Clinical trial NCT02427542: Feasibility Trial of CBT for Depersonalisation in Psychosis
Official title: A Brief Cognitive Behavioural Therapy (CBT) Intervention for Depersonalisation/Derealisation in Psychosis: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychotic Disorders
Depersonalization
Keywords: Randomized Controlled Trial
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a feasibility trial designed to test the feasibility and acceptability of a brief form (six sessions) of Cognitive Behavioural Therapy (CBT) for Depersonalisation/Derealisation (DP/DR) in those individuals who also have a diagnosis of a psychotic disorder. Participants will be randomised to receive either six sessions of CBT targeting DP/DR symptoms or to a treatment as usual control condition.

Detailed description: Depersonalisation/derealisation (DP/DR) are distressing symptoms of having a sense of detachment and unreality about oneself (DP) or the external world (DR). Cognitive Behavioural Therapy (CBT) has been found to be beneficial in treating patients with chronic DP/DR. CBT for DP/DR includes educating patients about these experiences so they have a better understanding and less fear; teaching ways of coping to help them manage the symptoms better; helping reduce the impact on their day to day functioning; and working together to find less distressing ways of interpreting these experiences. Recent research has highlighted that DP/DR symptoms are common in people diagnosed with psychotic disorders, and when present are linked with more severe psychotic symptoms. However, there has been no previous study to ascertain if CBT to target DP/DR in psychosis would be effective. This study therefore aims to establish the feasibility of a brief CBT intervention for DP/DR in people diagnosed with a psychotic disorder. It is hoped that the CBT will reduce the distress associated with DP/DR experiences, with a possibility of reducing psychotic phenomena in addition. The investigators will seek to recruit adults aged 18-70 with a current psychotic symptoms as well as meeting threshold for DP/DR disorder. Participants will be randomly assigned to receive six sessions of CBT or to a treatment as usual control. Outcomes will be assessed at baseline and follow-up interview at 10 weeks.

Eligibility criteria: Inclusion Criteria:

* current experience of psychotic symptoms,
* meeting threshold for DP/DR disorder (scores greater than 70 on Cambridge Depersonalization Scale (CDS)).

Exclusion Criteria:

* insufficient capacity to provide informed consent;
* insufficient proficiency in English (spoken and written) to engage in CBT;
* a primary diagnosis of intellectual disability, head injury, substance misuse or organic cause for psychosis;
* those currently engaging in CBT or other psychotherapy.

Primary outcomes:
measure: Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs)
timeFrame: 10 weeks
measure: Depersonalisation score (Score on the Cambridge Depersonalisation Scale)
timeFrame: 10 weeks
measure: Acceptability of intervention (Satisfaction and attrition rates)
timeFrame: 10 weeks
Secondary outcomes:
measure: Depression (Score on Beck Depression Inventory)
timeFrame: 10 weeks
measure: Anxiety (Score on Beck Anxiety Inventory)
timeFrame: 10 weeks
measure: Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: PICUP clinic
Study officials:
affiliation: King's College London
name: Simone Farrelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farrelly S, Peters E, Azis M, David A, Hunter EC. A brief CBT intervention for depersonalisation/derealisation in psychosis: study protocol for a feasibility randomised controlled trial. Pilot Feasibility Stud. 2016 Aug 11;2:47. doi: 10.1186/s40814-016-0086-7. eCollection 2016.