This was an open-label, black-box, before-and-after study design with no control group; every participant received OMTh. The clinicians (M.A.K. and L.D.) were not blinded. Participants were administered outcome measures at screening (visit 1), baseline (visit 2), and follow-up visits (visits 3-7). The secondary efficacy end points were the mean changes from before to after OMTh on the BAI
37 and the IUS.
38 Participants were assessed at the initial screening visit using the Mini International Neuropsychiatric Interview (MINI) 6.0.0
34 to screen for a primary diagnosis of GAD and to rule out other primary mood and anxiety disorders. At screening, participants were further assessed using the physician-administered Hamilton Anxiety Rating Scale (HAM-A)
35 and Hamilton Depression Rating Scale (HAM-D).
36 The treating psychiatrist (M.A.K.) conducted all assessments and the screening visit (visit 1), which included a brief medical and physical examination. Participants were also given a package of self-reported questionnaires
37,38 to confirm safety and acceptability. Each participant received 5 sessions of OMTh during the period of 8 to 9 weeks. Visit 2 was scheduled for 1 week after the initial screening visit and was the baseline OMTh assessment. Visits 2, 3, and 4 (the first, second, and third OMTh appointments) were scheduled weekly, plus or minus 3 days to accommodate scheduling conflicts. Visits 5 and 6 (the fourth and fifth OMTh appointments) were scheduled to occur biweekly, plus or minus 3 days. Reassessment of the primary and secondary measures took place immediately before each OMTh appointment. At visit 7, scheduled 1 week after visit 6 (plus or minus 3 days) the psychological assessments were readministered.
A foreign-trained osteopath (L.D.) performed the OMTh. The psychiatrist (M.A.K.) administered the MINI, the HAM-A, and the HAM-D, as well as the brief medical and physical examinations. Two self-reported questionnaires (Beck Advisory Index [BAI] and Intolerance of Uncertainty Scale [IUS]) were used as secondary outcome measures, distributed to participants, and later collected by clinic research associates.
Participants were administered outcome measures at screening (visit 1), baseline (visit 2), and follow-up visits (visits 3-7). The primary efficacy end point was the mean change from before to after OMTh on the HAM-A.
35 The secondary efficacy end points were the mean changes from before to after OMTh in the BAI
37 and the IUS.
38