Long-term Follow-up. 2006 Regional Collaboratives
Long-term Follow-up. All subjects will be evaluated for long-term effects 12 months (within a visit window of +/- 1 month) after their last MDMA-assisted psychotherapy session. This visit will consist of two meetings, one with the IR and the other with the therapists. Subjects who have withdrawn from treatment but have continued for follow up will also complete this time point. At the Long-term Follow-up visit:
a. The IR will administer the CAPS, PDS, BDI-II, GAF and the PSQI.
b. Subjects will have a final meeting with at least one of the therapists to review specified AEs and medications since the last visit. Subjects should bring the Memory Aid Cards to this visit, to be used as aids in recollection. These cards will not be collected. AEs and Medications will be collected as described in Sections 8.5 and 9.0 of the protocol.
c. The therapists will assess suicidality with the C-SSRS.
d. General wellbeing will be assessed.
e. Subjects will complete a questionnaire assessing positive and negative long-term effects of the study.
f. Subjects will complete the termination visit at this time.
Long-term Follow-up. All subjects will be evaluated for long-term effects 12 months (within a visit window of plus or minus one month) after their last MDMA-assisted psychotherapy session. This visit will consist of two meetings, one with the Independent Rater and the other with the therapists. Subjects who have withdrawn from treatment but have continued for follow- up will also complete this time point. This visit may be audio and video recorded. At the Long-term Follow-up visit:
a. The Independent Rater will administer the CAPS and GAF.
b. Subjects will complete the PDS, BDI-II, NEO-PI, PSQI, PTGI (in reference to start of the study), and DES-II.
c. Subjects will have a final meeting with at least one of the therapists to review specified AEs and medications since the last visit. Subjects should bring the Memory Aid Cards to this visit, to be used as aids in recollection. These cards will not be collected. AEs and Medications will be collected as described in Section 14.0 of the protocol.
d. The therapists will assess suicidality with the C-SSRS.
e. Subjects will complete a questionnaire assessing positive and negative long-term effects of the study.
f. A researcher who is a part of the study team may ask the subject questions about positive or negative effects about the study in person or on the phone.
g. The visual analog scale will be used to collect changes in pre-existing tinnitus and chronic pain symptoms.
h. Subjects will complete the termination visit at this time.
Long-term Follow-up. Long term follow-up is carried out and the AHCH post BMT clinic and referral to appropriate adult services happens at age 18. HEALTH & SAFETY The responsibility for all who work on the premises, including the use of equipment, lies with the organization that has control of the premises. The responsible organization will comply with its Health and Safety Policy, including Lone Working and Out of Hours Working Policies where relevant, and will ensure there are mechanisms in place to prevent and address any health and safety issues as defined under the Health and Safety at Work Act (1974). It is the responsibility of both Trusts’ employees attending remote premises to ensure they personally comply with the Health and Safety Policy of the remote organisation.
