Nes Andréa Aparecida Gonçalves, van Dulmen Sandra, Brembo Espen Andreas, Eide Hilde
Faculty of Nursing, Lovisenberg Diaconal University College, Oslo, Norway.
Netherlands Institute for Health Services Research, Utrecht, Netherlands.
JMIR Mhealth Uhealth. 2018 Jul 3;6(7):e151. doi: 10.2196/mhealth.9942.
Web-based interventions are becoming an alternative of treatment aimed to support behavioral changes and several advantages over traditional treatments are reported. New ways of delivering an intervention may result in new challenges regarding monitoring of treatment fidelity (TF) which is essential to ensure internal and external validity. Despite the importance of the theme, only a few studies in this field are reported.
To examine TF of a mobile phone delivered intervention based on Acceptance and Commitment Therapy (ACT) with electronic diaries and written situational feedback for persons with diabetes mellitus type 2, the recommendations from the Behavior Change Consortium (BCC) established by The National Institutes of Health (NHI) were applied. To analyze fidelity, they recommend 5 areas to be investigated (1) design of the study, (2) provider training, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment. In the current study, these areas were examined based on the analysis of therapists' adherence to the treatment protocol and participants' and therapists' experience with the intervention.
To investigate the therapists' adherence to the treatment protocol, a total of 251 written feedback text messages were divided into text segments. Qualitative thematic analyses were then performed to examine how ACT and other therapeutic processes were used in the feedback by the therapists. For the therapists' and participants' experience analysis, participants answered a self-reported questionnaire and participated in 2 interviews. The therapists continuously reported their experiences to the researcher responsible for the project.
The results show high adherence to the TF strategies 20/21 (95%) applicable items of the fidelity checklist recommended by NHI BCC were identified in the present study. Measured provider skill acquisition post-training was the only item absent in the fidelity checklist. The results also show high therapists' adherence to the treatment protocol. All ACT processes (values, committed action, acceptance, contact with the present moment, self as context and cognitive defusion) were found in the coded text segments of the feedback in addition to communication and motivation strategies. For 336/730 (46%) of total possible text segments coded independently by 2 researchers, the interrater reliability measured by Cohen's kappa was .85. The evaluation of participants' and therapists' experience with the intervention was generally positive.
Based on the analyses of therapists' adherence to the treatment protocol grounded by ACT-principles and participants' and therapists' experience with the intervention, the 5 areas of TF recommended by NHI BCC were analyzed indicating a high level of TF. These results ensure an appropriate level of internal and external validity of the study and reliable intervention results and facilitate a precise replication of this intervention concept. Web-based psychological interventions to support people with chronic conditions are becoming increasingly more common. This study supports the results from a previous study which indicated that ACT could be reliably delivered in a written web-based format.
ClinicalTrials.gov NCT01297049; https://clinicaltrials.gov/ct2/show/NCT01297049 (Archived by WebCite at http://www.webcitation.org/70WC4Cm4T).
基于网络的干预正成为一种旨在支持行为改变的治疗替代方法，并且有报道称其具有优于传统治疗的若干优势。提供干预的新方式可能会给治疗保真度（TF）的监测带来新挑战，而治疗保真度对于确保内部和外部效度至关重要。尽管该主题很重要，但该领域仅有少数研究报道。
为了检验基于接受与承诺疗法（ACT）、配有电子日记及书面情境反馈的手机干预对2型糖尿病患者的治疗保真度，应用了美国国立卫生研究院（NHI）设立的行为改变联盟（BCC）的建议。为分析保真度，他们推荐调查5个领域：（1）研究设计，（2）提供者培训，（3）治疗实施，（4）治疗接受情况，（5）治疗执行情况。在本研究中，基于对治疗师遵循治疗方案情况以及参与者和治疗师对干预体验的分析来考察这些领域。
为调查治疗师对治疗方案的遵循情况，共251条书面反馈短信被分成若干文本片段。然后进行定性主题分析，以考察治疗师在反馈中如何运用ACT及其他治疗过程。对于治疗师和参与者的体验分析，参与者回答一份自我报告问卷并参加两次访谈。治疗师持续向负责该项目的研究人员汇报他们的体验。
结果显示对TF策略的高度遵循，本研究中识别出了NHI BCC推荐的保真度清单中20/21（95%）条适用项目。培训后测量的提供者技能习得是保真度清单中唯一缺失的项目。结果还显示治疗师对治疗方案的高度遵循。除沟通和动机策略外，在反馈的编码文本片段中还发现了所有ACT过程（价值观、承诺行动、接纳、接触当下、自我为背景和认知解离）。对于由2名研究人员独立编码的所有可能文本片段中的336/730（46%），通过科恩kappa系数测量的评分者间信度为0.85。对参与者和治疗师对干预体验的评价总体上是积极的。
基于对以ACT原则为基础的治疗师遵循治疗方案情况以及参与者和治疗师对干预体验的分析，对NHI BCC推荐的TF的5个领域进行了分析，表明TF水平较高。这些结果确保了研究具有适当水平的内部和外部效度以及可靠的干预结果，并有助于精确复制这一干预概念。基于网络的心理干预以支持慢性病患者正变得越来越普遍。本研究支持了先前一项研究的结果，该研究表明ACT可以以书面网络形式可靠地实施。
ClinicalTrials.gov NCT01297049；https://clinicaltrials.gov/ct2/show/NCT01297049（由WebCite存档于http://www.webcitation.org/70WC4Cm4T）
