Complex post-traumatic stress disorder Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A confirmed diagnosis of complex PTSD according to the International Trauma Questionnaire (ITQ) 2. Identified as suitable for trauma therapy and registered on a waiting list for therapy at one of the research sites 3. Age range 18-65 years old 4. Capacity to give informed consent and a basic command of the English language 5. Stable psychotropic medication (no medication or no change in medication in the last 3 months and no anticipated change)
Exclusion criteria
Exclusion criteria: 1. Organic mental disorder 2. Confirmed Diagnosis of Dissociative Identity Disorder 3. Psychotic mental states 4. No capacity to give informed consent (monitoring of capacity will occur throughout) 5. Risk of suicide or self-harming behaviour necessitating hospitalisation 6. Any medical condition that restricts movements severely (immobility)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PTSD symptoms measured using the PTSD Checklist for DSM-5 (PCL-5) at baseline, after therapy at 42 weeks, and at follow-up 3-months after the end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| The pre-test/post-test design will assess the following secondary outcome measures at baseline, at the end of the 40-week therapy, and 3-months follow-up: 1. Health-related subjective quality of life measured using the Subjective Quality of Life (Short Form-36 Health Survey) 2. Somatic symptom severity measured using the Patient Health Questionnaire-15 (PHQ-15) 3. Body image aberration measured using the Dresdner Body Image Scale (DKB-35) 4. Degree of somatic dissociation symptoms measured using the Somatoform Dissociation Questionnaire (SDQ-20) 5. Difficulties in Emotion Regulation measured using the Emotion Dysregulation Scale, short version (EDS-short) 6. Self-selected personal therapy goals measured using the Measure Yourself Medical Outcome Profile (MYMOP) scale 1. The intervention feasibility outcomes will be measured as: 1.1. The intervention sessions attended by each participant using data recorded during the study 1.2. Participants will be asked to rate the following questions after completing each session “How easy was it to participate in and complete this session?“ and “How useful was this session for you?“, on a scale of 0 (very difficult/not helpful) to 10 (very easy/very helpful). 2. The feasibility of outcome measures will be assessed as: The percentage of pre- and post-intervention questionnaires completed measured using data recorded during the study 3. Session impact will be assessed as: Participants are asked to rate their overall wellbeing and optimism (0–10) before and after each session, which are used to assess the immediate session impact. 4. Process evaluation will be assessed as: Personal safety, self-confidence, quality of relationship with others, stress reduction, and somatic symptom severity measured using a 5-item questionnaire rating attributes of the session on a continuum from 1 to 7 with their response after each session 5. Adherence to treatment fidelity measured according to a specific adherence scale (core components | — |
Countries
England, United Kingdom