Effectiveness of CAT-GSH for Returning Patients

NCT06806176 | Recruiting

• 1 other identifier: 191606
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Anxiety; Depression

Keywords

Cognitive analytic therapy (CAT); Guided self-help; NHS Talking Therapies; returning patients; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrolment to the end of treatment after 6 sessions, weekly or bi-weekly. 6-12 weeks.

Secondary Outcomes (2)

• Patient Health Questionnaire (PHQ-9)

  From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.

• Generalised Anxiety Disorder (GAD-7)

  From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.

Study Arms (2)

CBT-GSH arm

ACTIVE COMPARATOR

CBT-GSH group

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

CAT-GSH arm

ACTIVE COMPARATOR

CAT-GSH group

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

Interventions

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

Six session CAT-GSH treatment

CAT-GSH arm

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

Six session CBT-GSH treatment

CBT-GSH arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sheffield: lead
• Catalyse CAT Limited: collaborator
• Tameside and Glossop Talking Therapies service: collaborator
• Leeds Mental Wellbeing service: collaborator

Study Sites (2)

Tameside and Glossop NHS Talking Therapies Service

Ashton-under-Lyne, OL6 7SR, United Kingdom

RECRUITING

Leeds Mental Wellbeing Service

Leeds, LS9 7TA, United Kingdom

RECRUITING

Related Publications (11)

• 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.

  PMID: 26768890 BACKGROUND

• 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.

  PMID: 33458855 BACKGROUND

• 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.

  PMID: 35914380 BACKGROUND

• 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.

  PMID: 37317047 BACKGROUND

• 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.

  PMID: 28325165 BACKGROUND

• 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.

  PMID: 37563726 BACKGROUND

• 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.

  PMID: 33483113 BACKGROUND

• 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.

  PMID: 32543107 BACKGROUND

• 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.

  PMID: 25012441 BACKGROUND

• 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.

  PMID: 35575218 BACKGROUND

• 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.

  PMID: 37395600 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andrew J Laphan

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Laphan

CONTACT

01142226650; alaphan1@sheffield.ac.uk

Amrit Sinha

CONTACT

01142226650; a.sinha@sheffield.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will have a choice between CBT guided self-help and CAT guided self-help.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 3, 2025
• Study Start: July 30, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

GB (2)