Wait Less; an online brief psychological intervention to reduce waiting list distress

ISRCTN	ISRCTN55681753
DOI	https://doi.org/10.1186/ISRCTN55681753
Integrated Research Application System (IRAS)	343348
Central Portfolio Management System (CPMS)	61441
Sponsor	University of Cambridge
Funder	National Institute for Health and Care Research

Submission date: 15/03/2024
Registration date: 08/01/2026
Last edited: 08/01/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study wants to test whether an online version of talking therapy for young people dealing with depression helps them cope better while on the waiting list for specialist Child and Young People’s Mental Health Services. The digital treatment was developed with young people, parents, and staff working in mental health services from an existing talking therapy. It is hoped that this app, called My Mind Works or MMW, might help young people on the CYPMHS waiting list feel better, with some possibly achieving complete recovery without needing further treatment. Young people played a significant role in shaping the project, advocating for the use of the term "depression" rather than "low mood" to describe the targeted difficulties. They also emphasised that access to MMW should not affect their place on the waiting list, a concern the team shares and pledges to address. Additionally, young people stressed that neurodiverse individuals should have access to MMW. The team has confirmed with clinics that neurodiverse young people with depression are included in the same waiting lists as others and will have access to the research if they choose to participate. The research is supported by separate advisory panels consisting of young people, parents/carers, and staff who work in, manage and organise Children and Young People’s Mental Health Services. These panels will assist in developing research processes and materials, reviewing results, and disseminating findings to others. This study will test whether MMW is acceptable and useful for young people and whether we can encourage enough young people to take part in the study. Answers young people give about their mood will help us understand how many young people would need to take part in a larger study to check if MMW help young people recover from depression and if it is value for money.

Who can participate?
Young people aged 12 to 17 years old recruited to CYPMHS with low mood or depression

What does the study involve?
Young people who agree to take part will complete some questionnaires and then will either have access to MMW for 8 weeks or wait as usual. Access to MMW will be random, like the flip of a coin. All young people will repeat the questionnaires at 10 weeks and at 18 weeks, at which point those who did not have access to MMW will be given access if they want it. Some young people, parents and staff working for them will also have the opportunity to talk about their experience with researchers if they wish to.

What are the possible benefits and risks of participating?
All young people will get access to MMW, which they may find helpful in managing their distress whilst waiting for treatment. However, half the participants will wait as usual for the first 18 weeks of the study. All young people will have normal access to a duty mental health practitioner in their mental health service, should they need urgent support. All participants will need to spend time completing questionnaires.

Where is the study run from?
University of Cambridge (UK)

When is the study starting and how long is it expected to run for?
March 2026 to March 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Prof Tamsin Ford, tjf52@cam.ac.uk

Contact information

Prof Tamsin Ford
Public, Scientific, Principal investigator

Department of Psychiatry
University of Cambridge
Hershel Smith Building
Robinson Way
Cambridge Biomedical Campus
Cambridge
CB2 0SZ
United Kingdom

ORCID ID	0000-0001-5295-4904
Phone	None available
Email	tjf52@cam.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Sequential
Purpose	Health services research, Supportive care, Treatment
Study type	Participant information sheet
Scientific title	Wait Less: co-designing and evaluating an online self-help brief psychosocial intervention (MMW) for young people with mood-related mental health problems to reduce waiting lists in specialist children and young people’s mental health services
Study acronym	Wait Less
Study objectives	Working with adolescents, parents, charities and NHS professionals, the study aims to co-produce a low-intensity digital version of the NICE-recommended Brief Psychological Intervention (MMW or My Mind Works), to assess its acceptability, feasibility and utility to young people on the mental health service waiting list. The study will determine if MMW can fill the gap between referral and face-to-face treatment in specialist Children and Young People’s Mental Health Services (CYPMHS). The study has two parts: initial coproduction, which has been completed, and the feasibility RCT, which is the subject of this registration. Coproduction [completed] 1. Explored young people and parents/carers’ experiences of waitlists and informed the clinical governance for MMW through interviews with NHS managers and clinicians working with young people who are waiting for treatment 2. Codesigned MMW, basing the content and process on the existing evidence for face-to-face BPI, iteratively incorporating feedback from young people, parents, clinicians, working with software engineers: 3. Evaluated the MMW prototype for clinical usability, feasibility, safety and managerial acceptability with between 5 young people each in two NHS clinics Feasibility RCT This study is a pilot trial of MyMindWorks (MMW) versus waiting as usual in 10 NHS CYPMHS within two NHS Foundation Trusts to test recruitment, retention, and research processes. Progression to full trial will depend on defined success criteria.
Ethics approval(s)	Submitted December 2025
Health condition(s) or problem(s) studied	Depression in young people aged 12 to 17 years
Intervention	Feasibility RCT This study is a pilot trial of MyMindWorks (MMW) versus waiting as usual in 10 NHS CYPMHS within two NHS Foundation Trusts to test recruitment, retention, and research processes. The trial will recruit 80 young people, aged between 12 and 17 years (40 in each arm), randomised to MMW or waiting as usual. Eligible participants will be randomised via a bespoke web-based randomisation system hosted by the Norwich Clinical Trials Unit. Progression to full trial will depend on the success criteria defined below. MyMindWorks (MMW) is an online application for adolescents with mood-related mental health difficulties. MMW is designed for users between the ages of 12 and 17 years of both natal sexes and all genders. The application is self-administered and can be activated multiple times following online registration by a single user who has sole access via a secure, unique code number. The program can be opened and closed multiple times over a period of eight weeks from registration. The design is aimed at a primary interface of hand-held mobile devices, but will also be fully accessible on tablets and computers. The content of MMW is based on that used in the face-to-face intervention known as Brief Psychosocial Intervention (BPI). This new conversational treatment was confirmed in 2017 as being as clinically effective as cognitive behavioural therapy for depressed adolescents. The National Institute for Health and Care Evaluation adopted BPI in 2019 as an approved intervention for depressed adolescents aged 11-19 years. BPI focuses on psychoeducation regarding how the mind does and does not work, social and personal prescribing of activities, skills and healthy habits to reduce social isolation and enhance interpersonal behaviours. BPI encourages and promotes positive support from the environment and emphasises the value of learning and repeating healthy behaviours and monitoring mentalising (i.e. mental activity). MMW translates the content of BPI into a digital format for use as a stand-alone self-administered low-intensity intervention focused on empowering young people to support reducing symptoms and aiding wellbeing.
Intervention type	Behavioural
Primary outcome measure(s)	Depression measured using the Moods and Feelings Questionnaire (MFQ) at baseline, 10 and 18 weeks post baseline
Key secondary outcome measure(s)	Recruitment, retention and engagement with MMW measured using app analytics at 18 weeks Impairment measured using the Impact Scale of the Strengths and Difficulties Questionnaire at baseline, 10 and 18 weeks Waiting list choice (continue waiting, return to the referrer, withdraw) measured using a bespoke question at 10 weeks Quality of life measured using the EuroQol EQ-5D-5L at baseline, 10 and 18 weeks Service costs and use measured using the Client Service Receipt Inventory at baseline, 10 and 18 weeks
Completion date	31/03/2027

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Young people aged 12 to 17 years old 2. Recruited from the Children and Young People's Mental Health Service waitlist for treatment because of low mood or depression. Eligibility commences from the moment of allocation to the waiting list and persists until a young person chooses to leave the waiting list or is offered a treatment by the service. From prior RCT research, it has been inferred that the median age of wait-list participants in scope for MMW will be 15 years and 3 months, and 70% will be female sex as assigned at birth.
Key exclusion criteria	There are no initial participant exclusion criteria. Young people in crisis are likely to come off the waiting list so by definition will no longer be eligible. Some young people may deteriorate whilst part of the study and require active treatment from the Child and Young People's Mental Health Service, which will be monitored in terms of safety and numbers to inform sample size calculation for a definitive trial. Access to MMW would not be withdrawn should this occur, unless advised to do so by the treating practitioners practitioner. Such discussions will be carefully recorded and monitored.
Date of first enrolment	01/03/2026
Date of final enrolment	31/05/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Central and North West London NHS Foundation Trust

Trust Headquarters
350 Euston Road
Regents PLACE
London
NW1 3AX
England

Berkshire Healthcare NHS Foundation Trust

London House
London Road
Bracknell
RG12 2UT
England

University of Cambridge

The Old School
Trinity Lane
Cambridge
CB2 1TN
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	Data from this feasibility trial will be made available to researchers via the Department of Psychiatry's data-sharing portal: https://portal.camide.cam.ac.uk/

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/03/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).