A 350-patient trial across ten UK sites is testing whether adding a self-compassion stabilisation phase before trauma-focused therapy improves outcomes for people with complex PTSD. This matters because complex PTSD—common after prolonged abuse or civil conflict—involves emotional dysregulation and interpersonal problems that standard trauma-focused treatments may not fully address. The World Health Organisation now recognises it as a distinct condition, yet no robust trial has tested whether the phased approach many clinicians already use actually works better than standard therapy. If phased therapy proves superior, clinical guidelines could shift to recommend a stabilisation-first model, giving patients a better chance at recovery. If it does not, services can stop wasting time and resources on an unproven extra phase. The trial also tracks dropouts, compliance, and patient experience, so even a negative result will tell clinicians what not to do. Therapy materials will be made freely available to NHS services.
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Complex posttraumatic stress disorder (CPTSD) is a highly distressing and disabling mental disorder. It is common among people who have experienced very long or repeated severe traumas such as childhood sexual abuse or civil conflict but can also occur after other traumas. The World Health Organisation has recently acknowledged CPTSD as a distinct clinical condition in ICD-11. Trauma-focused psychological treatments are recommended as first-line treatments for PTSD in NICE and international guidelines. However, a recent meta-analysis concluded that there is limited evidence that trauma-focused treatments are effective for the emotional dysregulation and interpersonal problems in CPTSD. While many clinicians and researchers advocate a phased approach to treating CPTSD where the trauma-focused work is preceded by a period of “stabilisation”, there is limited empirical evidence that phased interventions are more effective or acceptable than standard trauma-focused interventions. The aim of this study is to investigate whether a phased version of trauma-focused cognitive therapy for PTSD (TF-CT) that includes a self-compassion focused stabilisation phase, is superior in the treatment of CPTSD to nonphased TF-CT, one of the NICE-recommended treatments. Compassionate resilience offers a promising contribution as part of a phased approach, as it targets the three areas of poor self-regulation defined in ICD-11 CPTSD. A multicentre, pragmatic, individually randomised, parallel group randomised controlled trial will compare the effectiveness of phased TF-CT versus nonphased TF-CT for adult patients with CPTSD. 350 participants with CPTSD following a wide range of traumas and a wide range of symptom severity will be recruited from 5 sites in Northern Ireland and 5 sites in England over 18 months. They will be randomly allocated to 24 sessions of phased TF-CT or nonphased TF-CT. The main outcome assessment will take place at 26 weeks post randomisation and the main outcome measure is the International Trauma Questionnaire, which was designed to measure CPTSD symptoms as defined by ICD-11. Further outcome measures include independent assessments with the International Trauma Interview, and self-reports of depression, anxiety, disability, well-being, quality of life and health economic measures. Further assessments will take place at 9 weeks (post stabilisation in phased TF-CT), 17 weeks, 39 weeks, and 52 weeks post randomisation. Statistical analyses will be intent-to-treat. Imbedded in the study will be a treatment process evaluation investigating recruitment rates, drop-outs and compliance, treatment processes, and patient, therapist and service factors that may influence outcome, and a qualitative study of patient, family and therapist experience. We will also explore whether there are subgroups of patients with CPTSD for whom the potential advantages or disadvantages of a phased approach are greater than for others. We will incorporate an internal pilot over the first 6 months of recruitment with pre-specified “go/no-go” criteria. People who have lived experience with CPTSD and their family members will be involved in all phases of the research. The results will be made available through open access publications in international journals, conference presentations and presentation to stakeholders. Therapy materials will be made available to clinical services.
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