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

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 Overview

• Status: Unknown
• Conditions: Anxiety
• Intervention / Treatment: Other: Cognitive Behavioural Therapy Guided Self Help; Other: Cognitive Analytic Therapy Guided Self Help

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Oldham, Lancashire, United Kingdom, OL11RU
      • Recruiting
      • Oldham Healthy Minds IAPT
      • Contact: Charlotte Bee; Phone Number: 0161 7162777; Email: charlotte.bee2@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sheffield
• Investigators: Study Director: Steve Kellett, University of Sheffield

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Guided self help; Cognitive Analytic Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 240751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No