Effectiveness of CAT-GSH for Returning Patients

September 29, 2025 updated by: University of Sheffield

Effectiveness and Acceptability of Cognitive Analytic Therapy Guided Self-help (CAT-GSH) for Anxiety and Depression for Returning Patients in NHS Talking Therapies Services

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:

  • Does CAT-GSH work well and feel acceptable for people coming back to the Talking Therapies service, compared to CBT-GSH, when taking their characteristics (like age) into account
  • Does CAT-GSH work well and feel acceptable for people coming back to the Talking Therapies service, compared to those using CBT-GSH for the first time, when taking their characteristics (like age) into account?

Participants will:

  • Choose their preferred treatment
  • Complete 6 sessions of either CAT-GSH or CBT-GSH
  • Sessions will be weekly or bi-weekly
  • Complete routine outcome measures before, during and at the end of therapy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Ashton-under-Lyne, United Kingdom, OL6 7SR
        • Recruiting
        • Tameside and Glossop NHS Talking Therapies Service
        • Contact:
        • Principal Investigator:
          • Jessica Lancashire
      • Leeds, United Kingdom, LS9 7TA
        • Recruiting
        • Leeds Mental Wellbeing Service
        • Contact:
        • Principal Investigator:
          • Ruby Warren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Previously received CBT-GSH at same participating NHS Talking Therapies service
  • Presenting with anxiety or depression
  • Deemed suitable for step 2 low-intensity therapy, through assessment by a qualified PWP

Exclusion Criteria:

  • Previously received high-intensity therapy since receiving CBT-GSH
  • The previous treatment episode was in another NHS Talking Therapies service.
  • Not fluent in English

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-GSH arm
CBT-GSH group
Behavioral: Cognitive behavioural therapy guided self-help (CBT-GSH)
Six session CBT-GSH treatment
Active Comparator: CAT-GSH arm
CAT-GSH group
Behavioral: Cognitive analytic therapy guided self-help (CAT-GSH)
Six session CAT-GSH treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite score (Generalised Anxiety Disorder-7 (GAD-7), Patient health Questionaire-9 (PHQ-9) and Work and Social Adjustment Scale (WSAS))
Time Frame: From enrolment to the end of treatment after 6 sessions, weekly or bi-weekly. 6-12 weeks.
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.
From enrolment to the end of treatment after 6 sessions, weekly or bi-weekly. 6-12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.
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.
From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.
Generalised Anxiety Disorder (GAD-7)
Time Frame: From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.
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
From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sheffield

Collaborators

Catalyse CAT Limited
Tameside and Glossop Talking Therapies service
Leeds Mental Wellbeing service

Investigators

  • Principal Investigator: Andrew J Laphan, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only anonymized data will be shared. Personal data will not be.

IPD Sharing 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.

IPD Sharing Access Criteria

Information can be requested through ORDA by those who qualify for membership.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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