Guided Self-help for Anxiety - a Patient Preference Trial

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730532
• Other study ID #: 240751
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: September 2020

Study information

• Verified date: February 2019
• Source: University of Sheffield
• Contact: Steve Kellett
• Phone: +44114 222 6537
• Email: s.kellett[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Cognitive Behavioural Therapy Guided Self Help
6-week manualised Cognitive Behavioural Therapy Guided Self Help
• Cognitive Analytic Therapy Guided Self Help
6-week manualised Cognitive Analytic Therapy Guided Self Help

Locations

Country	Name	City	State
United Kingdom	Oldham Healthy Minds IAPT	Oldham	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Anxiety Inventory	measuring change in anxiety at four time points	Measured at screening, at 6 weeks, 12 weeks and 24 weeks
Secondary	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
Secondary	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