Plain English Summary
Background and study aims
Many people who access IAPT services have psychotic experiences in addition to common mental disorder, and are less likely to recover from depression and anxiety than people without psychotic experiences. We want to understand whether providing CBT therapists in IAPT services with additional skills training can help them to work more effectively with these service users, increasing the likelihood of recovery.
We also want to assess the feasibility of collecting additional health economics data from these patients to inform a definitive trial planned for 2020.
Who can participate?
Adults aged 17+ who access CBT therapy in IAPT services with the presence of psychotic experiences will be eligible to take part.
What does the study involve?
This feasibility study will train 8-10 therapists in each of three teams within the IAPT service (one team per mental health Trust). The training package will support therapists to deliver care to service users with psychotic experiences and common mental disorder; people who have scored above a threshold on the Community Assessment of Psychic Experiences (CAPE) questionnaire, referred to as CAPE+. Following training, therapists will treat an average of 3 CAPE+ service users each.
What are the possible benefits and risks of participating?
Participation in this study in unlikely to provide any direct benefits, but it may help to enhance IAPT services in the future. It may benefit participants if they ever need to use IAPT services again. We do not envisage any harm from taking part in the study.
Where is the study run from?
TYPPEX WP3d is running in Improving Access to Psychological Therapies services in three NHS mental health Trusts in England: Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), Norfolk and Suffolk NHS Foundation Trust (NSFT) and Sussex Partnership Foundation Trust (SPFT). CPFT is co-sponsor with University of Cambridge and is the lead site.
When is the study starting and how long is it expected to run for?
It will begin in April 2019 and recruitment will close in October 2019.
Who is funding the study?
It is funded by a Programme Grant for Applied Research (PGfAR) NIHR grant.
Who is the main contact?
Clare Knight, ck462@medschl.cam.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Ms Clare Knight
ORCID ID
Contact details
Herchel Smith Building
Robinson Way
Cambridge
CB2 0SZ
Cambridge
CB2 0SZ
United Kingdom
01223 337106
ck462@medschl.cam.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
v1
Study information
Scientific title
Addressing common mental disorder and psychotic experiences: a feasibility and preliminary effectiveness study of a training package for Step 3 CBT therapists in Improving Access to Psychological Therapies (IAPT) services.
Acronym
TYPPEX WP3d
Study hypothesis
Providing CBT therapists with training to enhance existing CBT skills to allow them to work more effectively with people with common mental disorder and psychotic experiences will improve Reliable Recovery rates for these patients in IAPT services
Ethics approval
Approved 20/03/2019, South Central Berkshire REC (Bristol HRA Centre, Level 3, Block B, Whitefriars, Lewins Mead, Bristol BS1 2NT; nrescommittee.southcentral-berkshire@nhs.net; 0207 1048043), ref: 19/SC/0077
Study design
Single arm non-blinded interventional feasibility study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web for,at, please use contact details to request a participant information sheet
Condition
Mental health
Intervention
Step 3 Cognitive Behavioural Therapy (CBT) training for therapists treating people experiencing common mental disorder with psychotic symptoms.
The structured training programme includes:
Module 1: Background to the TYPPEX programme and psychotic experiences in the IAPT population.
Module 2: Assessment and formulation of common mental disorder with psychotic experiences.
Module 3: Interventions
Training is delivered across 3 days and is supported by 6 supervision sessions.
This feasibility study will train 8-10 therapists in each of three teams within the IAPT service (one team per mental health Trust). The training package will support therapists to deliver care to service users with psychotic experiences and common mental disorder; people who have scored above a threshold on the Community Assessment of Psychic Experiences (CAPE) questionnaire, referred to as CAPE+. Following training, therapists will treat an average of 3 CAPE+ service users each.
A total of 45 CAPE+ service users will be asked to consent to the collection of health economic data via online questionnaires at baseline (therapy session 2), then at 3 months and 6 months after that. Routine clinical data for all CAPE+ service users will be provided by the Trusts to the Norwich Clinical Trials Unit in an anonymised form.
In this feasibility study, we will assess the viability of recruiting, training and supervising therapists, and their use of TYPPEX strategies. The most feasible and effective methods of collecting health economic data from service users will be assessed. Clinical and health economic data collected in the feasibility study will inform the design of the TYPPEX randomised controlled trial, which will test the hypothesis that care delivered to CAPE+ IAPT users by TYPPEX-trained therapists will be more effective and cost-effective than treatment-as-usual in IAPT services.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Reliable Recovery proportion rate for people with psychotic experiences (the proportion of service users reaching scores below 10 in PHQ-9 and 8 in GAD-7) measured via scores on the routinely collected PHQ-9 and GAD-7 and additionally at 24 weeks post-therapy commencement.
Secondary outcome measures
1. Feasibility of collecting health economics data via the EQ-5D and Adult Service Use Schedule to inform definitive RCT
2. Recruitment rate of consented CAPE+ IAPT users for health economic data collection
3. Assessment of the most feasible and effective methods of collecting health economic data
4. Feasibility of using an adapted version of the Early Intervention in Psychosis Adult Service Use Schedule (EI-ADSUS) with the IAPT patient population
Overall trial start date
01/04/2019
Overall trial end date
31/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. IAPT therapist - Training inclusion criteria:
1.1 Qualified Step 3 IAPT therapist.
1.2 Willing and able to participate in TYPPEX training and supervision.
2. IAPT User - pseudonymised clinical data collection inclusion criteria:
2.1 Accepted onto the IAPT caseload for therapy and therefore meet service specific inclusion criteria to access IAPT treatment,
2.2 Meet current criteria for IAPT Step 3 treatment,
2.3 Presence of psychotic experiences, according to CAPE-P15 cut-off values of 1.47 on both the frequency and distress sub-scales.
3. IAPT User - Health economic questionnaires inclusion criteria
3.1 Meets IAPT User Eligibility Criteria for pseudonymised clinical data collection
3.2 In the judgement of the treating therapist has sufficient proficiency in English to complete research questionnaires.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant exclusion criteria
1. IAPT Therapist - Training exclusion criteria:
1.1 Has not completed Step 3 High Intensity IAPT training.
1.2 Works across more than one locality IAPT team.
2. IAPT User - pseudonymised clinical data collection exclusion criteria
2.1 Presence of mental disorder based on standard IAPT assessment meriting routine referral to NICE step 4 treatment, i.e. to secondary mental health services.
3. IAPT User Health Economic Questionnaires exclusion criteria:
3.1 None
Recruitment start date
04/04/2019
Recruitment end date
31/10/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House, Fulbourn Hospital
Cambridge
Cambridgeshire
CB21 5EF
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We intend to publish the trial protocol in April 2019 and results of the feasibility study in January 2020 in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
31/01/2023
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list