Trial of an Online Group Psychotherapy Intervention for Common Mental Health Disorders

Summary

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.

Conditions

• Common Mental Health Problems
• Anxiety
• Depression Disorders

Interventions

BEHAVIORAL

Unified Protocol

The 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.

Sponsors & Collaborators

• Innovate UK

  collaborator OTHER_GOV

• University of Sheffield

  collaborator OTHER

• MindLife UK Ltd

  collaborator UNKNOWN

• Rotherham Doncaster and South Humber NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Jaime Delgadillo, PhD · University of Sheffield

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-30

Primary Completion

2025-12-31

Completion

2026-09-30

Countries

• United Kingdom

Study Locations