Guided Self-help for Anxiety - a Patient Preference Trial

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial

Conditions
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Anxiety

Intervention / Treatment
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* Other: Cognitive Behavioural Therapy Guided Self Help
* Other: Cognitive Analytic Therapy Guided Self Help


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient Preference Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomised CBT<br>Cognitive Behavioural Therapy Guided Self Help | Other: Cognitive Behavioural Therapy Guided Self Help<br>* 6-week manualised Cognitive Behavioural Therapy Guided Self Help<br>|
| Experimental: Randomised CAT<br>Cognitive Analytic Therapy Guided Self Help | Other: Cognitive Analytic Therapy Guided Self Help<br>* 6-week manualised Cognitive Analytic Therapy Guided Self Help<br>|
| Experimental: Preference CAT<br>Cognitive Analytic Therapy Guided Self Help | Other: Cognitive Analytic Therapy Guided Self Help<br>* 6-week manualised Cognitive Analytic Therapy Guided Self Help<br>|
| Experimental: Preference CBT<br>Cognitive Behavioural Therapy Guided Self Help | Other: Cognitive Behavioural Therapy Guided Self Help<br>* 6-week manualised Cognitive Behavioural Therapy Guided Self Help<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory | measuring change in anxiety at four time points | Measured at screening, at 6 weeks, 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalised Anxiety Disorder - 7 | measuring change in anxiety across the intervention and follow-up | 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 at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided self help, Cognitive Analytic Therapy, Cognitive Behavioral Therapy