Schwarz Rasmus, Miskowiak Kamilla Woznica, Christensen Mie Skovmand, Kessing Lars Vedel, Vinberg Maj
Mental Health Centre, The Early Multimodular Prevention and Intervention Research Institution (EMPIRI), Hillerød, Denmark.
Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, Denmark.
Psychol Med. 2024 Oct 31;54(14):1-10. doi: 10.1017/S0033291724002526.
There is a compelling need for innovative intervention strategies for patients with affective disorders, given their increasing global prevalence and significant associated disability and impaired functioning. This study aimed to investigate whether a comprehensive multimodule individualized intervention (AWARE), targeting known mediators of functioning, improves functioning in affective disorders.
AWARE was a randomized, controlled, rater-blind clinical trial conducted at two centers in the Capital Region of Denmark (Clinicaltrials.gov, NCT04701827). Participants were adults with bipolar disorder or major depressive disorder and impaired functioning. Participants were randomized to the six-month AWARE intervention or treatment as usual (TAU). The AWARE intervention is based on the International Classification of Functioning, Disability and Health (ICF) Brief Core Set for Bipolar and Unipolar Disorder.The primary outcome was observation-based functioning using the Assessment of Motor and Process Skills (AMPS). Secondary outcomes were functioning, QoL, stress, and cognition.
Between February 2021 and January 2023, 103 patients were enrolled; 50 allocated to AWARE treatment and 53 to TAU (96 included in the full analysis set). There was no statistically significant differential change over time between groups in the primary outcome (AMPS), however, both groups showed a statistically significant improvement at endpoint. The AWARE intervention had a statistically significant effect compared with TAU on secondary outcomes of patient-reported functioning, stress and cognition.
Compared with TAU, the AWARE intervention was ineffective at improving overall functioning on the primary outcome, presumably due to the short duration of the intervention. Further development of effective treatments targeting functioning is needed.
鉴于情感障碍患者在全球的患病率不断上升，且伴有严重的相关残疾和功能受损，迫切需要创新的干预策略。本研究旨在调查针对已知功能调节因子的综合多模块个体化干预（AWARE）是否能改善情感障碍患者的功能。
AWARE是一项在丹麦首都地区的两个中心进行的随机、对照、评估者盲法临床试验（Clinicaltrials.gov，NCT04701827）。参与者为患有双相情感障碍或重度抑郁症且功能受损的成年人。参与者被随机分配接受为期六个月的AWARE干预或常规治疗（TAU）。AWARE干预基于双相和单相情感障碍的《国际功能、残疾和健康分类》（ICF）简要核心集。主要结局是使用运动和过程技能评估（AMPS）基于观察的功能。次要结局包括功能、生活质量、压力和认知。
在2021年2月至2023年1月期间，共招募了103名患者；50名被分配接受AWARE治疗，53名接受TAU治疗（96名纳入全分析集）。两组在主要结局（AMPS）上随时间的变化没有统计学上的显著差异，然而，两组在终点时均显示出统计学上的显著改善。与TAU相比，AWARE干预在患者报告的功能、压力和认知等次要结局上有统计学上的显著效果。
与TAU相比，AWARE干预在改善主要结局的整体功能方面无效，可能是由于干预时间较短。需要进一步开发针对功能的有效治疗方法。
