. Inform the patient's care-coordinator, document the incident on the treatment fidelity proforma and complete incident form etc (as per usual clinical practice). Patients may be asked to stay away from subsequent groups (such a decision should be discussed with clinical supervisor)

Deteriorating mental state

Where a participant's mental state shows clear signs of deteriorating the facilitator should encourage the patient to discuss this with their care coordinator or psychiatrist. If the situation continues to deteriorate the facilitator should seek verbal consent from the patient to contact their care coordinator. In consultation with their supervisor and following review of their risk assessment and care plan, there may be circumstances in which the facilitator will need to contact the patient's care coordinator even if consent is withheld

Therapist leaves local services OR sick leave etc

When long gaps look likely the situation should be discussed with the local supervisor and efforts made to identify a new facilitator. Participants should be given as much notice of this as possible