Cano-Vindel Antonio, Muñoz-Navarro Roger, Moriana Juan A, Ruiz-Rodríguez Paloma, Medrano Leonardo Adrián, González-Blanch César
Faculty of Psychology, Complutense University of Madrid, Campus de Somosaguas, s/n, 28223Madrid, Spain.
Department of Psychology and Sociology, Faculty of Social and Human Sciences, University of Zaragoza, C/Cdad. Escolar, S/N, 44003, Teruel, Spain.
Psychol Med. 2021 Feb 8;52(15):1-13. doi: 10.1017/S0033291720005498.
Emotional disorders are highly prevalent in primary care. We aimed to determine whether a transdiagnostic psychological therapy plus treatment-as-usual (TAU) is more efficacious than TAU alone in primary care adult patients.
A randomized, two-arm, single-blind clinical trial was conducted in 22 primary care centres in Spain. A total of 1061 adult patients with emotional disorders were enrolled. The transdiagnostic protocol (n = 527) consisted of seven 90-min sessions (8-10 patients) delivered over a 12-14-week period. TAU (n = 534) consisted of regular consultations with a general practitioner. Primary outcome measures were self-reported symptoms of anxiety, depression, and somatizations. Secondary outcome measures were functioning and quality of life. Patients were assessed at baseline, post-treatment, and at 3, 6, and 12 months. Intention-to-treat and per-protocol analyses were performed.
Post-treatment primary outcomes were significantly better in the transdiagnostic group compared to TAU (anxiety: p < 0.001; Morris's d = -0.65; depression: p < 0.001; d = -0.58, and somatic symptoms: p < 0.001; d = -0.40). These effects were sustained at the 12-month follow-up (anxiety: p < 0.001; d = -0.44; depression: p < 0.001; d = -0.36 and somatic symptoms: p < 0.001; d = -0.32). The transdiagnostic group also had significantly better outcomes on functioning (d = 0.16-0.33) and quality of life domains (d = 0.24-0.42), with sustained improvement at the 12-month follow-up in functioning (d = 0.25-0.39) and quality of life (d = 0.58-0.72). Reliable recovery rates showed large between-group effect sizes (d > 0.80) in favour of the transdiagnostic group after treatment and at the 12-month follow-up.
Adding a brief transdiagnostic psychological intervention to TAU may significantly improve outcomes in emotional disorders treated in primary care.
isrctn.org identifier: ISRCTN58437086.
情绪障碍在初级保健中极为普遍。我们旨在确定一种跨诊断心理治疗加常规治疗(TAU)在初级保健成年患者中是否比单纯TAU更有效。
在西班牙的22个初级保健中心进行了一项随机、双臂、单盲临床试验。共纳入1061名患有情绪障碍的成年患者。跨诊断方案(n = 527)包括在12 - 14周内进行七次90分钟的治疗(每次8 - 10名患者)。TAU组(n = 534)包括与全科医生的定期会诊。主要结局指标为自我报告的焦虑、抑郁和躯体化症状。次要结局指标为功能状态和生活质量。在基线、治疗后以及3、6和12个月时对患者进行评估。进行了意向性分析和符合方案分析。
与TAU组相比,跨诊断组治疗后的主要结局显著更好(焦虑:p < 0.001;莫里斯效应量d = -0.65;抑郁:p < 0.001;d = -0.58;躯体症状:p < 0.001;d = -0.40)。这些效果在12个月随访时仍持续存在(焦虑:p < 0.001;d = -0.44;抑郁:p < 小.001;d = -0.36;躯体症状:p < 0.001;d = -0.32)。跨诊断组在功能状态(d = 0.16 - 0.33)和生活质量领域(d = 0.24 - 0.42)也有显著更好的结局,在12个月随访时功能状态(d = 0.25 - 0.39)和生活质量(d = 0.58 - 0.72)持续改善。可靠的康复率显示,治疗后及12个月随访时,两组间效应量差异大(d > 0.80),支持跨诊断组。
在TAU基础上增加简短的跨诊断心理干预可能显著改善初级保健中治疗的情绪障碍的结局。
isrctn.org标识符:ISRCTN58437086。