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:
1. Does changing the order of the therapy modules affect how well treatment works or how many patients drop-out of treatment? 2. 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? 3. Does online group therapy work as well to treat common mental health problems as standard care (individual cognitive behavioural therapy \[CBT\])?
Hypotheses:
1. Changing the order of therapy modules will not change how well therapy works or how many people drop-out. 2. 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 3. 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.
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
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
Factorial
Unified Protocol
BehavioralThe UP 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 Cognitive and Behavioural Therapy (CBT) and emotion regulation theories, and the aim is 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. Contents are organised across 8 modules delivered online across 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.
Post-treatment Negative Affectivity (NA) scale
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.
Quality of Life (EuroQol - 5 dimensions; EQ5D)
The EuroQol Group 5-Dimension self-report questionnaire (EQ-5D) measures health-related quality of life across five domains: mobility, self-care, daily activities, pain/discomfort, and depression/anxiety. This measures yields a continuous score with a range between -0.446 to 1.00, where higher scores indicate better quality of life.
Wellbeing (Short-form Warwick and Edinburgh Mental Wellbeing Scale; SWEMWBS)
The Short-form Warwick and Edinburgh Mental Wellbeing Scale (SWEMWBS) is a 7-item self-report scale that measures psychological well-being, with a continuous score ranging between 7 and 35, where a higher score indicates better well-being.
Therapy drop-out
The dropout variable will be derived from group therapy attendance records, where cases that attended more than half (≥6) sessions will be grouped into the reference category (code = 0) and cases that attended less than half (≤5) will be classed as cases that dropped out (code = 1).
Healthcare service utilisation (Modified Adult Service Use Schedule; AD-SUS)
A modfied measure of healthcare service utilisation for health economic analysis. The measure captures binary (yes/no) information about which healthcare services participants have used in the last 3 months and how many times. There is no minimum or maximum score. The responses provided are combined with known healthcare cost values to conduct economic analyses of the study intervention and subsequent impact on other healthcare usage.
Group alliance (Group Climate Questionnaire-Short; GCQ-S)
To control for group alliance levels, participants will complete the 12-item Group Climate Questionnaire-Short (GCQ-S). There are 3 scales; Enaged (scored 0-30 where higher scores show better engagement), Conflict (scored 0-24 where higher scores show greater conflict), and Avoiding (scored 0-18 where higher scores show more avoidance).
Click on the lead sponsor to view all of their trials.
Rotherham Doncaster and South Humber NHS Foundation Trust
Lead sponsor
Innovate UK
Collaborator
University of Sheffield
Collaborator
MindLife UK Ltd
Collaborator
