Effectiveness of focused CBT for panic disorder
| ISRCTN | ISRCTN11268881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11268881 |
| IRAS number | 333071 |
| Secondary identifying numbers | IRAS 333071 |
- Submission date
- 15/01/2024
- Registration date
- 23/01/2024
- Last edited
- 28/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Panic disorder is often treated in NHS talking therapies services by psychological well-being practitioners (PWPs). There is a need to improve recovery rates for panic disorder in local NHS talking therapies. Therefore, the primary aim of this study is to improve the recovery rates for panic disorder in two local NHS talking therapy services by delivering training to PWPs in a treatment called 'Focused Cognitive Behavioural Therapy (CBT)' and to see if this treatment is more effective or not than the current psychological treatment for panic disorder. In addition, research has shown that panic disorder is often maintained by behaviours known as 'safety-seeking behaviours' and reducing or stopping these behaviours can help with treatment. These behaviours aim to help someone with panic disorder stop a catastrophic event from happening. For example, someone with panic disorder may sense that their heart rate has increased, believing this indicates a heart attack is occurring, therefore to stop this from happening they will engage in a safety-seeking behaviour such as asking for help. However, some research has suggested that these safety-seeking behaviours are not bad and can help someone with panic disorder during psychological treatment. Also, no research has examined the impact of 'approach supporting behaviours' which are behaviours that can help someone confront their fears. Therefore, another aim is to investigate, if there is a difference between focused CBT and the current treatment of panic disorder in NHS Talking therapies, that may explain this. Could the use of approach-supporting behaviours and reducing/stopping safety-seeking behaviours explain any differences between the treatments?
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 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. Safety-seeking behaviours and approach-supporting behaviours 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 in two local NHS Talking Therapies services. 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?
The University of Oxford.
When is the study starting and how long is it expected to run for?
November 2023 to December 2024
Who is funding the study?
Oxford Health NHS Foundation Trust. This research is part of the main contact's (Saarim Aslam) Doctorate in Clinical Psychology Thesis, at the University of Oxford.
Who is the main contact?
1. Saarim Aslam, saarim.aslam@stx.ox.ac.uk
2. Professor Paul Salkovskis, paul.salkovskis@hmc.ox.ac.uk
Contact information
Public, Scientific, Principal Investigator
University of Oxford
The Oxford Institute of Clinical Psychology Training and Research
Oxford Health NHS Foundation Trust
Isis Education Centre
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
 ORCID ID |
0000-0001-7488-904X |
|---|---|
| Phone | +44 (0)7919819678 |
| saarim.aslam@stx.ox.ac.uk |
Scientific
The Oxford Institute of Clinical Psychology Training and Research
University of Oxford
Isis Education Centre
Warneford Hospital
Oxford
Oxford
OX3 7JX
United Kingdom
| ORCID ID |
0000-0002-2951-2283 |
|---|---|
| Phone | +44 (0)1865 226 369 |
| paul.salkovskis@hmc.ox.ac.uk |
Public, Scientific
The Oxford Institute of Clinical Psychology Training and Research
University of Oxford
Isis Education Centre
Warneford Hospital
Oxford
Oxford
OX3 7JX
United Kingdom
| ORCID ID |
0000-0002-5297-7919 |
|---|---|
| Phone | +44 (0)1865 226 369 |
| angie.jenkin@hmc.ox.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluating the effectiveness of a focused CBT training for panic disorder with or without agoraphobia |
| Study hypothesis | 1. Individuals with panic disorder with or without agoraphobia who receive focused CBT treatment delivered by trained PWPs will show a greater reduction in panic symptom severity compared to those who receive the current step 2 psychological treatment for panic disorder with or without agoraphobia. 2. Individuals with panic disorder with or without agoraphobia who receive focused CBT treatment from trained PWPs will show a greater reduction in anxiety and depression and will show an improvement in daily functioning compared to those individuals who receive the current step 2 psychological treatment for panic disorder with or without agoraphobia. Exploratory aim: If differences in panic symptom severity occur between those receiving focused CBT and the current step 2 psychological treatment for panic disorder, what mechanisms could underlie this difference? |
| Ethics approval(s) |
Approved 22/12/2023, South West - Cornwall & Plymouth Research Ethics Committee (Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; cornwallandplymouth.rec@hra.nhs.uk), ref: 23/SW/0151 |
| Condition | Panic disorder with or without agoraphobia |
| Intervention | 1. Focused CBT: This will involve six 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 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 treatment sessions whereby the participant will be guided through different skills and techniques to help with the panic symptoms and difficulties. 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. 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. |
| Intervention type | Behavioural |
| Primary outcome measure | Panic symptom severity measured using the Panic Disorder Severity Scale (PDSS) at pre-treatment, each treatment session and the end of treatment |
| Secondary outcome measures | 1. Depression measured using the Patient Health Questionnaire (PHQ-9) at pre-treatment, each treatment session and the end of treatment 2. Anxiety measured using Generalised Anxiety Disorder Assessment (GAD-7) at pre-treatment, each treatment session and the end of treatment 3. Daily functioning measuring using the Work and Social Adjustment Scale (WSAS) at pre-treatment, each treatment session and the end of treatment 4. Safety-seeking and approach-supporting behaviours measured using the Panic Safety Seeking and Approach Supporting Behaviours Questionnaire (P-SSASBQ) at pre-, mid and the end of treatment (this is to help answer an exploratory aim). |
| Overall study start date | 06/11/2023 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 72 |
| Participant inclusion criteria | 1. Age 18+ (no upper age limit) 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 |
| Participant exclusion criteria | 1. Panic is not the primary difficulty 2. Individuals who cannot consent 3. Those with long-term conditions 4. Involvement in another research project 5. Risk/safeguarding cannot be managed 6. Substance/alcohol use that would impact therapy and individuals unwilling to work to reduce this use 7. Inability to access materials, for example, technology barriers |
| Recruitment start date | 29/01/2024 |
| Recruitment end date | 08/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Warneford Hospital
Oxford
Oxford
OX3 7JX
England
United Kingdom
| Phone | None provided |
|---|---|
| research@oxfordhealth.nhs.uk | |
| Website | https://www.oxfordhealth.nhs.uk/ |
"ROR" |
https://ror.org/04c8bjx39 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- OxfordHealthNHS, Oxford Health NHS (UK), Oxford Health NHS FT, OHFT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 03/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the detailed level of information gathered. |
Editorial Notes
28/10/2024: The total final enrolment number was corrected from 60 to 72.
22/10/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The study participating centres NHS Oxfordshire Talking Therapies, NHS Buckinghamshire Talking Therapies were removed and Oxford Health NHS Foundation Trust was added.
16/01/2024: Study's existence confirmed by the Health Research Authority (HRA) (UK).
