UpLift-X Trial 1: A Cluster Factorial Randomised Controlled Trial of Digitally-enabled Group Psychotherapy for Common Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 4
- 主要终点
- Post-treatment Negative Affectivity (NA) scale
研究概览
简要总结
The goal of this clinical trial is to understand how to deliver online group therapy for adults with common mental health problems in a personalised way. This study will test a new online group therapy program for various common mental health problems like anxiety and depression. The therapy is based on an approach called the Unified Protocol, which includes eight modules teaching different coping skills. The therapy will be delivered via a video call and a website, which will also have helpful videos and information about coping skills.
Aims:
- Does changing the order of the therapy modules affect how well treatment works or how many patients drop-out of treatment?
- Do some modules work better for different patients based on their individual features and if patients receive the therapy module that is most likely to be helpful for them first, does it mean they have a better chance of feeling better by the end of treatment?
- Does online group therapy work as well to treat common mental health problems as standard care (individual cognitive behavioural therapy [CBT])?
Hypotheses:
- Changing the order of therapy modules will not change how well therapy works or how many people drop-out.
- Patients with specific profiles (based on their individual characteristics) will benefit more from some treatment modules and will see greater improvements in their symptoms if they received their best therapy module before other modules
- There will be no differences in overall treatment outcome or dropout rates when comparing online group therapy vs. individual CBT
Researchers will compare whether delivering the modules in different orders, with five different versions of the treatment, to see if changing the order of therapy modules affects how well it works or drop-out rates. Researchers will test how best to match patients to the most helpful parts of treatment for them. The group therapy outcomes and costs will also be compared to data from patients who have had individual CBT to see how the intervention compares to standard care.
Participants will:
- Complete online symptom questionnaires before treatment starts and before each therapy session
- Attend 12 weekly group therapy sessions delivered by a video call on a website (called Uplift-X).
- Access online resources like videos and practice exercises to use between therapy sessions.
- Complete the online symptom questionnaires again at the end of treatment and 6 months later.
详细描述
The study protocol - including a full statistical analysis plan was pre-registered and made publicly accessible in the Open Science Framework on the 4th of October 2024 (available here - https://osf.io/vup9c/).
A pragmatic, multi-site, cluster factorial randomised controlled trial, involving National Health Service (NHS) Talking Therapies (NHS-TT) services for anxiety and depression (formerly known as IAPT services) in England. The "UPLift" digitally enabled group intervention, based on the Unified Protocol, will be available to patients with common mental disorders (and comorbidities) that are eligible to receive high intensity Cognitive Behavioural Therapy (CBT) in NHS-TT services, following national guidelines (National Collaborating Centre for Mental Health, 2024). The Unified Protocol is a transdiagnostic treatment that was designed to be relevant to a wide range of emotional disorders, given the common co-occurrence of depression, anxiety, somatoform and dissociative symptoms. It is based on CBT and emotion regulation theories, and aims to support patients to apply a series of emotion regulation skills that target the core common vulnerabilities that underlie a range of mental health problems: neuroticism, low perceived control, and overestimation of threat. The protocol follows the principle of parsimony, by including the minimum number of empirically validated techniques that would make it accessible, uncomplicated, and effective for the maximum number of patients with various combinations of symptoms and problems. Contents are organised across 8 modules delivered online at 12 weekly 1.5 hour sessions and will include a combination of internet-based resources (self-monitoring questionnaires, psychoeducational videos, skills practices linked to each module) and group therapy sessions delivered by a qualified cognitive behavioural therapist.
The unit of randomisation (cluster) will be each participating NHS-TT service. NHS Trusts are wider organisations that manage one or more NHS-TT services, so the unit of randomisation is the local team. All patients treated in the same local area service will be members of the same cluster. Participating services will be randomly allocated to one of 5 arms. Each arm will include the same 12-session online group Unified Protocol treatment but organised in a different sequence. The first two modules will remain fixed at the start of the intervention, as these introduction sessions are necessary to orient all patients to the treatment and to establish a cohesive group process. Similarly, the final module is fixed at the end of the intervention, as it includes an overall review of all coping skills, and it focuses on relapse prevention. The middle modules cover specific emotion regulation skills and are most amenable to personalisation (e.g., some may be more or less effective for specific patients). These prescriptive modules will be delivered in different sequences across each of the trial arms.
Participants will complete baseline measures on entry to the study, weekly symptom outcome measures prior to each session and a post-treatment (session 12) and 6-month follow-up survey. The primary outcome will be Negative affectivity (NA), based on a composite score pooling items from Patient Health Questionnaire-9 (PHQ-9; depression), Generalized Anxiety Disorder-7 scale (GAD-7; anxiety) and Work and Social Adjustment Scale (WSAS; functioning). Secondary outcomes will be Quality of life (EuroQol - 5 dimensions; EQ5D), Wellbeing (Warwick and Edinburgh Mental Wellbeing Scale; WEMWBS) and drop out from treatment.
Researchers will also collect anonymised clinical health records for all patients accessing individually delivered CBT in the participating services during the period of the clinical trial. These data will include demographics, clinical care and clinical outcomes. This will enable researchers to undertake comparisons of clinical and cost-effectiveness using a case-control matching strategy described in the statistical analysis plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The cluster randomisation sequence will be generated by a research assistant who is not involved in recruitment, treatment delivery or data analysis.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •17 years old and over
- •Literate and fluent in the English language, which would enable group interactions and learning via online materials
- •With access to an internet-connected device (e.g., computer, phone) and confidential space
- •Referred to NHS-TT services
- •Assessed by a qualified psychological professional and deemed to be eligible for high intensity CBT (this includes low risk of harm to self or others)
- •Currently on waiting list for high intensity CBT and not accessing any other psychological interventions. This includes patients accessing pharmacotherapy but who are additionally seeking psychological treatment
- •Presenting symptoms of one or more internalizing disorders (major depressive disorder, generalised anxiety disorder, panic disorder, agoraphobia, specific phobias, somatoform disorder, obsessive-compulsive and related disorders, body dysmorphic disorder, post-traumatic stress and related disorders)
排除标准
- •16 years old and under
- •Not able to speak or read English fluently, which would require more individualised support with interpreters
- •No access to internet-connected device or confidential space to engage with digital intervention
- •Not involved with NHS-TT services
- •Assessed by a qualified psychological professional and not deemed to be eligible for high intensity CBT on the basis of mental health condition and/or risk assessment (e.g., acute risk of suicide at the time of assessment)
- •Already accessing a high intensity psychotherapy or other forms of psychological treatment (e.g., private therapy, counselling)
- •Presenting with symptoms of eating disorders, substance use disorders, psychotic disorders, personality disorders, bipolar disorders identified at the time of initial assessment.
结局指标
主要结局
Post-treatment Negative Affectivity (NA) scale
时间窗: Through study completion, an average of 11 months
A transdiagnostic construct that includes commonly occurring symptoms of low mood, negative thoughts, fear/anxiety, social and interpersonal difficulties. NA can be measured by pooling all items from the PHQ-9, GAD-7 and WSAS into a single scale which attributes specific weights to each item according to their strength of association with an underlying dimension of general psychological distress. To derive this NA scale, we will apply the item-weighting methodology proposed by. This involves multiplying the raw item scores across all three questionnaires with the non-standardized factor loadings. This yields a continuous NA severity score ranging between 0 and 69.58, with a reliable change index.
次要结局
- Quality of Life (EuroQol - 5 dimensions; EQ5D)(Through study completion, an average of 11 months)
- Wellbeing (Short-form Warwick and Edinburgh Mental Wellbeing Scale; SWEMWBS)(Through study completion, an average of 11 months)
- Therapy drop-out(12 weeks (at the end of therapy).)