Does a phased approach enhance outcomes for CT-PTSD for Complex PTSD?
Research type
Research Study
Full title
Does a Phased Approach Enhance Outcomes for Trauma-Focused Cognitive Therapy (CT-PTSD) for Complex Posttraumatic Stress Disorder (CPTSD)?
IRAS ID
309119
Contact name
Michael Duffy
Contact email
Sponsor organisation
Queens University Belfast
ISRCTN Number
ISRCTN13869856
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Complex PTSD is a distressing and disabling condition common among people who have experienced long or repeated severe traumas (e.g. childhood sexual abuse; civil conflict), but can also occur after other traumas. It has recently been recognised as a separate diagnosis from PTSD in ICD-11 because of additional symptoms, such as emotion dysregulation and interpersonal relationship difficulties. Current treatment provision for CPTSD is variable across the UK health service and not enough evidence exists to answer questions for planning what treatments to offer. It is unclear: (i) whether the trauma-focused first-line psychological treatments recommended by NICE improve all CPTSD symptoms; (ii) whether the trauma-focused treatment should start right away or after a preparatory phase of “stabilisation”; (iii) which patients may benefit most from a phased treatment approach, and if so, what are the possible explanatory factors.
The study will compare the delivery of TF-CT with and without a phased element. In one group, the treatment involves the immediate provision of the CT-PTSD protocol, which is adapted individually to each patient, and in the other group CT-PTSD is provided after 8 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 patients. A phased treatment plan, which first focuses on building compassion resilience and emotion regulation skills before commencing CT-PTSD sessions, has been successfully piloted by one of the co-investigators (D Lee). People with lived experience of CPTSD and their family members will be involved in all stages of the research. A minimum of 350 eligible patients will be recruited from 5 (NI) and 5 UK sites (England) over 18 months. They will be randomly allocated to to either, up to 24 sessions of phased CT-PTSD, or up to 24 sessions of CT-PTSD (non-phased). After treatment, patients will be followed up to 52 weeks from randomisation i.e. six months follow-up from end of standard treatment for majority of participants.
Recruiting services will include IAPT Services in England and Specialist Trauma Services in England and Northern Ireland. This will ensure that a diverse range of patients with a variety of traumas and CPTSD severity are included in the RCT, making the results more generalizable.
We will also test whether phased CT-PTSD works better than non-phased CT-PTSD to improve other symptoms (e.g. depression, well-being and quality of life) and is cost-effective. We will examine possible mediators of participant outcomes (e.g. changes in PTSD-specific cognitive processes; aspects of the therapeutic working alliance; levels of self-criticism). We will also interview some patients, patients’ family members and therapists about their experience with the treatment they received or delivered.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0466
Date of REC Opinion
20 Dec 2022
REC opinion
Favourable Opinion