Effectiveness of CAT-GSH for Returning Patients

NCT ID: NCT06806176

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will have a choice between CBT guided self-help and CAT guided self-help.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBT-GSH arm

CBT-GSH group

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy guided self-help (CBT-GSH)

Intervention Type BEHAVIORAL

Six session CBT-GSH treatment

CAT-GSH arm

CAT-GSH group

Group Type ACTIVE_COMPARATOR

Cognitive analytic therapy guided self-help (CAT-GSH)

Intervention Type BEHAVIORAL

Six session CAT-GSH treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive analytic therapy guided self-help (CAT-GSH)

Six session CAT-GSH treatment

Intervention Type BEHAVIORAL

Cognitive behavioural therapy guided self-help (CBT-GSH)

Six session CBT-GSH treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catalyse CAT Limited

UNKNOWN

Sponsor Role collaborator

Tameside and Glossop Talking Therapies service

UNKNOWN

Sponsor Role collaborator

Leeds Mental Wellbeing service

UNKNOWN

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew J Laphan

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tameside and Glossop NHS Talking Therapies Service

Ashton-under-Lyne, , United Kingdom

Site Status RECRUITING

Leeds Mental Wellbeing Service

Leeds, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrew J Laphan

Role: CONTACT

01142226650

Amrit Sinha

Role: CONTACT

01142226650

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jessica Lancashire

Role: primary

+44161 716 4242

Ruby Warren

Role: primary

+44113 843 4388

References

Explore related publications, articles, or registry entries linked to this study.

Williams R, Farquharson L, Palmer L, Bassett P, Clarke J, Clark DM, Crawford MJ. Patient preference in psychological treatment and associations with self-reported outcome: national cross-sectional survey in England and Wales. BMC Psychiatry. 2016 Jan 15;16:4. doi: 10.1186/s12888-015-0702-8.

Reference Type BACKGROUND
PMID: 26768890 (View on PubMed)

Wakefield S, Delgadillo J, Kellett S, White S, Hepple J. The effectiveness of brief cognitive analytic therapy for anxiety and depression: A quasi-experimental case-control study. Br J Clin Psychol. 2021 Jun;60(2):194-211. doi: 10.1111/bjc.12278. Epub 2021 Jan 17.

Reference Type BACKGROUND
PMID: 33458855 (View on PubMed)

Simmonds-Buckley M, Osivwemu EO, Kellett S, Taylor C. The acceptability of cognitive analytic therapy (CAT): Meta-analysis and benchmarking of treatment refusal and treatment dropout rates. Clin Psychol Rev. 2022 Aug;96:102187. doi: 10.1016/j.cpr.2022.102187. Epub 2022 Jul 18.

Reference Type BACKGROUND
PMID: 35914380 (View on PubMed)

Owen K, Laphan A, Gee B, Lince K. Evaluating cognitive analytic therapy within a primary care psychological therapy service. Br J Clin Psychol. 2023 Sep;62(3):663-673. doi: 10.1111/bjc.12430. Epub 2023 Jun 14.

Reference Type BACKGROUND
PMID: 37317047 (View on PubMed)

Meadows J, Kellett S. Development and Evaluation of Cognitive Analytic Guided Self-Help (CAT-SH) for Use in IAPT Services. Behav Cogn Psychother. 2017 May;45(3):266-284. doi: 10.1017/S1352465816000485. Epub 2017 Mar 22.

Reference Type BACKGROUND
PMID: 28325165 (View on PubMed)

Lorimer B, Kellett S, Giesemann J, Lutz W, Delgadillo J. An investigation of treatment return after psychological therapy for depression and anxiety. Behav Cogn Psychother. 2024 Mar;52(2):149-162. doi: 10.1017/S1352465823000322. Epub 2023 Aug 11.

Reference Type BACKGROUND
PMID: 37563726 (View on PubMed)

Kellett S, Simmonds-Buckley M, Limon E, Hague J, Hughes L, Stride C, Millings A. Defining the Assessment and Treatment Competencies to Deliver Low-Intensity Cognitive Behavior Therapy: A Multi-Center Validation Study. Behav Ther. 2021 Jan;52(1):15-27. doi: 10.1016/j.beth.2020.01.006. Epub 2020 May 20.

Reference Type BACKGROUND
PMID: 33483113 (View on PubMed)

Hallam C, Simmonds-Buckley M, Kellett S, Greenhill B, Jones A. The acceptability, effectiveness, and durability of cognitive analytic therapy: Systematic review and meta-analysis. Psychol Psychother. 2021 Mar;94 Suppl 1:8-35. doi: 10.1111/papt.12286. Epub 2020 Jun 15.

Reference Type BACKGROUND
PMID: 32543107 (View on PubMed)

Bohnke JR, Lutz W, Delgadillo J. Negative affectivity as a transdiagnostic factor in patients with common mental disorders. J Affect Disord. 2014 Sep;166:270-8. doi: 10.1016/j.jad.2014.05.023. Epub 2014 May 27.

Reference Type BACKGROUND
PMID: 25012441 (View on PubMed)

Wray A, Kellett S, Bee C, Smithies J, Aadahl V, Simmonds-Buckley M, McElhatton C. The acceptability of cognitive analytic guided self-help in an Improving Access to Psychological Therapies service. Behav Cogn Psychother. 2022 Sep;50(5):493-507. doi: 10.1017/S1352465822000194. Epub 2022 May 16.

Reference Type BACKGROUND
PMID: 35575218 (View on PubMed)

Kellett S, Bee C, Smithies J, Aadahl V, Simmonds-Buckley M, Power N, Dugen-Williams C, Fallon N, Delgadillo J. Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial. Br J Psychiatry. 2023 Sep;223(3):438-445. doi: 10.1192/bjp.2023.78.

Reference Type BACKGROUND
PMID: 37395600 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

191606

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-Criticism Feasibility Study
NCT03215134 COMPLETED NA
Bounce-Back From Depression
NCT06832605 NOT_YET_RECRUITING NA
Treating Suicidality Remotely
NCT06370104 RECRUITING NA