Is the Betwixt Application Effective and Acceptable in Improving Emotion Regulation for an Adult Clinical Population?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
研究概览
简要总结
Title Is the Betwixt application effective and acceptable in improving emotion regulation for an adult clinical population? Short title Betwixt: Effective/acceptable clinical population emotion regulation? Chief Investigator Jacob Andrews Aims A: Evaluate the effectiveness of the Betwixt intervention on emotion regulation, self-compassion, and cognitive reappraisal in a clinical population.
B: Investigate whether changes in processes targeted by Betwixt result in improvements in clinical outcomes.
C: Explore the acceptability, and putative processes of Betwixt within a clinical context.
Trial configuration Single Case Experimental Design (SCED) series and acceptability and change interviews Setting Lincolnshire Partnership Foundation Trust Sample size estimate Minimum of three cases recommended Number of participants Eight (with replacement participants if they do not contribute sufficient data to the intervention phase) Eligibility criteria Inclusion criteria for IAPT services: Adult, on the waiting list for the service, experiencing an anxiety disorder or depression, own a mobile phone, and comfortable using a phone for an extended period. Able to give informed consent.
Exclusion criteria: Insufficient English reading ability and not available for the length of the intervention.
Description of interventions The intervention is an interactive game called Betwixt, which is delivered to participants via an app. Betwixt is a theory-driven app with foundations in emotion regulation, cognitive behavioural therapy, and mindfulness. Each participant will have access to the app for four weeks and will be asked to use it every two days.
Duration of study Overall: 24 months Per participant: Seven weeks Outcome measures CER-Q, DERS-SF, GAD-2, GAD-7, PHQ-2, PHQ-9, SCS, SWEMWBS and WSAS Analytical methods Structured visual analysis; Kendall's Tau-U; Reliable Change and Clinically Significant Change analysis; Simulation Modelling Analysis; and Framework Analysis.
详细描述
Study Background Information and Rationale Mental health problems are one of the main causes of overall disease burden globally (7.4%) (more than HIV/AIDs and tuberculosis, diabetes, and transport injuries), and their prevalence continues to rise. Globally, 792 million people (10.7%) experience mental health problems, and anxiety is the most prevalent (284 million/3.8%), followed by depression (264 million/3.4%). One in six adults in England have a common mental disorder (depression or anxiety), which is approximately one woman in five or one man in eight. Hence, mental health problems have a significant public health impact, nationally and globally.
National Context Within the UK, the NHS Long Term Plan (NHSLTP) outlined a new service model to overcome concerns of funding, staffing, increased inequalities, and pressures, by providing more options, better support, and coordinated care at the right time, in the optimal setting. The associated Mental Health Implementation Plan (NHSMHIP) outlined the priorities of the NHSLTP in mental health, including digitally enabled mental health care. This involved NHS England and NHS Improvement supporting the development of applications ("apps"), digitally enabled models of therapy, and online resources to support mental health and recovery. Digital mental health interventions have been found to be effective and acceptable means of delivering mental health support on a large scale.
The NHS previously had a library of approved apps which closed in 2021 and now they only recommend the NHS app and the COVID-19 app. As a result, NHS England created the Digital Technology Assessment Criteria for Health and Social Care, an assessment tool for ensuring digital health technologies meet standards of legislation and good practice. There is currently no database of recommended apps and there is an onus on healthcare organisations to assess each app at the point of procurement. The Mental Health Million project surveyed over 45,000 respondents and found that 50% of individuals with a clinical level of mental health risk did not seek help. The reasons were not knowing what kind of help to seek, thinking it would not make a difference, and a preference for self-help. Hence, individuals may need support with identifying what help is available, including both facilitated and self-help options.
The NHS Five Year Forward View first referenced the importance of 'empowering patients' and 'personalised care' and the NHSLTP then stressed 'personalised care'. A recent study noted significant challenges in digital mental health interventions, particularly regarding a lack of personalisation. In summary, there is a need for digitally enabled mental health care which is personalised, includes self-help, and is supported by good quality, contemporaneous evidence, and although the NHS has criteria for assessing digital technology, they no longer have provision for recommending apps to the public.
Emotion Regulation (ER) Technology ER is defined as: "shaping which emotions one has, when one has them, and how one experiences or expresses these emotions". It entails regulating positive and negative emotions, dependent upon goals. Since the 1990s, there has been vast research into the field of ER, for example, it was proposed that ER is necessary for daily functioning. It has also been found that deficits in ER appear to be relevant to the development, maintenance, and treatment of mental health conditions (such as, depression, borderline personality disorder, substance use, eating disorders, somatoform disorder, and other symptoms), hence, ER is transdiagnostic. It has been outlined the importance of cognitive reappraisal in ER.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults (aged 18 years and above).
- •Currently on the waiting list for a specific IAPT service.
- •Experiencing an anxiety disorder and/or depression (scoring 10 or above on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) measure for depression or scoring eight or above on the Generalised Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) measure for anxiety) (The National Collaborating Centre for Mental Health, 2021), when assessed by the IAPT service.
- •Own a mobile phone they can use Betwixt on.
- •Comfortable with using a phone for extended periods of time.
- •Able to give informed consent.
排除标准
- •Sufficient English reading ability, due to the narrative nature of Betwixt. This will be ascertained by ensuring that the participant can read and understand the PIS, and information outlining the narrative nature of Betwixt will also be included.
- •Available for up to seven weeks whilst on the IAPT waiting list. There is flexibility, for example, if a participant has a planned holiday whilst on the IAPT waiting list, the study can be delayed for two weeks (if the waiting time allows).
研究组 & 干预措施
Betwixt app intervention
Betwixt app intervention
干预措施: Betwixt app intervention (Other)
结局指标
主要结局
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
时间窗: Every second day from enrolment to the end of study (6 or 7 weeks per participant).
Measure of emotion regulation. 18 items, 5-point Likert scale. Higher scores indicate more difficulty in emotion regulation. Total score ranges from 18 to 90.
Patient Health Questionnaire-2 (PHQ-2)
时间窗: Every second day from enrolment to the end of study (6 or 7 weeks per participant).
Measure of low mood/psychological distress. Two items, 4-point Likert scale. Higher scores indicate more severe depression symptoms. Total score ranges from zero to six, where three or above indicates depression.
Generalised Anxiety Disorder-2 (GAD-2)
时间窗: Every second day from enrolment to the end of study (6 or 7 weeks per participant).
Measure of generalised anxiety/psychological distress. Two items, 4-point Likert scale. Higher scores indicate more severe generalised anxiety symptoms. Total score ranges from zero to six, where three or above indicates anxiety.
次要结局
- Cognitive Emotion Regulation Questionnaire - Short (CERQ-short)(Every second day from enrolment to the end of study (6 or 7 weeks per participant).)
- Self-Compassion Scale - Short Form (SCS-SF)(Every second day from enrolment to the end of study (6 or 7 weeks per participant).)
- Patient Health Questionnaire-9 (PHQ-9)(Every second day from enrolment to the end of study (6 or 7 weeks per participant).)
- Generalised Anxiety Disorder-7 (GAD-7)(Every second day from enrolment to the end of study (6 or 7 weeks per participant).)
- Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS)(Every second day from enrolment to the end of study (6 or 7 weeks per participant).)
- Work and Social Adjustment Scale (WSAS)(Every second day from enrolment to the end of study (6 or 7 weeks per participant).)
