Title: Does a Phased Approach Enhance Outcomes for Trauma-Focused Cognitive Therapy for Complex Posttraumatic Stress Disorder?
Funder: Department of Health and Social Care

Abstract: Complex posttraumatic stress disorder (CPTSD) is a highly distressing and disabling condition. 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, and has recently been recognised as a separate diagnosis from posttraumatic stress disorder (PTSD) because it has additional symptoms such as problems with regulating emotions and problems in interpersonal relationships. Current treatment provision for CPTSD is highly variable across the National Health Service and Health and Social Care Service. Furthermore, there is not enough evidence to answer important questions for planning what treatments to offer. First, it is unclear whether the trauma-focused psychological treatments recommended for PTSD by the National Institute for Health and Care Excellence (NICE) improve all of the CPTSD symptoms. Second, it is unclear whether the trauma-focused treatment should start right away or after a phase of “stabilisation” where patients learn a range of skills that prepare them for working on their traumas and help them manage some of their symptoms. Third, it is unclear which patients would benefit most from such a phased treatment approach and for whom it may work less well than nonphased treatment. The proposed study is designed to answer these questions._x000D_ _x000D_ The aim of the study is to investigate whether a phased treatment works better for people with CPTSD than a nonphased NICE recommended treatment. A randomised controlled trial will compare how effective a phased and a nonphased version of trauma-focused cognitive therapy are in treating CPTSD. Cognitive therapy for PTSD (CT) is one of the NICE-recommended first-line treatments for PTSD that has been shown to work with PTSD following a wide range of traumas. A phased treatment that first focuses on building compassionate resilience and emotion regulation before cognitive therapy has been successfully piloted by one of the applicants._x000D_ _x000D_ A total of at least 350 patients with CPTSD will be recruited from 5 sites in Northern Ireland and 5 sites in England over 18 months. They will be allocated by chance to either 24 sessions of the phased treatment or 24 sessions of nonphased CT using a computer programme. After the end of treatment, patients will be followed up for 12 months. Services will range from Improving Access to Psychological Therapies Services to Specialist Trauma Services. This will ensure that patients with a wide range of traumas, diversity and CPTSD severity are included in the trial and allow us to draw conclusions from the results about CPTSD in general._x000D_ _x000D_ We will test whether the phased treatment works better than the nonphased treatment in improving CPTSD symptoms, other symptoms such as depression, well-being and quality of life and is cost-effective. We will also explore whether the potential advantages and disadvantages between the phased and nonphased treatment are larger for some groups of patients. We will interview some of the patients, family members and therapists about their experience with the phased and the nonphased treatment. People who have lived experience with CPTSD and their family members will be involved in all phases of the research._x000D_ _x000D_ 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.

Lay abstract: 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH