Enander Jesper, Andersson Erik, Mataix-Cols David, Lichtenstein Linn, Alström Katarina, Andersson Gerhard, Ljótsson Brjánn, Rück Christian
Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden
Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.
BMJ. 2016 Feb 2;352:i241. doi: 10.1136/bmj.i241.
To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy.
A 12 week single blind parallel group randomised controlled trial.
Academic medical centre.
94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial.
Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks.
The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial.
BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high.
CBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide.Trial registration ClinicalTrials.gov ID: NCT02010619.
评估治疗师指导的基于互联网的身体变形障碍认知行为疗法(BDD-NET)与在线支持性疗法相比的疗效。
一项为期12周的单盲平行组随机对照试验。
学术医疗中心。
94名自我转诊的成年门诊患者,诊断为身体变形障碍,改良耶鲁-布朗强迫症量表(BDD-YBOCS)评分≥20。如果在入组前剂量已稳定至少两个月且在试验期间保持不变,则允许同时进行精神药物治疗。
参与者接受通过互联网提供的BDD-NET(n = 47)或支持性疗法(n = 47),为期12周。
主要结局是由一名盲态评估者评估的治疗后及随访(基线后3个月和6个月)时的BDD-YBOCS评分。反应者状态定义为量表上症状减轻≥30%。次要结局是抑郁(MADRS-S)、整体功能(GAF)、临床总体改善(CGI-I)和生活质量(EQ5D)的测量指标。由于行政失误,6个月的随访时间以及3个月时除BDD-YBOCS和MADRS-S之外的所有结局在ClinicalTrials.gov注册时未预先指定,但包含在试验开始前经地区伦理委员会批准的原始试验方案中。
BDD-NET优于支持性疗法,且与身体变形障碍症状严重程度(BDD-YBOCS组间差异-7.1分,95%置信区间-9.8至-4.4)、抑郁(MADRS-S组间差异-4.5分,-7.5至-1.4)及其他次要指标的显著改善相关。在随访时,接受BDD-NET治疗的患者中有56%被归类为反应者,而接受支持性疗法的为13%。治疗所需人数为2.34(1.71至4.35)。自我报告的满意度较高。
认知行为疗法可通过互联网安全地提供给身体变形障碍患者。BDD-NET有潜力增加对这种精神障碍基于证据的精神科护理的可及性,符合英国国家卫生与临床优化研究所的优先推荐。在阶梯式护理方法中可能特别有用,其中全科医生或其他心理健康专业人员可为自杀风险低的轻至中度症状患者提供治疗。试验注册ClinicalTrials.gov标识符:NCT02010619。