Guided Self-help for Anxiety - a Patient Preference Trial

NCT ID: NCT03730532

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2020-09-30

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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient Preference Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Randomised CBT

Cognitive Behavioural Therapy Guided Self Help

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy Guided Self Help

Intervention Type OTHER

6-week manualised Cognitive Behavioural Therapy Guided Self Help

Randomised CAT

Cognitive Analytic Therapy Guided Self Help

Group Type EXPERIMENTAL

Cognitive Analytic Therapy Guided Self Help

Intervention Type OTHER

6-week manualised Cognitive Analytic Therapy Guided Self Help

Preference CAT

Cognitive Analytic Therapy Guided Self Help

Group Type EXPERIMENTAL

Cognitive Analytic Therapy Guided Self Help

Intervention Type OTHER

6-week manualised Cognitive Analytic Therapy Guided Self Help

Preference CBT

Cognitive Behavioural Therapy Guided Self Help

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy Guided Self Help

Intervention Type OTHER

6-week manualised Cognitive Behavioural Therapy Guided Self Help

Interventions

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Cognitive Behavioural Therapy Guided Self Help

6-week manualised Cognitive Behavioural Therapy Guided Self Help

Intervention Type OTHER

Cognitive Analytic Therapy Guided Self Help

6-week manualised Cognitive Analytic Therapy Guided Self Help

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

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Emma Beattie-Edwards

Trainee Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steve Kellett

Role: STUDY_DIRECTOR

University of Sheffield

Locations

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Oldham Healthy Minds IAPT

Oldham, Lancashire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Steve Kellett

Role: CONTACT

+44114 222 6537

Emma Beattie-Edwards

Role: CONTACT

Facility Contacts

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Charlotte Bee

Role: primary

0161 7162777

References

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Kellett S, Bee C, Smithies J, Aadahl V, Simmonds-Buckley M, Power N, Dugen-Williams C, Fallon N, Delgadillo J. Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial. Br J Psychiatry. 2023 Sep;223(3):438-445. doi: 10.1192/bjp.2023.78.

Reference Type DERIVED
PMID: 37395600 (View on PubMed)

Other Identifiers

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240751

Identifier Type: -

Identifier Source: org_study_id

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