A Multi-center Controlled Clinical Trial Of Simplified Cognitive Behavioral Therapy For Generalized Anxiety Disorder

Aims:To identify the applicability and efficacy of simplified cognitive behavior therapy(SCBT)for generalized anxiety disorder(GAD)via a multi-center controlled trial.Methods:1.Study design: An assessor-blinding multi-center controlled trial,in which participants were divided into three groups(SCBT group,medication group,SCBT plus medication group),was conducted.2.SCBT: During 8 weeks,twelve one-hour SCBT sessions were conducted two sessions per week in the first 4 weeks and one session per week in the last 4 weeks.3.Assessment: Assessment was performed at baseline and at 2,4,6,8,12,32 week after the initiation of treatments.4.Instruments: The Mini-International Neuropsychiatric Interview(MINI),7-item Generalized Anxiety Disorder Scale(GAD-7),the 9-item depression module from the Patient Health Questionnaire(PHQ-9),the Hamilton Anxiety Scale(HAMA),the Hamilton Depression Scale(HAMD),the short form 36 health survey questionnaire(SF36)and a self-devised questionnaire for therapists about the SCBT manual and a self-devised satisfactory questionnaire for SCBT patients were employed.5.Data management and analysis: Epidata version 3.1 was used to built the database with a double-entry manner.Via SPSS version 17.0,both full analysis sets and per protocol sets were employed in statistical analysis utilizing descriptive statistics,Chi-square test,one-factor ANOVA,repeated ANOVA,paired t-test etc.0.05 was chosen as the threshold of significant differences.Results:1.General information(1)From March 2014 to July 2015,359 patients were screened,154 were enrolled.112 patients finished 8-week treatment,among which 34 were treated with SCBT only,33 medication only,and 45 SCBT plus medication.108 patients finished 12-week follow-up,among which 34 were treated with SCBT only,29 medication only,and 45 SCBT plus medication.64 patients finished 32-week follow-up,among which 21 were treated with SCBT only,14 medication only,and 29 SCBT plus medication.134 patients were included in full analysis sets,among which 39 were treated with SCBT only,42 medication only,and 53 SCBT plus medication.(2)Between-group significant differences were not found in sex,personality type,education level,marriage status(P>0.05),while was found in age,stress(P<0.05).2.Primary outcome(cure rates at 8 week)Only SCBT group’s mean score of HAMA was under 7,between-group significant differences were found in cure rates(P=0.01).and its cure rate was significantly higher.3.Secondary outcome(1)Early response rate at 2 week(reductive rate ＞ 25%): for both GAD-7 and HAMA,no significant differences were found between groups(P=0.24,P=0.55).(2)Response rate at 8 week(reductive rate ＞ 50%): for GAD-7,no significant differences were found among groups(P=0.67);for HAMA,significant differences were found among groups(P=0.00).(3)Reductive rate: for GAD-7,mean reductive rate was above 50% in all three groups at 8,12 and 32 week,and no significant differences were found between groups at 8 and 32 week(P=0.57,P=0.32);significant differences were found between groups at 12 week(P=0.01);for HAMA,only medication group’s mean reductive rate was under 50%,and SCBT group’s reductive rate was significantly higher at 8,12 and 32 week(P=0.01,P=0.01,P=0.01).(4)Patients’ self-evaluation on treatment efficacy: no significant differences were found among groups(P>0.05).(5)Financial index:Only no significant differences were found among groups at 12 week(P>0.05).(6)quality of Life: at baseline,SCBT group’s social function score were significantly higher;no significant differences were found among groups in all domains at 8 week;between-group significant differences were found in general health and social function at 12 week(P=0.00,P=0.03);between-group significant differences were found in general health at 32 week(P=0.00).4.SCBT Applicability Most patients considered SCBT as a satisfactory therapy with high treatment efficacy by which they received the support they wanted and their problems were settled;most therapists considered SCBT to be a comprehensible therapy with operability and specific achievable goals.Conclusions:SCBT was applicable and therapeutic effect for GAD patients.