ISRCTN ISRCTN43471225
DOI https://doi.org/10.1186/ISRCTN43471225
Integrated Research Application System (IRAS) 363155
Sponsor Oxford Health NHS Foundation Trust
Funder NIHR Oxford Biomedical Research Centre
Submission date
12/02/2026
Registration date
13/02/2026
Last edited
13/02/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Panic disorder is often treated in NHS talking therapies services by psychological well-being practitioners (PWPs) at Step Two, also known as 'low intensity'. There is a need to improve recovery rates for panic disorder nationally in NHS talking therapies services. A previous pre-registered trial the authors conducted (now published) found a more specific psychological treatment for panic disorder (known as Focused CBT) was more effective than the current treatment as usual for panic disorder in NHS Talking Therapies services. Therefore, this study is being conducted to build on the previous research to examine if these same effects can be observed on a larger scale.

The research also aims to examine if focused CBT can result in further improvements on panic and agoraphobic specific measures including fearful panic thoughts and agoraphobic avoidance.

Who can participate?
Individuals who are 18+ years of age, of any sex and where panic disorder with or without agoraphobia is the main problem.

What does the study involve?
People with panic disorder at the NHS talking therapies service are asked if they would like to take part in the study. If so, they will be randomly placed (determined by chance) into either the 'focused CBT' treatment or the current treatment provided for panic disorder at the NHS talking therapies services. Participants will then receive the treatment they have been randomly allocated to. The symptoms and severity of the participant's panic, depression, anxiety and the participant's daily functioning are measured before they start treatment, during each treatment session and at the end of treatment. Panic fearful thoughts and agoraphobic avoidance are measured before treatment begins, mid-way through treatment and at the end of treatment.

What are the possible benefits and risks of participating?
Taking part could help improve the current psychological treatment for panic disorder with or without agoraphobia. It could also help with wider implementation of this focused CBT if deemed more effective. In addition, it would also mean participants will obtain psychological treatment for panic disorder with or without agoraphobia which may help with their difficulties with panic.

The research team do not anticipate any risk associated with taking part.

Where is the study run from?
Oxford Health NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
February 2026 - December 2027

Who is funding the study?
Biomedical Research Centre NIHR - Oxford Health NHS Foundation Trust (UK)

Who is the main contact?
1. Dr Saarim Aslam, saarim.aslam@psy.ox.ac.uk
2. Professor Paul Salkovskis, paul.salkovskis@hmc.ox.ac.uk

Contact information

Dr Saarim Aslam
Public, Scientific, Principal investigator

University of Oxford, Department of Experimental Psychology
Oxford Health NHS Foundation Trust
Isis Education Centre
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

ORCiD logoORCID ID 0000-0001-7488-904X
Phone +44 (0)7919819678
Email saarim.aslam@psy.ox.ac.uk
Prof Paul Salkovskis
Public, Scientific

The Oxford Institute of Clinical Psychology Training and Research
University of Oxford, Department of Experimental Psychology
Oxford Health NHS Foundation Trust
Isis Education Centre
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

ORCiD logoORCID ID 0000-0002-2951-2283
Phone +44 (0)1865 226 369
Email paul.salkovskis@hmc.ox.ac.uk

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposeTreatment
Scientific titleImproving talking therapies treatment of panic disorder: a randomised parallel trial
Study objectives 1. Can we replicate previous study findings with a new, larger sample? That is, a difference in the clinical outcome of panic severity between individuals with panic disorder who receive focused CBT compared to those who receive Step Two Treatment As Usual (TAU).
2. Is there a difference in the clinical outcomes of depression, anxiety and one’s daily functioning between individuals with panic disorder who receive focused CBT compared to those who receive Step Two Treatment As Usual (TAU) on a larger scale?
3. Does agoraphobic avoidance and panic cognitions improve in line with panic outcomes and do they predict outcomes in panic severity?
Ethics approval(s)

Approved 16/12/2025, South West - Cornwall & Plymouth Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048071; cornwallandplymouth.rec@hra.nhs.uk), ref: 25/SW/0156

Health condition(s) or problem(s) studiedPanic disorder with or without agoraphobia
Intervention1. Focused CBT: This will involve six-eight sessions, delivered by Qualified Psychological Wellbeing Practitioners (PWPs). Participants randomly allocated to this treatment will receive workbook modules to complete which will introduce each session's topic. They will be required to complete the workbook modules before each session as these workbooks will be used by the PWPs with the participants during the treatment sessions. The workbook modules and treatment sessions will use cognitive behavioural therapy (CBT) techniques tailored to panic disorder to help participants with their panic symptoms.

2. Treatment as usual has two different treatments which are currently provided by the NHS Talking Therapies Services taking part. These are (i) Guided Self Help (GSH) and (ii) computerised CBT (cCBT). GSH involves a consultation with a PWP followed by six-eight treatment sessions whereby the participant will be guided through different skills and techniques to help with the panic symptoms and difficulties. They are also given workbooks to complete prior to the sessions. cCBT is delivered on an online platform which involves seven modules teaching participants skills to help with their panic symptoms and involves online reviews by a PWP.

Random allocation: Participants will be randomly allocated to either focused CBT or treatment as usual. Randomisation is being stratified by site and using blocked randomisation. The tool used will be an online randomisation tool such as ‘Sealed Envelope’. If participants are randomly allocated to treatment as usual, they will follow normal NHS Talking Therapies service procedures for allocation to either cCBT or GSH which involves a discussion of these options with the participant and an agreement between the participant and clinician of which is the most suitable option for them. This is the normal procedure for TAU in these services.

Administration: Focused CBT is administered face-to-face or online via MS Teams. Both cCBT and GSH are administered either face to face, online via MS Teams or by telephone. This is based on participant preference and clinical need.

Duration:
Focused CBT intervention is a total of 6-8 weeks which is dependent upon the individual's panic presentation. Treatment as usual which is both Guided Self Help and Computerised CBT is also for 6-8 weeks. There is no follow up for this study.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Panic symptom severity measured using Panic Disorder Severity Scale (PDSS) at pre treatment, at each treatment session and end of treatment.
Key secondary outcome measure(s)
  1. Depression measured using PHQ-9 at pre treatment, at each treatment session and end of treatment
  2. Anxiety measured using GAD-7 at pre treatment, at each treatment session and end of treatment
  3. Work and social adjustment scale measured using Work and Social Adjustment Scale (WSAS) at pre treatment, at each treatment session and end of treatment
  4. Agoraphobia measured using Modified Agoraphobic Cognitions Questionnaire at pre, mid and end of treatment
  5. Mobility measured using Mobility Inventory at pre, mid and end of treatment
Completion date31/12/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit110 Years
SexAll
Target sample size at registration94
Key inclusion criteria1. Age 18+
2. English speaking and able to complete questionnaires and workbooks in English
3. Any gender
4. The presence of recurrent panic attacks whereby some are unexpected
5. Panic disorder with or without agoraphobia is the main problem as identified in the problem descriptor
Key exclusion criteria1. Panic is not the primary difficulty
2. Individual does not have capacity to consent
3.Those with long term physical health conditions
4. Those who are involved in another research project
5. Risk/safeguarding cannot be managed
6. Substance/alcohol use that would impact on therapy and individual unwilling to work to reduce this use
7. Inability to access materials, for example, technology barriers
Date of first enrolment20/02/2026
Date of final enrolment31/08/2027

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Oxford Health NHS Foundation Trust
Littlemore Mental Health Centre
Sandford Road
Littlemore
Oxford
OX4 4XN
England

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

12/02/2026: Trial's existence confirmed by NHS HRA.