Early Treatment For Generalized Anxiety Disorder Conducted By Chinese General Practitioners:a Randomized Clinical Trial.

Objective Most of the current researches reported efficacy of cognitive behavioral therapy(CBT) or pharmacological therapy(PT) for generalized anxiety disorder(GAD) conducted by professional psychologists or psychiatrists in psychiatric clinics. Therapies delivered by general practitioners are rare. The aim of our research is to examine effects of treatment conducted by general practitioners, to compare the efficacy of Health education, CBT and PT, and to explore the appropriate treatment strategies for GAD in primary care.Methods Randomized clinical trial included90adult patients from January2009to October2011in6primary care settings. Treatment was provided for12weeks; assessments were conducted at baseline, posttreatment(12weeks) and one follow-up(24weeks); during the12weeks treatment period, measures were assessed at2weeks intervals(with assessments at2,4,6,8, and10weeks). Patients randomized to health education group (n=23) received Anxiety Education Program. They were given a self-help anxiety managing booklet, and were telephoned biweekly by the same physician to remind them to use those anxiety managing strategies. Patients assigned to CBT group (n=22) received anxiety education and CBT; CBT involved cognitive therapy, relaxation exercise, and problem-solving practice. Patients assigned to pharmacological therapy (PT) group (n=22) received anxiety education and PT; PT included SSRI(paroxetine) combined with benzodiazepine (alprazolam) and sulpiride. Patients assigned to combination group (n=23) received a combination of anxiety education, CBT and PT. The primary outcome assessed anxiety severity with the Hamilton Anxiety Rating Scale (HAMA). Secondary outcomes included depressive symptoms(Zung Self-rating Depression Scale, SDS) and physical/mental health quality of life(the Medical Outcomes Study36-ltem Short-Form Health Survey, SF-36). Physical health(PH) quality of life included physical function, role physical, bodily pain and general health; Mental health(MH) quality of life included vitality, social function, role emotional and mental health.Results1.primary outcomes. Improvement on HAMA in participants of Combination group and Pharmacological therapy group were statistically greater than in those of Health education group. The average mean reduced at both posttreatment and follow-up(24weeks) in Pharmacological therapy group and Combination group compared with Health education group were4.32score and5.89score respectively. The differenced were both statistically significant(p<0.05). Although the mean score of CBT group was lower than that of Health education group, the difference was non-significant statistically.2. Secondary outcomes.(DImprovement on SF-36-PH in participants of Pharmacological therapy group and Combination group were statistically greater than in those of Health education group. The average mean increased at both posttreatment(12weeks) and follow-up(24weeks) in Pharmacological therapy group and Combination group compared with Health education group were9.63score and8.70score respectively. The differenced were both statistically significant(p<0.05). In addition, Improvement on SF-36-PH in participants of Pharmacological therapy group (P=0.014) and Combination group (P=0.020) were statistically greater than in those of CBT group.②Improvement differences on SF-36-MH between four groups were non-significant statistically.③Improvement on depression symptoms in patients of Combination group was greater than in those of Health education group, with a reduced mean score of7.72which is statistically significant(P=0.006).3. Improvement rate:a20%symptomatic improvement on the HAMA. The improvement rate of four groups were26.1%45.5%,59.1%and60.9%at2nd week, were56.5%,72.7%,72.7%and91.3%at posttreatment (12weeks), and were52.2%,81.8%,81.8%and95.7%at follow-up (24weeks) respectively.4. Response rate:a50%symptomatic improvement on the HAMA. The response rate of four groups were26.1%,40.9%,45.5%and65.2%at posttreatment (12weeks) respectively, and were30.4%,36.4%,50.0%and78.3%at follow-up (24weeks) respectively.5. Remission rate (HAMA score≤7). The remission rate of four groups were21.7%,31.8%,36.4%and47.8%at posttreatment (12weeks) respectively, and were30.4%,27.3%,36.4%and56.5%at follow-up (24weeks) respectively. Conclusions After a relatively simple training, therapies delivered by general practitioners were apparently helpful for patients with GAD. The treatment model in our study provided a lot of evidence for GAD intervention in primary care of China. However, larger sample size study is needed to confirm our conclusion.