AnxietyNCT03730532
Guided Self-help for Anxiety - a Patient Preference Trial
A study testing Cognitive Behavioural Therapy Guided Self Help and Cognitive Analytic Therapy Guided Self Help in people with Anxiety, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
Supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. In Improving Access to Psychological Therapies (IAPT) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (GSH), when they are deemed suitable for… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Cognitive Behavioural Therapy Guided Self Help and Cognitive Analytic Therapy Guided Self Help
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients have self-referred or been referred by their GP or other health or social care professional for a step 2 intervention for treatment of a common mental health problem,
- patients meet criteria for an anxiety disorder on MINI screening interview assessment and also met caseness on the BAI (as defined by a score of >10 on the BAI at assessment).
- Patients want to engage in GSH to address the anxiety disorder
- patients are motivated to engage in treatment and can attend six sessions of face-to-face GSH.
Who cannot join
- engaging in any another IAPT step 2 interventions.
- Do not meet criteria for an anxiety disorder as defined by the MINI and the BAI score.
- Meet criteria for depression and a comorbid anxiety disorder, as identified by the BAI and MINI, where the depression is more severe and is the patient's main concern.
- Have a severe/chronic mental health problem and are already involved in psychiatric or secondary care mental health services.
- Have substance misuse issues that would interfere with engagement with the GSH.
- Have a diagnosed learning disability that precludes engagement in GSH.
- Have a diagnosis of social phobia or PTSD
Trial locations and contacts
1 site in 1 country.
Emma Beattie-Edwards contact
United Kingdom1 site, 1 recruiting
- Recruiting
Oldham Healthy Minds IAPT
Oldham, Lancashire, OL11RU
Charlotte Bee, 0161 7162777, charlotte.bee2@nhs.net
About this study
Official title: Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial
Supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. In Improving Access to Psychological Therapies (IAPT) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (GSH), when they are deemed suitable for treatment at step 2 of IAPT services (termed CBT-GSH). Step 2 interventions are guided self-help (GSH) delivered by Psychological Wellbeing Practitioners (PWPs). Recently, a new type of GSH has been developed and found to be feasible and effective in IAPT services - this is called cognitive-analytic guided self-help (CAT-GSH). This research aims to test the efficacy of CAT-GSH by comparing outcomes over time achieved in both types of GSH and interviewing participants about their experience of the GSH. The methodology to support patient choice is a patient preference trial. In this method, then patients that meet inclusion criteria for the trial are offered and choose between either CAT-GSH and CBT-GSH. Those patients that are unconcerned with the type of treatment are randomised to either CAT-GSH or CBT-GSH. The primary outcome measure is the Beck Anxiety Inventory. No changes to the standard practice of the PWPs will occur during the trial, the trial will be situated in a standard IAPT service and be a therefore conducted in a routine practice setting.
- Conditions
- Anxiety
- Being tested
- Cognitive Behavioural Therapy Guided Self Help, Cognitive Analytic Therapy Guided Self Help
- Keywords
- Guided self help, Cognitive Analytic Therapy, Cognitive Behavioral Therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy Guided Self HelpOther
6-week manualised Cognitive Behavioural Therapy Guided Self Help
Cognitive Analytic Therapy Guided Self HelpOther
6-week manualised Cognitive Analytic Therapy Guided Self Help
| Study group | Role | What they receive |
|---|---|---|
| Randomised CBT | Experimental | Cognitive Behavioural Therapy Guided Self Help Receives: Other: Cognitive Behavioural Therapy Guided Self Help |
| Randomised CAT | Experimental | Cognitive Analytic Therapy Guided Self Help Receives: Other: Cognitive Analytic Therapy Guided Self Help |
| Preference CAT | Experimental | Cognitive Analytic Therapy Guided Self Help Receives: Other: Cognitive Analytic Therapy Guided Self Help |
| Preference CBT | Experimental | Cognitive Behavioural Therapy Guided Self Help Receives: Other: Cognitive Behavioural Therapy Guided Self Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
measuring change in anxiety at four time points
Measured: Measured at screening, at 6 weeks, 12 weeks and 24 weeks
Secondary outcomes (2)
Generalised Anxiety Disorder - 7
measuring change in anxiety across the intervention and follow-up
Measured: Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
patient health questionnaire - 9
measuring change in depression across the intervention and follow-up
Measured: Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start29 Jan 2019
- Primary completionJul 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient Preference Trial
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Beattie-Edwards, University of Sheffield
- Investigators
- Steve Kellett, Study director, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730532
- Sponsor's protocol ID
- 240751
- Status last verified
- Feb 2019
- First submitted
- 16 Oct 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37395600
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial
- ClinicalTrials.gov ID
- NCT03730532
- Acronym / sponsor ID
- 240751
- Conditions
- Anxiety
- Keywords
- Guided self help, Cognitive Analytic Therapy, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 5 Nov 2018 (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.
Supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. In Improving Access to Psychological Therapies (IAPT) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (GSH), when they are deemed suitable for treatment at step 2 of IAPT services (termed CBT-GSH). Step 2 interventions are guided self-help (GSH) delivered by Psychological Wellbeing Practitioners (PWPs). Recently, a new type of GSH has been developed and found to be feasible and effective in IAPT services - this is called cognitive-analytic guided self-help (CAT-GSH). This research aims to test the efficacy of CAT-GSH by comparing outcomes over time achieved in both types of GSH and interviewing participants about their experience of the GSH. The methodology to support patient choice is a patient preference trial. In this method, then patients that meet inclusion criteria for the trial are offered and choose between either CAT-GSH and CBT-GSH. Those patients that are unconcerned with the type of treatment are randomised to either CAT-GSH or CBT-GSH. The primary outcome measure is the Beck Anxiety Inventory. No changes to the standard practice of the PWPs will occur during the trial, the trial will be situated in a standard IAPT service and be a therefore conducted in a routine practice setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patient Preference Trial
| Arm | Type | Receives |
|---|---|---|
| Randomised CBT | Experimental | Other: Cognitive Behavioural Therapy Guided Self HelpCognitive Behavioural Therapy Guided Self Help |
| Randomised CAT | Experimental | Other: Cognitive Analytic Therapy Guided Self HelpCognitive Analytic Therapy Guided Self Help |
| Preference CAT | Experimental | Other: Cognitive Analytic Therapy Guided Self HelpCognitive Analytic Therapy Guided Self Help |
| Preference CBT | Experimental | Other: Cognitive Behavioural Therapy Guided Self HelpCognitive Behavioural Therapy Guided Self Help |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients have self-referred or been referred by their GP or other health or social care professional for a step 2 intervention for treatment of a common mental health problem,
- patients meet criteria for an anxiety disorder on MINI screening interview assessment and also met caseness on the BAI (as defined by a score of >10 on the BAI at assessment).
- Patients want to engage in GSH to address the anxiety disorder
- patients are motivated to engage in treatment and can attend six sessions of face-to-face GSH.
Key exclusion criteria (7 listed)
- engaging in any another IAPT step 2 interventions.
- Do not meet criteria for an anxiety disorder as defined by the MINI and the BAI score.
- Meet criteria for depression and a comorbid anxiety disorder, as identified by the BAI and MINI, where the depression is more severe and is the patient's main concern.
- Have a severe/chronic mental health problem and are already involved in psychiatric or secondary care mental health services.
- Have substance misuse issues that would interfere with engagement with the GSH.
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 Behavioural Therapy Guided Self Help6-week manualised Cognitive Behavioural Therapy Guided Self Help | Other | Preference CBT, Randomised CBT |
| Cognitive Analytic Therapy Guided Self Help6-week manualised Cognitive Analytic Therapy Guided Self Help | Other | Preference CAT, Randomised CAT |
Primary outcome
Beck Anxiety Inventory
Time frame: Measured at screening, at 6 weeks, 12 weeks and 24 weeks
measuring change in anxiety at four time points
2 secondary outcomes
Generalised Anxiety Disorder - 7
Time frame: Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
patient health questionnaire - 9
Time frame: Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: 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: No
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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. This study is not recruiting at the moment.
Emma Beattie-Edwards contact
Steve Kellett study director
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy Guided Self Help and Cognitive Analytic Therapy Guided Self Help in people with Anxiety, run by University of Sheffield at 1 site 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Kellett (+44114 222 6537, s.kellett@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (time frame: Measured at screening, at 6 weeks, 12 weeks and 24 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 NCT03730532, which also lists 1 linked publication.
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 5 Feb 2019.