An interventional study of Cognitive Analytic Therapy - Guided Self Help (CAT-GSH) in Depression, sponsored by University of Sheffield. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by University of Sheffield · Not applicable, Interventional, and Treatment
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.
Aims Phase One
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:
The exclusion criteria will be:
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 13 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Sheffield is the lead sponsor of 74 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Participants, who provide informed consent, will be provided an assessment session, six fortnightly CAT-GSH sessions, and one follow-up session.
Other: Cognitive Analytic Therapy - Guided Self Help (CAT-GSH)
CAT-GSH is a novel intervention designed to help those with depression by focusing on the relationships within their life. GSH is used in step two of IAPT services and is typically six fortnightly sessions where the PWP helps the service user complete the self help manual.
Patient Health Questionnaire - PHQ9
The PHQ9 is a 9-item self-administered questionnaire designed for detecting depression and is based on the DSM-IV criteria.
Time frame: Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.
Generalised Anxiety Disorder Assessment - GAD 7
The GAD7 is also widely used within primary care settings and is a self-reported screening tool for generalised anxiety disorder.
Time frame: Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.
Work and Social Adjustment Scale - WSAS
This scale measures social functioning.
Time frame: Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.
Plan to share: Yes — Only anonymized data will be shared. Personal data will not be.
Supporting information: Study protocol
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