Guided Self-help for Anxiety - a Patient Preference Trial
Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial
1 other identifier
interventional
134
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Jan 2019
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 5, 2018
CompletedStudy Start
First participant enrolled
January 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFebruary 5, 2019
February 1, 2019
1.4 years
October 16, 2018
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beck Anxiety Inventory
measuring change in anxiety at four time points
Measured at screening, at 6 weeks, 12 weeks and 24 weeks
Secondary Outcomes (2)
Generalised Anxiety Disorder - 7
Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
patient health questionnaire - 9
Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
Study Arms (4)
Randomised CBT
EXPERIMENTALCognitive Behavioural Therapy Guided Self Help
Randomised CAT
EXPERIMENTALCognitive Analytic Therapy Guided Self Help
Preference CAT
EXPERIMENTALCognitive Analytic Therapy Guided Self Help
Preference CBT
EXPERIMENTALCognitive Behavioural Therapy Guided Self Help
Interventions
6-week manualised Cognitive Behavioural Therapy Guided Self Help
6-week manualised Cognitive Analytic Therapy Guided Self Help
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oldham Healthy Minds IAPT
Oldham, Lancashire, OL11RU, United Kingdom
Related Publications (1)
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: 37395600DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steve Kellett
University of Sheffield
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Trainee Clinical Psychologist
Study Record Dates
First Submitted
October 16, 2018
First Posted
November 5, 2018
Study Start
January 29, 2019
Primary Completion
July 1, 2020
Study Completion
September 1, 2020
Last Updated
February 5, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share