AnxietyNCT06806176
Effectiveness of CAT-GSH for Returning Patients
A study testing Cognitive analytic therapy guided self-help (CAT-GSH) and Cognitive behavioural therapy guided self-help (CBT-GSH) in people with Anxiety and Depression, run by University of Sheffield at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Cognitive analytic therapy guided self-help (CAT-GSH) and Cognitive behavioural therapy guided self-help (CBT-GSH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Tameside and Glossop NHS Talking Therapies Service
Ashton-under-Lyne, OL6 7SR
Jessica Lancashire, +44161 716 4242, jessica.lancashire@nhs.net
Jessica Lancashire
- Recruiting
Leeds Mental Wellbeing Service
Leeds, LS9 7TA
Ruby Warren, +44113 843 4388, ruby.warren@nhs.net
Ruby Warren
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Cognitive analytic therapy guided self-help (CAT-GSH), Cognitive behavioural therapy guided self-help (CBT-GSH)
- Keywords
- Cognitive analytic therapy (CAT), Guided self-help, NHS Talking Therapies, returning patients, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive analytic therapy guided self-help (CAT-GSH)Behavioural
Six session CAT-GSH treatment
Cognitive behavioural therapy guided self-help (CBT-GSH)Behavioural
Six session CBT-GSH treatment
| Study group | Role | What they receive |
|---|---|---|
| CBT-GSH arm | Active comparator | CBT-GSH group Receives: Behavioral: Cognitive behavioural therapy guided self-help (CBT-GSH) |
| CAT-GSH arm | Active comparator | CAT-GSH group Receives: Behavioral: Cognitive analytic therapy guided self-help (CAT-GSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Measured: From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start30 Jul 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will have a choice between CBT guided self-help and CAT guided self-help.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Catalyse CAT Limited, Tameside and Glossop Talking Therapies service, Leeds Mental Wellbeing service
- Responsible party
- Sponsor
- Investigators
- Andrew J Laphan, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806176
- Sponsor's protocol ID
- 191606
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymized data will be shared. Personal data will not be.
Publications
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.
PubMed 26768890Wakefield 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.
PubMed 33458855Simmonds-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.
PubMed 35914380Owen 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.
PubMed 37317047Meadows 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.
PubMed 28325165Lorimer 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.
PubMed 37563726Kellett 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.
PubMed 33483113Hallam 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.
PubMed 32543107Bohnke 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.
PubMed 25012441Wray 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.
PubMed 35575218Kellett 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.
PubMed 37395600
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Acceptability of Cognitive Analytic Therapy Guided Self-help (CAT-GSH) for Anxiety and Depression for Returning Patients in NHS Talking Therapies Services
- ClinicalTrials.gov ID
- NCT06806176
- Acronym / sponsor ID
- 191606
- Conditions
- Anxiety, Depression
- Keywords
- Cognitive analytic therapy (CAT), Guided self-help, NHS Talking Therapies, returning patients, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Catalyse CAT Limited, Tameside and Glossop Talking Therapies service, Leeds Mental Wellbeing service
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will have a choice between CBT guided self-help and CAT guided self-help.
| Arm | Type | Receives |
|---|---|---|
| CBT-GSH arm | Active comparator | Behavioral: Cognitive behavioural therapy guided self-help (CBT-GSH)CBT-GSH group |
| CAT-GSH arm | Active comparator | Behavioral: Cognitive analytic therapy guided self-help (CAT-GSH)CAT-GSH group |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive analytic therapy guided self-help (CAT-GSH)Six session CAT-GSH treatment | Behavioural | CAT-GSH arm |
| Cognitive behavioural therapy guided self-help (CBT-GSH)Six session CBT-GSH treatment | Behavioural | CBT-GSH arm |
Primary outcome
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.
2 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 26768890Williams 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.
- Background: PubMed 33458855Wakefield 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.
- Background: PubMed 35914380Simmonds-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.
- Background: PubMed 37317047Owen 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.
- Background: PubMed 28325165Meadows 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.
- Background: PubMed 37563726Lorimer 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.
- Background: PubMed 33483113Kellett 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.
- Background: PubMed 32543107Hallam 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.
- Background: PubMed 25012441Bohnke 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.
- Background: PubMed 35575218Wray 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.
- Background: PubMed 37395600Kellett 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.
- Individual participant dataSharing planned: Yes. Only anonymized data will be shared. Personal data will not be.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew J Laphan principal investigator
University of Sheffield
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive analytic therapy guided self-help (CAT-GSH) and Cognitive behavioural therapy guided self-help (CBT-GSH) in people with Anxiety and Depression, run by University of Sheffield at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Laphan (01142226650, alaphan1@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806176, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.