The Effectiveness of Group Behavioral Activation with Mindfulness in the Treatment of Subthreshold Depression in Primary Care in Hong Kong

研究背景：輕微抑鬱流行率高並且是重度抑鬱症的危險因素，會引起功能障礙、生活質素下降以及經濟負擔增加。研究目的：本研究包括四部分來探索行為激活與靜觀小組療法對輕微抑鬱的作用。初步可行性研究、隨機對照試驗、成本效用分析以及定性研究分別用來研究行為激活的可行性、有效性、成本效用及其有效成分。研究方法：在初步可行性研究中，由受訓過的健康相關醫務人員任導師，為十三位輕微抑鬱者提供為期八周的行為激活與靜觀療法，每週兩小時。干預內容主要包括活動規劃，目標設定以及靜觀練習。在隨機對照試驗中，採用1:1的比例將輕微抑鬱者隨機分配至行為激活組（n=115）和日常醫療組（n=116）。行為激活組接受行為激活與靜觀療法。除了日常醫療服務，對照組不接受額外心理干預。主要結局變量為貝克抑鬱量表第2版中文版測得的抑鬱症狀。其他次要結局變量包括生活質素、活動與環境變化程度、功能障礙程度以及焦慮症狀。分別在基線、干預後以及三個月隨訪時收集問卷。在成本效用分析中，質量調整生命年由欧洲五维健康量表測得，成本包括研究對象在研究期間所接受健康服務的花費以及八次行为激活治療的費用。我們界定增量成本效用比值低於50,000美元的優勢策略為“具有成本效益”。 為深入探索參加者主觀感受到治療的作用以及其中的有效成分，本研究開展了四個焦點小組訪談 （25人）。研究結果：初步課程可行性研究中的課程評價顯示參加者對治療滿意。保真度評估提示導師具備實施治療的能力。參加者建議減少靜觀部分的時間以及簡化家庭作業。隨機對照試驗結果表明，與對照組相比，干預組的抑鬱（F=14.544, P<0.001）及焦慮症狀（F=4.434, P=0.036）在干預後顯著下降。心理維度的生活質素（F=8.040, P=0.005）及活動及環境（F=11.992, P=0.001）在干預後均有顯著改善。隨訪三個月時，只有抑鬱症狀呈現出下降趨勢（F=3.479, P=0.064）。研究得出的增量成本效用比為29,211美元。當支付意願為50,000美元時，行為激活組比日常醫療組更具有成本效益的可能性為71.8%。決策制定者在衡量支付意願時，應當考慮到其中的不確定性。參加者認為行為激活治療對多個方面有效，例如情緒的改善、用新的視角和態度看待問題、學習解決問題的技能以及睡眠質素的提高。參加者最喜歡靜觀練習并認為其作用最為顯著。部分參加者認為活動規劃雖然有其作用，但保持練習存在一定的困難。研究結論：本研究表明行為激活及靜觀小組療法兼具可行性、短期有效性及成本效益，在未來更多研究的基礎上，可以考慮在基層醫療中將該療法作為一種應對輕微抑鬱的策略。Background: Subthreshold Depression (SD) is high prevalent and a risk indicator of major depressive disorder. It can cause functional impairment, decrease quality of life and increase economic cost.Objectives: We comprehensively explored the potential of group Behavioral Activation (BA) with mindfulness as the intervention for treating SD patients in primary care in Hong Kong by four studies: pilot study, randomized controlled trial, cost-utility analysis and qualitative study. These were to assess the feasibility, effectiveness, cost-effectiveness and useful components of the treatment respectively.Methods: In the pilot study, eight-week BA with mindfulness treatment (two hours per week) was provided to thirteen SD patients by trained allied healthcare workers. The treatment components included activity scheduling, goal setting and mindfulness practice. In the randomized controlled trial, 231 SD participants were recruited and randomly assigned to BA group (n=115) or Care as Usual (CAU) group (n=116). BA group was provided with BA and mindfulness treatment. CAU group could receive usual medical care but no additional mental interventions were provided for them. The primary outcome was reduction of depressive symptoms measured by BeckDepression Inventory (BDI)-II. The secondary outcomes included quality of life, activity and circumstances change, functional impairment and anxiety. Outcomes were assessed at baseline, post-intervention and 3-month follow-up period. In the cost-utility analysis, Quality-adjusted life-years were measured by EQ-5D and reported by the participants in each period. The cost was estimated from the societal perspective, including cost of healthcare utilization and eight training sessions. Four focus groups with 25 participants were conducted to find the useful components of the treatment in the perspective of the participants.Results: The treatment evaluation in the pilot study demonstrated that the participants were satisfied with the treatment. Fidelity assessment showed the instructors were competent in delivering the treatment. The participants suggested to reduce the time of mindfulness practice and to simplify the homework. In the randomized controlled trial, BA group demonstrated significant reduction of depressive symptoms (F=14.544, P