Feasibility Trial of CBT for Depersonalisation in Psychosis

Phase 1

Completed

• Conditions: Psychotic Disorders; Depersonalization
• Interventions: Other: CBT for Depersonalization/Derealization; Other: Treatment as usual

• Registration Number: NCT02427542
• Lead Sponsor: King's College London

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Status Verified: 2016-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT for DP	CBT for Depersonalization/Derealization	Six sessions of CBT covering psycho-education, formulation, enhancing coping strategies (including grounding) and cognitive restructuring techniques.
Treatment as usual	Treatment as usual	Participants will continue to receive their normal treatment - in most cases, this will be care coordination/case management delivered through a community mental health team and may include medication.

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs)	10 weeks	Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.
Depersonalisation score (Score on the Cambridge Depersonalisation Scale)	10 weeks	Score on the Cambridge Depersonalisation Scale
Acceptability of intervention (Satisfaction and attrition rates)	10 weeks	Satisfaction and attrition rates

Secondary Outcome Measures

Name	Time	Method
Depression (Score on Beck Depression Inventory)	10 weeks	Score on Beck Depression Inventory
Anxiety (Score on Beck Anxiety Inventory)	10 weeks	Score on Beck Anxiety Inventory
Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)	10 weeks	Score on the Psychotic Symptom Rating Scale (PSYRATS)

Trial Locations

Locations (1)

PICUP clinic; 🇬🇧 London, United Kingdom