Depersonalisation-Derealisation Disorder (DDD) Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 16-75 years 2. Have current symptoms of DDD meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria
Exclusion criteria
Exclusion criteria: 1. People having previously had CBT specifically for DDD 2. Where there are co-morbid current diagnoses of: 2.1. Psychosis spectrum disorder 2.2. Substance dependence 2.3. Intellectual disability 2.4. Cognitive impairment due to head injury or organic disorder 2.5. Post-traumatic stress disorder (PTSD) 3. Participants lacking the capacity to consent to take part in the study 4. Insufficient proficiency in the English language to engage in CBT 5. Requiring special communication needs arrangements. 6. People who are not registered with a GP 7. Those with depersonalisation and/or derealisation symptoms which score below clinical severity (i.e., a total score of 0-2) in response to the diagnostic questions 8. Participants involved in other research studies involving mental or physical health research (including drug trials)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes relate to the feasibility and acceptability measures (see below). The researchers will use a traffic light system to establish the success of the trial based on each measure. 1. Recruitment/eligibility data: collected throughout the recruitment period (6-month window, includes Time 0 and Time 1) 2. Participant attrition rates: collected throughout participant journey (12 months), and reviewed at each timepoint (Time 0-3) 3. Therapist attrition rates and reasons for withdrawing throughout the study: collected throughout the recruitment and intervention period (Time 0-2) 4. Resources needed to complete CBT-f-DDD: 4.1. Length of time required for RAs to complete assessments and collect and analyse data (from research assistant time sheets - collected at each time point, Time 0-3, throughout the study), CBT attendance rates (from electronic patient records - Time 1-2), and the amount and nature of supervision required (from Co-PI supervision notes - Time 1-2) 4.2. A minimum of 12 sessions and a maximum of 24 weekly sessions are established for the 6- month window, allowing for 50% attendance rates (Time 1-2, 6 months) 5. Therapist adherence to CBT-f-DDD (fidelity) (Time 1-2): Records of session content, participants’ engagement with CBT-f-DDD, and homework tasks completed (all from therapist post-session checklists). A random sample of 10% of audio-recorded therapy sessions will be evaluated using standardised CBT protocols for adherence to the CBT model as well as an adapted CBT-f-DDD checklist 6. Participant acceptability (Time 2 and 3): 6.1. Acceptability of assessment procedures and measures (Time 2 and 3) 6.2. Acceptability of CBT-f-DDD including aspects of the treatment found helpful and unhelpful, perceived impact of the intervention, and satisfaction with the intervention and therapists (from thematic analysis of the qualitative interviews [Time 3]; and as measured by items on the end-of-treatment questionnaire “CBT-f-DDD brief outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health data and demographics: Health economic outcomes measured using the Client Service Receipt Inventory (CSRI) at Time 0, 2 and 3 2. Clinical data: 2.1. Depersonalisation-Derealisation Disorder measured using the Cambridge Depersonalization Scale (CDS) at Time 0-3 2.2. Dissociation measured using the Dissociative Experiences Scale (DES) at Time 0-3 2.3. Depression measured using Patient Health Questionnaire (PHQ)-9 at Time 0-3 2.4. Anxiety measured using Generalised Anxiety Disorder Assessment (GAD-7) at Time 0-3 2.5. Co-morbidity measured using Clinical Interview Schedule - Revised (CIS-R) at Time 0 and 3 2.6. Functioning measured using the Work and Social Adjustment scale (WASA) at Time 0-3 2.7. Global rating of change question (i.e., “do you feel better?”) at Time 2 2.8. Quality of life measured using EQ-5D-5L at Time 0, 2 and 3 2.9. Clinical characteristics including the age of onset of DDD, duration, co-morbid diagnoses, previous treatments for DDD, type and dosage of current medication; measured using semi-structured interview of DDD experiences (Time 0-3) and CSRI (Time 0, 2 and 3) | — |
Countries
England, United Kingdom