Braun Moritz Nicolai, Michael Tanja, Equit Monika, Lass-Hennemann Johanna
Department of Psychology, Saarland University, Saarbrücken, Germany
Department of Psychology, Saarland University, Saarbrücken, Germany.
BMJ Open. 2025 Jul 15;15(7):e101648. doi: 10.1136/bmjopen-2025-101648.
INTRODUCTION: Exposure is a central component in the treatment of a range of mental disorders. However, despite high efficacy and efficiency, dissemination of exposure-based treatments is limited. Important factors that contribute to this limited dissemination are negative beliefs about exposure on the part of the public, the therapists, and the patients. While patients perceive exposure therapy as burdensome, therapists are concerned about putting too much strain on their patients during exposure, leading to suboptimal delivery of exposure. In a previous study, in which healthy participants underwent a differential fear conditioning paradigm, we found initial evidence that the integration of a therapy dog into exposure reduces participants' anxiety and increases participants' positive affect without causing poor treatment outcome. Thus, the integration of a therapy dog into exposure might be a promising approach to address patients' and therapists' concerns and, thus, to (1) foster dissemination of exposure that is (2) delivered in an optimal manner. To scrutinise our findings in a clinical sample, we designed the present study. We test the following hypotheses: (H1) participants in the dog group report significantly less anxiety during the course of the treatment than participants in the control group. (H2) Participants in the dog group report significantly more positive affect during the course of the treatment than participants in the control group. (H3) Participants in the dog group report significantly higher therapy motivation than participants in the control group. (H4) Participants in the dog group report significantly lower anticipatory anxiety than participants in the control group. (H5) The treatment in the dog group is not inferior to the treatment in the control group. METHODS AND ANALYSIS: In this parallel randomised controlled trial of two groups, =88 participants (spider phobics without: a current diagnosis of a mental disorder other than a specific phobia, insect bite allergy, dog hair allergy, fear of dogs, current psychopharmacological treatment, and current psychotherapeutic treatment; the sample size calculation is based on the results from our previous study) are randomly allocated (with a 1:1 allocation as per a computer-generated randomisation schedule) to either an ambulant one-session in vivo exposure treatment of spider phobia with a therapy dog (dog group) or without a dog (control group). Due to the nature of the intervention, neither participants nor therapists can be blinded once participants are allocated to one of the two groups. However, the person conducting screening and diagnostics is blind to the allocation, participants are blind to the hypotheses and the respective other group, and the researchers are blind to the allocation while analysing the data. We will test (H1) and (H2), concerned with our primary outcomes, by means of 2×4 mixed analyses of variance with the between-subjects factor group (dog group vs. control group), the within-subjects factor time (with four levels, one for each time point anxiety and affect are measured during treatment), and anxiety or positive affect as the dependent variable, respectively. We will test (H3) and (H4) by means of an analyses of covariance with therapy motivation/anticipatory anxiety at baseline as the covariate, the between-subjects factor group (dog group vs. control group) and therapy motivation/anticipatory anxiety at pre-treatment as the dependent variable, respectively. We will test (H5) by means of 95% CIs and non-inferiority zones. ETHICS AND DISSEMINATION: This trial was approved by our university's ethics committee (reference number 24-11). Any deviations from this study protocol or the preregistrations as well as any adverse events potentially arising in the course of the trial, will be made explicit in the publication of the trial results. All participants provided written informed consent prior to the inclusion into the trial. The findings from this trial will be disseminated by means of common academic pathways, including peer-reviewed publications and conference presentations. Following common open science practices, data and analysis code will also be made publicly available in anonymised form on the Open Science Framework (osf.io). TRIAL REGISTRATION NUMBER: On 18 June 2024, this study was registered at the German Clinical Trials Register (ID: DRKS00034494; https://drks.de/search/de/trial/DRKS00034494) and preregistered at AsPredicted (https://aspredicted.org/JRP_SCF).
引言:暴露疗法是治疗一系列精神障碍的核心组成部分。然而,尽管其疗效显著且效率高,但基于暴露的治疗方法的传播却很有限。导致这种有限传播的重要因素包括公众、治疗师和患者对暴露疗法的负面看法。患者认为暴露疗法很繁重,而治疗师则担心在暴露过程中给患者带来过大压力,从而导致暴露疗法的实施效果欠佳。在之前一项让健康参与者接受差异恐惧条件范式的研究中,我们初步发现,将治疗犬融入暴露疗法可减轻参与者的焦虑并增强其积极情绪,且不会导致治疗效果不佳。因此,将治疗犬融入暴露疗法可能是一种很有前景的方法,可解决患者和治疗师的担忧,进而(1)促进以最佳方式实施的暴露疗法的传播。为了在临床样本中验证我们的研究结果,我们设计了本研究。我们检验以下假设:(H1)与对照组参与者相比,犬组参与者在治疗过程中报告的焦虑显著更少。(H2)与对照组参与者相比,犬组参与者在治疗过程中报告的积极情绪显著更多。(H3)与对照组参与者相比,犬组参与者报告的治疗动机显著更高。(H4)与对照组参与者相比,犬组参与者报告的预期焦虑显著更低。(H5)犬组的治疗效果不低于对照组的治疗效果。 方法与分析:在这项两组平行随机对照试验中,88名参与者(蜘蛛恐惧症患者,排除:目前诊断患有除特定恐惧症以外的精神障碍、昆虫叮咬过敏、犬毛过敏、怕狗、目前正在接受心理药物治疗和目前正在接受心理治疗;样本量计算基于我们之前研究的结果)被随机分配(根据计算机生成的随机分配表按1:1分配)至接受治疗犬辅助的门诊单次现场暴露治疗蜘蛛恐惧症组(犬组)或无治疗犬组(对照组)。由于干预措施的性质,一旦参与者被分配到两组之一,参与者和治疗师都无法设盲。然而,进行筛查和诊断的人员对分配情况不知情,参与者对假设和各自所在的另一组不知情,研究人员在分析数据时对分配情况不知情。我们将通过2×4混合方差分析来检验与我们主要结局相关的(H1)和(H2),其中组间因素为组(犬组与对照组),组内因素为时间(有四个水平,分别对应治疗期间测量焦虑和情绪的每个时间点),因变量分别为焦虑或积极情绪。我们将通过协方差分析来检验(H3)和(H4),以基线时的治疗动机/预期焦虑作为协变量,组间因素为组(犬组与对照组),因变量分别为治疗前的治疗动机/预期焦虑。我们将通过95%置信区间和非劣效性区间来检验(H5)。 伦理与传播:本试验已获得我校伦理委员会批准(参考编号24 - 11)。本试验结果发表时,将明确说明与本研究方案或预先注册的任何偏差以及试验过程中可能出现的任何不良事件。所有参与者在纳入试验前均提供了书面知情同意书。本试验的结果将通过常见的学术途径进行传播,包括同行评审出版物和会议报告。遵循常见的开放科学实践,数据和分析代码也将以匿名形式在开放科学框架(osf.io)上公开提供。 试验注册号:2024年6月18日,本研究在德国临床试验注册中心注册(ID:DRKS00034494;https://drks.de/search/de/trial/DRKS00034494),并在AsPredicted(https://aspredicted.org/JRP_SCF)上进行了预先注册。
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