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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03730532
Enrollment
134
Registered
2018-11-05
Start date
2019-01-29
Completion date
2020-09-30
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Guided self help, Cognitive Analytic Therapy, Cognitive Behavioral Therapy

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.

Interventions

OTHERCognitive Behavioural Therapy Guided Self Help

6-week manualised Cognitive Behavioural Therapy Guided Self Help

OTHERCognitive Analytic Therapy Guided Self Help

6-week manualised Cognitive Analytic Therapy Guided Self Help

Sponsors

University of Sheffield
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patient Preference Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Beck Anxiety InventoryMeasured at screening, at 6 weeks, 12 weeks and 24 weeksmeasuring change in anxiety at four time points

Secondary

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

Countries

United Kingdom

Contacts

Primary ContactSteve Kellett
s.kellett@sheffield.ac.uk+44114 222 6537
Backup ContactEmma Beattie-Edwards
ebeattieedwards1@sheffield.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026