Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sheffield
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Beck Anxiety Inventory
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Randomised CBT
Cognitive Behavioural Therapy Guided Self Help
Intervention: Cognitive Behavioural Therapy Guided Self Help (Other)
Randomised CAT
Cognitive Analytic Therapy Guided Self Help
Intervention: Cognitive Analytic Therapy Guided Self Help (Other)
Preference CAT
Cognitive Analytic Therapy Guided Self Help
Intervention: Cognitive Analytic Therapy Guided Self Help (Other)
Preference CBT
Cognitive Behavioural Therapy Guided Self Help
Intervention: Cognitive Behavioural Therapy Guided Self Help (Other)
Outcomes
Primary Outcomes
Beck Anxiety Inventory
Time Frame: Measured at screening, at 6 weeks, 12 weeks and 24 weeks
measuring change in anxiety at four time points
Secondary Outcomes
- 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)
Investigators
Emma Beattie-Edwards
Trainee Clinical Psychologist
University of Sheffield