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

NCT06722781 | Recruiting DMC

• 1 other identifier: RDaSH0348
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 2

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:

• 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

Keywords

Psychological interventions; Internalizing disorders; High intensity CBT; Common mental health problems; Unified Protocol; Digitally-enabled therapy; Group therapy; Digital Health Technology; NHS Talking Therapies; Personalised treatment; Pragmatic clinical trial; Transdiagnostic

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 11 months

Secondary Outcomes (3)

• 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).

Other Outcomes (2)

• Healthcare service utilisation (Modified Adult Service Use Schedule; AD-SUS)

  Through study completion, an average of 11 months

• Group alliance (Group Climate Questionnaire-Short; GCQ-S)

  3 Weeks (Session 3)

Study Arms (5)

Standard Unified Protocol (UP)

ACTIVE COMPARATOR

Standard sequence of UP modules, 1, 2, 3, 4, 5 6, 7, 8.

Behavioral: Unified Protocol

UP Sequence 1

ACTIVE COMPARATOR

Sequence of modules, 1, 2, 5, 7, 4, 3, 6, 8.

Behavioral: Unified Protocol

UP Sequence 2

ACTIVE COMPARATOR

Sequence of modules, 1, 2, 6, 3, 5, 7, 8.

Behavioral: Unified Protocol

UP Sequence 3

ACTIVE COMPARATOR

Sequence of modules, 1, 2,4, 6, 7, 5, 3, 8.

Behavioral: Unified Protocol

UP Sequence 4

ACTIVE COMPARATOR

Sequence of modules, 1, 2, 7, 5, 3, 4, 6, 8.

Behavioral: Unified Protocol

Interventions

Unified Protocol BEHAVIORAL

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.

Also known as: Transdiagnostic UP, Barlow's Unified Protocol for emotional disorders

Standard Unified Protocol (UP); UP Sequence 1; UP Sequence 2; UP Sequence 3; UP Sequence 4

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rotherham Doncaster and South Humber NHS Foundation Trust: lead
• Innovate UK: collaborator
• University of Sheffield: collaborator
• MindLife UK Ltd: collaborator

Study Sites (2)

Rotherham Doncaster and South Humber NHS Foundation Trust

Doncaster, South Yorkshire, DN4 8QN, United Kingdom

NOT YET RECRUITING

Devon Partnership NHS Trust

Exeter, EX2 5AF, United Kingdom

RECRUITING

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Related Links

• Open Science Framework (OSF) pre-registration of research project including copy of full protocol and analysis plan.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jaime Delgadillo, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Simmonds-Buckley, PhD

CONTACT

+443000 212 456; melanie.simmonds-buckley@nhs.net

Jeannie McKie, PGDiP

CONTACT

+443000 212 456; j.mckie@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The cluster randomisation sequence will be generated by a research assistant who is not involved in recruitment, treatment delivery or data analysis.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pragmatic factorial cluster randomised controlled trial of a transdiagnostic treatment for common mental health problems

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: December 9, 2024
• Study Start: April 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)