Condition category
Mental and Behavioural Disorders
Date applied
02/07/2020
Date assigned
06/07/2020
Last edited
06/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many teenagers will be exposed to a potentially traumatic event at some point before they are 18 years old, and many of them will develop post-traumatic stress disorder (PTSD). PTSD is distressing and often causes problems at home and at school. Cognitive therapy for PTSD is very effective when young people can go to regular weekly face-to-face appointments to see a trained therapist. However, face-to-face therapy is sometimes not offered to young people due to a shortage of trained therapists, and some young people cannot attend the clinic for many reasons. This means that many young people with PTSD miss out on effective treatments.
Researchers have developed a progressive web app to deliver cognitive therapy to young people with PTSD with a smartphone, tablet or computer. They want to find out what young people and their carers or parents think of this way of delivering therapy. They want to find out how easy it is to recruit young people and to engage them in the treatment to inform a larger trial in the future. They also want to see whether symptoms of PTSD and other problems such as depression and anxiety reduce after doing the therapy and how this compares to natural recovery.

Who can participate?
Young people (aged 12-17) whose main presenting problem is PTSD following a single-event trauma (e.g. serious accidents or assaults)

What does the study involve?
Participants are randomly allocated to either receive online therapy to receive delayed treatment, where they will wait 16 weeks before receiving the online treatment. Face-to-face therapy will be offered to young people allocated to the waitlist condition if clinics are running as usual and offering face-to-face appointments following the COVID-19 pandemic. The online treatment involves therapist-supported online delivery of all components from a face-to-face CT manual, including psycho-education, reclaiming life, developing a narrative of the trauma, re-appraisal of trauma-related cognitions, updating the trauma memory, stimulus discrimination training, developing a relapse-prevention blueprint. Work with parents is via a parallel parent App. Young people are supported to complete their treatment via a weekly phone call from their therapist. The researchers will carry out detailed assessments before and after treatment to see if symptoms are reduced after doing the therapy, and how symptom improvement compares across the two groups. These will be repeated at 38 weeks (follow-up) for the active treatment group only to see if any treatment effects are long-lasting.

What are the possible benefits and risks of participating?
Sometimes this therapy, whether delivered face-to-face or online, may be upsetting. However, a therapist will be available throughout treatment to support young people if this happens. In addition, the online therapy has already been used by some young people. They did not experience any disadvantages or risks in using the online therapy. There is a 50% chance young people will be allocated to the delayed treatment group. This means that they will be asked to wait for 16 weeks before receiving the online therapy. The researchers may also be able to offer young people face-to-face treatment after the 16-week wait, if preferred, and if clinics are running normally at the time. Young people can seek support from their GP if they feel they need support while waiting for treatment to begin. The evidence so far shows that young people are likely to be helped by receiving treatment through this study. Young people will have a 50% chance of being allocated to online therapy without having to wait. The researchers think that the online therapy will be effective in treating PTSD. Face-to-face cognitive therapy for PTSD has been shown to be is very effective, and the researchers have designed the new online therapy using the same treatment components as this treatment.

Where is the study run from?
King’s College London (UK)

When is the study starting and how long is it expected to run for?
June 2020 to February 2022

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr Patrick Smith
patrick.smith@kcl.ac.uk

Trial website

https://www.optyc.org/

Contact information

Type

Scientific

Primary contact

Dr Patrick Smith

ORCID ID

http://orcid.org/0000-0002-0743-7972

Contact details

Henry Wellcome Building
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0506
patrick.smith@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 262807, CPMS 42768

Study information

Scientific title

Internet-delivered cognitive therapy (iCT) for young people with post-traumatic stress disorder (PTSD) - early-stage randomized controlled trial

Acronym

OPTYC

Study hypothesis

This is an early stage trial with two arms: a newly developed internet-delivered Cognitive Therapy (iCT) programme to treat PTSD in adolescents, and a Wait List condition. The objectives of the RCT are to: provide feasibility data on acceptability, compliance, retention, and delivery; and to provide initial estimates of the effect of iCT on symptoms of PTSD, anxiety and depression relative to a wait-list condition.

Ethics approval

Approved 30/06/2020, London Bridge Research Ethics Committee (Skipton House, 80 London Road London SE1 6LH, UK; +44 (0)207 104 8019; londonbridge.rec@hra.nhs.uk), REC ref: 19/LO/1354

Study design

Two-arm parallel-group single-blind (outcome assessor) early-stage randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Post-traumatic stress disorder (PTSD)

Intervention

Randomisation will be carried out by an independent clinical trials unit. Individual patient-level randomisation, with allocation in a 1:1 ratio, using minimisation methods employing two factors (gender and symptom severity), will be used to randomise into one of two arms:

1. Internet-delivered Cognitive Therapy (iCT; n = 17)
This comprises therapist-supported online delivery of all components from our face-to-face Cognitive Therapy (CT) manual (Smith et al., 2010), including: psycho-education, reclaiming life, developing a narrative of the trauma, re-appraisal of trauma-related cognitions, updating the trauma memory, stimulus discrimination training, developing a relapse-prevention blueprint. Young people are supported to complete treatment via a weekly phone call from their therapist. There is a separate online programme for parents and carers.

2. Wait List (WL; n = 17)
Patients allocated to WL will be asked to wait for 16 weeks before being offered iCT. If preferred, and if clinics are open and functioning as usual at the time, patients will be able to opt for face-to-face CT-PTSD after the 16-week wait.

Assessments will take place at pre-treatment (0 weeks), mid-treatment (6 weeks post-randomisation), post-treatment (16 weeks post-randomisation), and at follow-up (38 weeks post-randomisation). Follow up assessments at 38 weeks will be conducted for the iCT arm only.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

As this is an early-stage trial, the primary outcomes are feasibility outcomes and adherence metrics. Feasibility data on acceptability, compliance, retention, and delivery will be collected to enable an estimation of key parameters to inform a larger trial. This is in line with MRC guidance.

The following feasibility data on acceptability will be collected during the trial recruitment phase at the pre-intervention assessment and during the randomisation phase (June 2020- August 2021):
1. The total number of young people referred to the trial by (i) schools, (ii) Child and Adolescent Mental Health Services (CAMHS), or (iii) GP or self-referral
2. Number of young people screened in schools, and of these, the proportion who are considered to be eligible at school and proceed to a phone call with family
3. Number and proportion of young people in schools scoring above cut-off on a validated screening questionnaire (a score of ≥17 on the Children’s Revised Impact of Event Scale, CRIES-8); relative to the number of young people screened in schools
4. The number and proportion of young people in schools who score above cut-off on the CRIES-8 but decline further participation with the trial (relative to those scoring above cut-off)
5. The number and proportion of young people in schools who score above cut-off on CRIES-8 and consent to further assessment but are deemed ineligible at baseline assessment (relative to those deemed eligible at baseline assessment)
6. Number of assessment appointments offered to participants (via any referral route)
7. Number and proportion of assessment appointments attended by participants, relative to the number of appointments offered, reported by referral source (schools, CAMHS, GP referral, and self-referral)
8. Reasons for not attending assessment appointments (count and percentages) reported by referral source (schools, CAMHS, GP referral, and self-referral)
9. Number and proportion of young people who, at the baseline assessment, consent to participation in the trial (number consented / number attended assessment). Reasons for not consenting if known (count and percent)
10. Number and proportion of young people eligible for the trial after baseline assessment (number eligible at baseline interview/number assessed for eligibility at baseline interview)
11. Number of young people who are randomised, and proportion of consented young people who are randomised (number randomised / number consented)
12. Reasons for withdrawing from the trial if known
13. Number retained in study at 16 weeks (post-treatment) and at 38 weeks (follow-up), and proportions of those who start treatment that are retained (number retained / number started, and number retained/number randomised), by arm

Acceptability will also be gauged by carrying out qualitative interviews with young people about the acceptability of the research procedures, the assessment measures and views of randomisation at 16 weeks (post-treatment).

The following feasibility data on adherence, compliance and delivery will be collected in the iCT arm throughout the treatment phase (0-12 weeks):
14. Number of times logged into the programme per week and in total
15. Time spent logged in per week and in total
16. Number of modules completed in total and according to device used (phone, tablet, computer)
17. Number of therapist phone calls attended per week and in total, and the number of missed phone appointments
18. Time spent on phone calls per week and in total
19. Number of messages to/from therapist per week and in total
20. Number and proportion of young people who start treatment (number starting treatment/number randomised)
21. Number of weeks of therapy completed
22. Reasons for dropping out of treatment if known

Feasibility data on retention will be collected, including the reasons for withdrawing from the trial, if known and the number retained in the study at 16 weeks (post-treatment) and at 38 weeks (follow-up), and proportions of those who start treatment that are retained (number retained / number started, and number retained/number randomised), by arm.

The primary clinical outcome is the presence or absence of a diagnosis of post-traumatic stress disorder (PTSD) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) published by the American Psychiatric Association, determined using a gold-standard semi-structured clinical interview: the Clinician-Administered PTSD Scale for DSM-5 - child and adolescent version (CAPS-5-CA), administered at 0 and 16 weeks after randomisation. This is a clinician-administered interview and will be administered by trained, reliable raters who are blind to treatment allocation.

Secondary outcome measures

Young person completed outcome measures:
1. PTSD symptom severity measured using the CAPS-CA-5 at 0 (baseline) and 16 weeks post-randomisation (post intervention)
2. PTSD symptoms measured using the Child Post Traumatic Stress Scale (CPSS-5) and at 0, 16 and 38 weeks post randomisation (follow up)
3. Re-experiencing the traumatic event and avoidance measured using the Children’s Revised Impact of Event Scale - 8 item version (CRIES-8) at 0, 6, 16, and 38 weeks
4. Anxiety and depression measured using the Revised Children’s Anxiety and Depression Scale (RCADS-C) at 0, 16 and 38 weeks
5. Negative trauma-related cognitions and appraisals measured using the Child Post Traumatic Cognitions Inventory (CPTCI) at 0, 6, 16 and 38 weeks
6. Health-related quality of life using the Child Health Utility Index 9D (CHU-9D) measured at 0, 16 and 38 weeks

Parent/carer completed outcome measures:
7. Emotional and behavioural problems measured using the Strength & Difficulties Questionnaire (SDQ-P) at 0, 16 and 38 weeks
8. Depression and anxiety measured using the Revised Children’s Anxiety and Depression Scale (RCADS-P) at 0, 16 and 38 weeks
9. Health economics measured using the Child & Adolescent Service Use Schedule (CA-SUS) at 0, 16 and 38 weeks

These outcomes will only be repeated at 38 weeks post-randomisation (follow-up) in the RCT for the active treatment arm

Overall trial start date

01/12/2017

Overall trial end date

26/02/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Young people:
1. Aged 12-17 years old
2. Main presenting problem is PTSD (diagnosed using CAPS-5-CA) and there is a not a co-morbid problem that would preclude treatment of PTSD
3. PTSD symptoms relate to a single trauma
4. Participant has access to compatible smartphone or larger computing device (e.g. laptop, desktop computer, iPad) with internet access and to a safe and confidential space in which to engage in iCT
5. Participant speaks English to a level that allows therapy without the need for an interpreter, and reads English to a level that allows independent use of iCT

Parents or carers:
1. Parent or carer of a young person who meets all of the inclusion criteria above and none of the exclusion criteria below
2. Parent or carer speaks English to a level that allows participation in therapy without the need for an interpreter, and reads English to a level that allows independent use of iCT
3. Parent or carer has access to compatible smartphone or larger computing device (e.g. laptop, desktop computer, iPad) with internet access

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

34

Participant exclusion criteria

Young people:
1. Brain damage
2. Intellectual disability
3. Pervasive developmental disorder or neurodevelopmental disorder
4. Other psychiatric diagnosis that requires treatment before PTSD
5. Moderate to high risk to self
6. Ongoing trauma-related threat
7. Started treatment with psychotropic medication, or changed medication, within the last 2 months
8. Currently receiving another psychological treatment
9. Has already received trauma-focused CBT in relation to the same traumatic event that they are currently seeking treatment for

Parents or carers:
Parents or carers are not eligible if their son or daughter meets the exclusion criteria above. There are no additional exclusion criteria for parents or carers

Recruitment start date

14/07/2020

Recruitment end date

01/11/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Maudsley Hospital
South London and Maudsley NHS Foundation Trust Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

Hellesdon Hospital
Norfolk and Suffolk NHS Foundation Trust Drayton High Road
Norwich
NR6 5BE
United Kingdom

Trial participating centre

Erlegh House
Berkshire Health NHS Foundation Trust University of Reading
Reading
RG6 6BZ
United Kingdom

Trial participating centre

Warneford Hospital
Oxford Health NHS Foundation Trust Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Trial participating centre

NELFT NHS Foundation Trust
651 The Crescent Colchester Business Park
Colchester
CO4 9YQ
United Kingdom

Trial participating centre

Northern Health Centre
Whittington Health NHS Foundation Trust 580 Holloway Road
London
N7 6LB
United Kingdom

Trial participating centre

Fulbourn Hospital
Cambridge and Peterborough NHS Foundation Trust Elizabeth House Cambridge Road
Cambridgeshire
CB21 5EF
United Kingdom

Trial participating centre

Memorial Hospital
OXLEAS NHS Foundation Trust Highpoint House Shooters Hill
London
SE18 3RZ
United Kingdom

Sponsor information

Organisation

Joint Institute of Psychiatry, Psychology & Neuroscience and the South London and Maudsley NHS Foundation Trust.

Sponsor details

Research & Development Office
Box P005
Institute of Psychiatry
Psychology & Neuroscience
King's College London
Denmark Hill Campus
16 De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0790
reza.razavi@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Government

Funder name

Medical Research Council Developmental pathway Funding Scheme (DPFS) MRC reference: MR/P017355/1

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers will publish feasibility data and exploratory clinical outcome data from the randomized controlled trial. They will not provide details of case histories, and will not provide illustrative quotes from participants which contain information which may compromise anonymity. In presenting numerical data, we will ensure that no participant is identifiable.

A report will be prepared for the sponsor and funders.

The researchers plan to publish:
1. A peer-reviewed paper reporting the trial protocol
3. A peer-reviewed paper reporting the feasibility trial outcomes

They will also prepare a report on users’ views on the iCT programme.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

26/02/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2020: Trial's existence confirmed by London Bridge Research Ethics Committee.