Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05344326 |
| Other study ID # |
175377 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 7, 2022 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
University of Sheffield |
| Contact |
Rebecca Kelly |
| Phone |
01142226650 |
| Email |
rkelly2[@]sheffield.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cognitive analytic therapy (CAT) is used within mental health services as a treatment for a
range of mental health difficulties. Recent research has adapted CAT to be used as guided
self-help for anxiety within Increasing Access to Psychological Therapies (IAPT). IAPT is a
mental health service. Guided self help-CAT (CAT-GSH) is delivered by mental health
professionals called Psychological Wellbeing Practitioners (PWPs). This current study aims to
develop and pilot a CAT-GSH manual for depression for use in the same context and
practitioners. Stage one uses past research and consultation meetings to help develop the
treatment. Stage two will use different approaches to explore the acceptability and outcomes
of the intervention.
Description:
Aims Phase One
1) Develop a CAT-informed GSH manual (CAT-GSH) for depression Phase Two
1. Pilot CAT-SH within IAPT setting
2. To explore the impact of CAT-GSH on outcomes
3. To investigate the acceptability of CAT-GSH
Method Stage One Past research and consultation meetings will be consolidated into a matrix.
This will inform the development of the treatment manual.
Stage Two A mixed-methods, small N case series design will be utilized to pilot the CAT-GSH
manual within IAPT services. Three Psychological Wellbeing Practitioners (PWP) and 10 service
users will be recruited from Barnsley IAPT service. The PWPs will be provided a two-day
training course before the study begins. This will cover information regarding the CAT-GSH,
data management, and the protocol. To recruit 10 service user participants, it is predicted
the first 60 people on the Barnsley IAPT waiting list would need to be screened to account
for eligibility criteria, preference, and attrition.
Participants will be offered to complete CAT-GSH if:
1. Depression is the main problem
2. They score above the clinical cut off (10 points) on the Patient Health Questionnaire
(PHQ9; Kroenke and Spitzer, 2002)
3. Aged between 18 - 65
4. Would prefer to use CAT-GSH over other interventions
5. Consent to participate in study
6. Can engage with reading materials
The exclusion criteria will be:
1. Patients who would normally be 'stepped up' due to complexity and risk
2. Patients are receiving other therapies
3. Substance users unable to abstain during sessions The exclusion criteria are in line
with IAPT step-two treatment guidance and support.
The participants will be invited to an assessment session where they will be informed about
the research, be provided with information sheets and consent sheets. The participants will
have time to contact the researchers if they have any questions about the research.
If they provide informed consent, they will be provided with six, fortnightly CAT-GSH
sessions facilitated by the PWPs. In these sessions, they will also complete three outcome
measures. The patient health questionnaire, the generalized anxiety disorder assessment, and
the work and social adjustment scale.
They will receive a follow-up session, with the PWP, where they will also complete the
outcome measures and review their care. They will also arrange an interview with the primary
research to explore their experiences of CAT-GSH. This will follow an interview schedule. The
PWPs will also attend a separate, PWP group interview where they will also reflect on their
experiences of delivering GSH. This will be provided by the researcher.
The analysis stage of the process will then begin as the researchers explore the outcome
measure data and the interview data.
