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Recruiting NCT06722781

NCT06722781 Trial of an Online Group Psychotherapy Intervention for Common Mental Health Disorders

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Clinical Trial Summary
NCT ID NCT06722781
Status Recruiting
Phase
Sponsor Rotherham Doncaster and South Humber NHS Foundation Trust
Condition Common Mental Health Problems
Study Type INTERVENTIONAL
Enrollment 660 participants
Start Date 2025-04-30
Primary Completion 2025-12-31

Eligibility & Interventions

Sex All sexes
Min Age 17 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Unified Protocol

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 660 participants in total. It began in 2025-04-30 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Contact & Investigator

Central Contact

Melanie Simmonds-Buckley, PhD

✉ melanie.simmonds-buckley@nhs.net

📞 +443000 212 456

Principal Investigator

Jaime Delgadillo, PhD

PRINCIPAL INVESTIGATOR

University of Sheffield

Frequently Asked Questions

Who can join the NCT06722781 clinical trial?

This trial is open to participants of all sexes, aged 17 Years or older, studying Common Mental Health Problems. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06722781 currently recruiting?

Yes, NCT06722781 is actively recruiting participants. Contact the research team at melanie.simmonds-buckley@nhs.net for enrollment information.

Where is the NCT06722781 trial being conducted?

This trial is being conducted at Doncaster, United Kingdom, Exeter, United Kingdom.

Who is sponsoring the NCT06722781 clinical trial?

NCT06722781 is sponsored by Rotherham Doncaster and South Humber NHS Foundation Trust. The principal investigator is Jaime Delgadillo, PhD at University of Sheffield. The trial plans to enroll 660 participants.

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology