An interventional study of Cognitive analytic therapy guided self-help (CAT-GSH) and Cognitive behavioural therapy guided self-help (CBT-GSH) in Anxiety and Depression, sponsored by University of Sheffield. Recruiting at 2 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by University of Sheffield · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if cognitive analytic therapy-guided self-help (CAT-GSH) is comparable to cognitive behavioural therapy-guided self-help (CBT-GSH) in terms of whether it is effective and acceptable for people with anxiety or low mood, who are returning to NHS Talking Therapy services for further treatment. The main questions it aims to answer are:
Participants will:
A prospective quantitative, quasi-experimental design will be used to address the primary and secondary questions. PWPs will be trained in delivering CAT-GSH. Participants will choose between CAT-GSH and CBT-GSH and be offered a six-session contact of one-to-one GSH. The Talking Therapies service already collects routine outcome measures, which will be collated and analysed.
Procedure/Intervention The Talking Therapies services routinely perform an initial assessment when someone is referred to their services. Potential participants who meet the inclusion criteria will be identified at the assessment stage.
Tameside and Glossop Talking Therapies service procedure:
The assessor will ask if there is potential interest in a study using a screening script; if the person remains interested, the participant information sheet (PIS) and the consent form will be emailed or posted. At least 48 hours will be left to allow the participant to read the information.
The principal investigator will give a follow-up phone call to answer any potential questions, ask for preference on the therapy, and complete the consent form, which will be emailed or posted back to the Talking Therapies service once completed. The completed consent form will be saved in the site's local file and a copy of the form will be sent to the participant. If the person no longer wants to participate at this stage, the service user will receive the treatment as usual.
Leeds Mental Wellbeing Service procedure:
The assessor will ask if there is potential interest in a study using a screening script; if the person remains interested, the potential participant information sheet (PIS) and the consent form will be emailed or posted. The potential participant will be given 7 days to read the information, email the Leeds service with their preferred treatment, and return the signed consent form to the service if the potential participant does not request further information. 14 days will be given if the participant asks for the material to be posted. If the potential participant requests further information, the clinical lead and principal investigator will contact the potential participant to discuss this. The completed consent form will be saved in the site's local file and a copy will be sent to the participant. If the person no longer wants to participate at this stage or has not emailed within 7 days or returned the forms by post within 14 days, the service user will receive the treatment as usual, so there are no delays.
All services procedure:
The Talking Therapies services collect routine outcome measures, demographics and other data as standard. Sessions can take place face-to-face, online, or by telephone. The sessions last 35 minutes, for a total of six sessions. Sessions are carried out weekly or bi-weekly.
The psychological wellbeing practitioner (PWP) will record the third session with the participant, so the research team can perform a randomly selected competency check on the CBT-GSH and CAT-GSH delivered to service users. The recording will be sent to the research team, with no personally identifiable information on the file name. However, due to the nature of recordings, they may contain identifiable information. Participants will be made aware of this in the PIS.
The analysis stage will aim to start in December 2025, to explore the outcome measure data.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 100 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Individuals who are not fluent in English will be excluded from the study due to not having translated CAT-GSH workbooks available and limited funding to translate any workbooks.
CBT-GSH group
Behavioral: Cognitive behavioural therapy guided self-help (CBT-GSH)
CAT-GSH group
Behavioral: Cognitive analytic therapy guided self-help (CAT-GSH)
Six session CAT-GSH treatment
Six session CBT-GSH treatment
Composite score (Generalised Anxiety Disorder-7 (GAD-7), Patient health Questionaire-9 (PHQ-9) and Work and Social Adjustment Scale (WSAS))
Routine outcome measures, Generalised Anxiety Disorder-7 (GAD-7), Patient Health Questionaire-9 (PHQ-9) and Work and Social Adjustment Scale (WSAS) collected before, during and after treatment will be combined into composite scores.
Time frame: From enrolment to the end of treatment after 6 sessions, weekly or bi-weekly. 6-12 weeks.
Patient Health Questionnaire (PHQ-9)
Routine outcome measure, collected as part of normal treatment at the NHS Talking Therapy site - Patient Health Questionnaire-9 (PHQ-9). Collected before, during and after treatment. The PHQ-9 uses a 9-item scale with a total severity score of 0-27. Higher scores indicate greater depression and the clinical cut-off point indicating significant depression is ≥10.
Time frame: From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.
Generalised Anxiety Disorder (GAD-7)
Routine outcome measure, collected as part of normal treatment at the NHS Talking Therapy site - Generalised Anxiety Disorder-7 (GAD-7). Collected before, during and after treatment. The GAD-7 uses a 7-item scale with a total severity score ranging from 0 to 21. Higher scores indicate greater anxiety and the clinical cut-off indicating significant anxiety is ≥8
Time frame: From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.
Plan to share: Yes — Only anonymized data will be shared. Personal data will not be.
Supporting information: Study protocol
Time frame: At the end of the study (approximately May 2026), data will be stored on the University of Sheffield's ORDA (online research hub) for 10 years according to the University of Sheffield's retention period.
Access criteria: Information can be requested through ORDA by those who qualify for membership.
Started Jul 2025 (actual). Primary completion is estimated for Dec 2025, 5 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 5 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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