Title: INterventions for Complex Traumatic Events: INCiTE
Funder: Department of Health and Social Care

Abstract: Design: Systematic review with meta-analysis of outcomes related to mental health symptom reduction and functioning and narrative synthesis of qualitative reports about patient and provider acceptability of interventions. Setting: Primary and specialist health care in high, middle and low income countries. Strategy for Reviewing Literature: Search of MEDLINE, PsycINFO, CDSR/DARE, PILOTS - Published International Literature on Traumatic Stress, and Web of Science for published randomised and non-randomised controlled trials of psychological and/or pharmacological therapies in people with complex trauma histories. Descriptive overview with meta-analysis of effectiveness; network meta-analysis for mixed treatment comparisons; qualitative narrative synthesis of patient/professional experience and ratings of acceptability of interventions; and stakeholder consultation exercise to set research priorities. Critical appraisal of trial data using Cochrane risk of bias tool for randomised and non-randomised trials; quality and certainty of qualitative evidence assessed using CerQual and CASP checklist. Target Population: Adults aged 18 years and over with stressor or trauma related disorders and/or psychiatric and psychological comorbidities following exposure to complex traumatic events defined as sustained or repeated instances of trauma of an interpersonal nature that are ‘extremely threatening or horrific and from which escape is difficult or impossible due to physical, psychological, maturational, family/environmental, or social constraints.’ Health Technologies Being Assessed: First and second line psychological therapy (delivered individually or in groups) and/or pharmacological therapy (SSRIs, SNRIs, tricyclic antidepressants, anxiolytic medication, mood stabilizers, atypical antipsychotics) aimed at improving mental health problems and/or symptoms of trauma-and stressor related disorders in people exposed to complex traumatic events. Measurement of Outcomes: Primary outcome of reduction in observer or self-rated symptoms of PTSD and/or reduction in symptoms of interpersonal relationship and emotional regulation difficulties; secondary outcomes in observer or self-rated symptoms of PTSD; reduction in symptoms of common mental health problems (depression, anxiety, panic disorder); symptoms of disassociation; rate of adverse events and harms (including suicidal ideation, attempts, and completion); reduction in symptoms of functional somatic syndromes; reduction in substance misuse; self-rated quality of life. Assessments of intervention uptake, adherence and withdrawal along with qualitative assessments of patient and provider acceptability. Project timetable: Set-up (m1-3), literature searching and cross checking with existing searches held by CCMD (m4-5), eligibility and data extraction (m6-9), narrative, statistical, and qualitative syntheses (m10-16), research prioritisation exercise (m16), final write-up and dissemination (m17-18). Expertise in team: Methods expertise in literature searching, systematic reviewing and overviews, meta-analysis, network meta-analysis, qualitative synthesis; PPI training, dissemination and knowledge mobilisation. Subject expertise in psychological and/or pharmacological treatment of psychological trauma and its related difficulties, with specific remit around complex trauma, dissociation, dissociation identity disorder, and comorbid personality disorders.

Lay abstract: People who have experienced repeated traumatic events such as survivors of childhood sexual abuse, refugees, and women trafficked into prostitution are more likely to develop mental health problems. These experiences are considered to be complex traumatic events and many affected people go on to develop trauma related disorders, such as post-traumatic stress disorder (PTSD), depression, and anxiety, and a number may also have personality disorders. Many people with a history of complex traumatic events struggle to cope with their experiences, and are also more likely to misuse alcohol and drugs. These health problems place a huge demand on services in the NHS and profoundly impact peoples’ quality of life – many suffer from poor mental and physical health, experience stigma and discrimination, and are more likely to be unemployed and in poverty. Psychological therapies (‘talking therapies’) and some antidepressant medications are effective in reducing PTSD symptoms. However, it is uncertain if treatments that are effective for PTSD resulting from a single traumatic event (e.g. a road traffic accident) are also effective for people with a history of complex traumatic events, who might have lots of psychological problems and PTSD. People with a history of complex traumatic events may respond, but they might require different approaches to treatment that first focus on making them feel safe and psychologically strong enough to deal with traumatic memories. The funder has asked for a review of all the available evidence to help decide which treatments might best help people with a history of traumatic events. We propose to systematically review previous research that has tested whether talking therapies and/or drug therapies can improve mental health problems in people with a history of complex traumatic events. A systematic review summarises all previous studies on a subject and helps to make recommendations about therapies and identify priorities for future research. We will also describe what is known about the acceptability of different treatments to those people who deliver and receive them. We will work in partnership with stakeholders, including service users with experience of complex traumatic events and health professionals expert in treating these conditions. We will look for evidence in a variety of ways including library databases, internet search engines, and linking up with an existing team of experts from the Cochrane Common Mental Disorders group who are involved in systematic reviews of treatments for PTSD. Our project will be conducted by a team of experts with excellent reputations and expertise in this area, including those who diagnose and manage mental health problems in people affected by complex traumatic events. We are funded for 18 months to cover the time of the team. Members of the research team will be involved in running the project, analysing and summarising the data, and reporting and presenting our findings. In addition we need to employ experienced workers to help us identify important documents, extract the useful information and analyse the data that we collect. Funding will also support service user involvement throughout the programme and support presentations of results to a wide range of public and professional audiences.

Research activity codes: 6.1 PHARMACEUTICALS;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH