Development of a Guided Self-help Mobile App to Improve Treatment Outcome for Individuals Suffering From Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Change from baseline in Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM):
研究概览
简要总结
Eating disorders (EDs) are psychiatric illnesses characterised by pathological eating behaviours, ranging from protracted undereating to recurrent loss of control over eating. Based on the transdiagnostic approach, EDs are triggered and maintained by interpersonal distress and difficulties to manage negative emotions. Thus, interpersonal skills have been implicated as important targets for change in the treatment. In this project, we will adopt digital technologies to improve treatment adherence and outcome of individuals with EDs, by testing the effectiveness of an online self-help program delivered through a mobile app. Specifically, this project aims to establish if an online personalized self-help approach is feasible and effective in ameliorating eating disorder symptoms and distress. We planned to conduct two randomised controlled trials to test the effectiveness of online guided self-help (GSH) in two different settings: (1) the community, and (2) the outpatient setting. This is to establish at which stage of treatment this approach is most helpful. Across studies, we will recruit 242 individuals aged ≥18 years with ED symptoms and/or a proper diagnosis of EDs (DSM-5). During eight weeks period, GSH will be available to participants both on a website and a new-developed smartphone app and consists of written materials and brief video-clips, a weekly chat based forum group and an online interpersonal group session. Guidance in forum groups will be facilitated by non-specialist help-care providers (i.e., peer mentors); whereas experienced mental health providers will lead the online group sessions. Participant's interpersonal distress will be assessed at intake to personalize guidance in the group, by addressing dysfunctional interpersonal characteristics which can be associated with ED symptoms. Participants will also complete a weekly working alliance measure to examine whether the quality of relationship with mentor predicts clients' level of clinical change.
Regarding the outpatient setting, the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis: 1) overall psychological distress. In the community setting, the study aims to examine if GSH is effective to improve the following primary outcomes for individuals with self-reported ED symptoms: 1) overall psychological distress; 2) first contact with clinical services to manage their dysfunctional eating behaviors.
详细描述
Despite the disabling nature of eating disorders, many individuals with EDs do not receive appropriate mental health care. Recently, the use of eHealth technology has been proposed as a potentially effective alternative to traditional, inperson treatment delivery for those with EDs. Specifically, self-help programs include the use of materials, such as books, workbooks and videoclips, to empower patients through information and skills to cope with the illness. Guided self-help adds the element of guidance to the use of these materials.
The project aims to exploit the use of highly scalable and inclusive digital technologies (i.e., mobile app and online GSH) to improve the transdiagnostic understanding of EDs and their psychological treatment. Online GSH will be developed based on pre-existing UK-based model of intervention (RecoveryMANTRA and ECHOMANTRA) and will be adapted to Italian young adults through the introduction of a smartphone app aimed to monitor and support individuals to treatment. This project aims to establish at what stage of illness the evidence-based interventions used are most valued and beneficial to individuals. Therefore, online GSH will be tested in two different settings and clinical context: (1) the outpatient setting for those reporting a diagnosis of ED; and (2) the community setting for people reporting symptoms of eating disorders who are not receiving psychological treatment. GSH translated for delivery through smartphone app may be one solution towards reducing treatment gap for people with ED who do not still receive a proper support, fostering awareness and motivation to start treatment as well as an augmenting strategy to improve clinical outcomes for patients undergoing routine treatment delivered by clinical services.
Primary aims: Regarding the outpatient setting, the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis: 1) overall psychological distress. Secondary outcomes are: 1) eating disorder psychopathology; 2) interpersonal distress; 3) quality of life; 4) motivation for treatment; 5) emotion dysregulation; 6) Body Mass Index, 7) satisfaction with treatment, at the end of the 8-week intervention and 3-month follow-up compared to the control condition.
In the community setting, the study aims to examine if GSH is effective to improve the following primary outcome for individuals with symptoms of disordered eating: 1) overall psychological distress; Secondary outcomes are: 1) eating disorder psychopathology; 2) interpersonal distress; 3) quality of life; 4) motivation for treatment; 5) emotion dysregulation, 6) Body Mass Index, 7) satisfaction with treatment, 8) first contact with clinical services to manage their dysfunctional eating behaviors, at the end of the 8-week GSH and at 3-month follow-up compared to the control condition. Secondary aims: A secondary aim is to determine the extent to which the working alliance with clinicians delivering weekly online group guidance is associated with clients' clinical changes on a session-by-session basis during the intervention. Given the difficult nature of building a strong therapeutic alliance with ED patients (Warren, Crowley, Olivardia & Schoen, 2008), an increased willingness to trust in clinician during the online GSH may be a basis for increased treatment involvement and symptomatic improvement.
Study 1. The first study is a multicentric RCT where participants with a proper diagnosis of eating disorders will be recruited at the Eating Disorders Unit of the University Hospital of Catanzaro and Padova. The aim of this RCT is to answer to the question: "Does online guided self-help through mobile app for eating disorders provided in addition to TAU improve overall psychological distress, eating disorder psychopathology, BMI, interpersonal distress, quality of life, motivation for treatment, emotion dysregulation, satisfaction with treatment compared to treatment as usual alone (outpatient treatment) among young people with a diagnosis of eating disorders?".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for study 1 are: (1) >18 years, (2) with a clinician-formulated diagnosis of eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or Other Specified Feeding or Eating Disorder based on the criteria of the DSM-5-TR, (3) having started TAU within 12 months; (4) with access to Internet connection through a mobile device, (5) Italian speaking.
- •The inclusion criteria for study 2 are: (1) >18 years, (2) a score > 2.77 on the Eating Disorders Examination Questionnaire, (3) attending no treatment for eating disorder symptoms but reporting a regular monitoring by their own primary care physician (GP), 4) with access to Internet connection through a mobile device, (4) Italian speaking.
排除标准
- •For both study 1and 2: acute psychosis, clinical depression or suicidal ideation, pregnancy, use of medication that might influence eating behavior, neurological and visual impairment and Intellectual disability.
研究组 & 干预措施
Treatment-as-usual
Treatment as usual will vary between centres and this will impact the effect size of the intervention (Ayling et al., 2015). We will therefore conduct structured interviews with clinicians at each study site to clarify the nature of treatment as usual at each centre. We will also use an adapted form of the Client Service Receipt Inventory (a well-established tool used in health economics) to track the amount of treatment received over the year (Beecham & Knapp, 1992). The inventory will be administered at 8-week and 3-month, to measure patients' service usage.
干预措施: TAU (Behavioral)
结局指标
主要结局
Change from baseline in Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM):
时间窗: Baseline, end-of-treatment (8 weeks), and 3-month follow-up.
The CORE-OM is a 34-item validate, self-report scale (of which 25% are reverse items) assessing global distress of the subject across 4 domains: \[Well-being (4 items); Functioning (12 items); Problems/symptoms (12 items); Risk (to self and to others) (6 items)\] over the last week. Items are answered on the same five-point scale (0-4) ranging from 'not at all' to 'most or all the time'. Overall, the measure is problem scored (i.e. higher scores indicate more problems). Scores are reported as means across items that give a 'pro-rated' score if there are incomplete responses.
次要结局
- Change from baseline in the Autonomous and Controlled Motivation for Treatment Questionnaire(Baseline, 8 weeks, and 3-month follow-up.)
- Change from baseline in the Inventory of Interpersonal Problems(Baseline, 8 weeks, and 3-month follow-up.)
- Change from baseline in the Eating Disorder Examination Questionnaire(Baseline, 8 weeks, and 3-month follow-up.)
- Change from baseline in the Difficulties in Emotion Regulation Scale(Baseline, 8 weeks, and 3-month follow-up.)
- Change from baseline in the Client Satisfaction Questionnaire(Baseline, 8 weeks, and 3-month follow-up.)
研究者
Gianluca Lo Coco
Professor
University of Palermo