Guided Self-help for Anxiety - a Patient Preference Trial

Not Applicable

• Conditions: Anxiety

• Registration Number: NCT03730532
• Lead Sponsor: University of Sheffield

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Study Start: 2019-01-29
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05
• Primary Completion: 2020-07
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory	Measured at screening, at 6 weeks, 12 weeks and 24 weeks	measuring change in anxiety at four time points

Secondary Outcome Measures

Name	Time	Method
Generalised Anxiety Disorder - 7	Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up	measuring change in anxiety across the intervention and follow-up
patient health questionnaire - 9	Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up	measuring change in depression across the intervention and follow-up

Trial Locations

Locations (1)

Oldham Healthy Minds IAPT; 🇬🇧 Oldham, Lancashire, United Kingdom