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Guided Self-help for Anxiety - a Patient Preference Trial

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy Guided Self Help
Cognitive Analytic Therapy Guided Self Help
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Guided self help, Cognitive Analytic Therapy, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oldham Healthy Minds IAPTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Randomised CBT

Randomised CAT

Preference CAT

Preference CBT

Arm Description

Cognitive Behavioural Therapy Guided Self Help

Cognitive Analytic Therapy Guided Self Help

Cognitive Analytic Therapy Guided Self Help

Cognitive Behavioural Therapy Guided Self Help

Outcomes

Primary Outcome Measures

Beck Anxiety Inventory
measuring change in anxiety at four time points

Secondary Outcome Measures

Generalised Anxiety Disorder - 7
measuring change in anxiety across the intervention and follow-up
patient health questionnaire - 9
measuring change in depression across the intervention and follow-up

Full Information

First Posted
October 16, 2018
Last Updated
February 1, 2019
Sponsor
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT03730532
Brief Title
Guided Self-help for Anxiety - a Patient Preference Trial
Official Title
Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Guided self help, Cognitive Analytic Therapy, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient Preference Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomised CBT
Arm Type
Experimental
Arm Description
Cognitive Behavioural Therapy Guided Self Help
Arm Title
Randomised CAT
Arm Type
Experimental
Arm Description
Cognitive Analytic Therapy Guided Self Help
Arm Title
Preference CAT
Arm Type
Experimental
Arm Description
Cognitive Analytic Therapy Guided Self Help
Arm Title
Preference CBT
Arm Type
Experimental
Arm Description
Cognitive Behavioural Therapy Guided Self Help
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioural Therapy Guided Self Help
Intervention Description
6-week manualised Cognitive Behavioural Therapy Guided Self Help
Intervention Type
Other
Intervention Name(s)
Cognitive Analytic Therapy Guided Self Help
Intervention Description
6-week manualised Cognitive Analytic Therapy Guided Self Help
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory
Description
measuring change in anxiety at four time points
Time Frame
Measured at screening, at 6 weeks, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Generalised Anxiety Disorder - 7
Description
measuring change in anxiety across the intervention and follow-up
Time Frame
Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up
Title
patient health questionnaire - 9
Description
measuring change in depression across the intervention and follow-up
Time Frame
Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Kellett
Phone
+44114 222 6537
Email
s.kellett@sheffield.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Beattie-Edwards
Email
ebeattieedwards1@sheffield.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Kellett
Organizational Affiliation
University of Sheffield
Official's Role
Study Director
Facility Information:
Facility Name
Oldham Healthy Minds IAPT
City
Oldham
State/Province
Lancashire
ZIP/Postal Code
OL11RU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Bee
Phone
0161 7162777
Email
charlotte.bee2@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Guided Self-help for Anxiety - a Patient Preference Trial

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