Does a phased approach enhance outcomes for trauma-focused cognitive therapy for complex posttraumatic stress disorder?

Plain English Summary

Background and study aims
Cognitive Therapy for Posttraumatic Stress Disorder (CT-PTSD) is a NICE-recommended psychological therapy that has been shown to be effective and acceptable to patients in many research studies and clinical audits. Complex PTSD is a new diagnosis introduced into the diagnostic manual of the World Health Organisation (ICD-11) to characterise people who have unwanted memories of traumas, avoidance of reminders, high arousal and problems with emotion regulation, a negative view of themselves and problems maintaining relationships. This study aims to investigate how effective CT-PTSD is in clients treated across a wide range of services across Northern Ireland and England. The study will compare the delivery of CT-PTSD with and without a phased element. In one group, the treatment involves the immediate provision of CT-PTSD, which is adapted individually to each patient, and in the other group CT-PTSD is provided after eight sessions of compassionate resilience training (phased CT-PTSD). The study will consider whether both approaches work equally well or whether there are advantages in providing a phased approach or a non-phased approach for some groups of clients.

Who can participate?
Patients aged 18 years and above with complex PTSD

What does the study involve?
Participants who are eligible and wish to take part in the study will (after consent) be randomly allocated to one of two groups (phased or non-phased). Treatment in the trial involves 24 treatment sessions and regular assessments that measure progress during therapy and at follow-up time points. Questionnaires will be completed at the eligibility assessment, after 9 and 17 weeks of treatment, at the end of therapy (26 weeks) and 3 months (39 weeks) and 6 months after the end of therapy (52 weeks). These sets of questionnaires will take about 30 to 60 minutes to complete. Some of the questionnaires will also be given regularly during treatment to help the therapist with planning treatment sessions. At 2 and 10 weeks, participants will be asked some brief questions about their thoughts on the treatment. In addition, independent assessors will interview participants at the eligibility stage, end of treatment (26 weeks) and 6 months later (52 weeks). In total, your involvement with the study will be for 1 year.

What are the possible benefits and risks of participating?
Participants will be offered an evidence-based treatment for PTSD with or without a phased element under the supervision of experienced supervisors and trainers in CT-PTSD and Compassionate Resilience Training. Participants will be able to avail of one of these therapies under the controlled scrutiny and high standards required for a randomised controlled trial. Participation in this study also has the potential to make a valuable contribution to existing research on treatments for Complex PTSD.
With regard to risk, participant wellbeing is paramount and protocols are in place to ensure participants feel safe and support. Should a participant find any aspects of the study distressing, there will be a discussion around how the therapy will be adapted around the individual’s needs.

Where is the study run from?
The PHASE-CPTSD study is a collaboration between Queens University Belfast, the University of Oxford and ten HSC and NHS Foundation Trusts across Northern Ireland and England (UK)

When is the study starting and how long is it expected to run?
June 2020 to September 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
1. Dr Michael Duffy, michael.duffy@qub.ac.uk
2. Prof. Anke Ehlers, anke.ehlers@psy.ox.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• United Kingdom

Study participating centres

Sponsor information

Queen's University Belfast
University/education

Research and Governance Office
Queen's University Belfast
63 University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom

Phone	+44 (0)2890245133
Email	researchgovernance@qub.ac.uk
Website	http://www.qub.ac.uk
"ROR"	https://ror.org/00hswnk62

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN13869856_Protocol_V3.0_25Nov2024.pdf

Editorial Notes

09/01/2025: The following changes were made:
1. Protocol version 3.0 (not peer reviewed) added.
2. The recruitment end date was changed from 31/08/2024 to 30/06/2024.
3. The total final enrolment was added.
20/04/2023: The trial participating centre Ni Ambulance Service Health and Social Care Trust was changed to Belfast Health and Social Care Trust.
04/04/2023: The trial participating centre Step 4 Psychological Therapies was removed and South Bucks Psychological Therapies and South Camden iCope were added.
06/03/2023: Trial's existence confirmed by the South Central - Berkshire B Research Ethics Committee.