Feasibility Trial of CBT for Depersonalisation in Psychosis

Psychotic Disorders Clinical Trial

Official title:

A Brief Cognitive Behavioural Therapy (CBT) Intervention for Depersonalisation/Derealisation in Psychosis: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427542
• Other study ID #: Protocol 141216v3
• Secondary ID: 15/LO/0081166784
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2015
• Last updated: August 4, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depersonalization
• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• CBT for Depersonalization/Derealization
In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.
• Treatment as usual
Treatment as usual - in most cases case management/care coordination and may include medication

Locations

Country	Name	City	State
United Kingdom	PICUP clinic	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs)	Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.	10 weeks	No
Primary	Depersonalisation score (Score on the Cambridge Depersonalisation Scale)	Score on the Cambridge Depersonalisation Scale	10 weeks	No
Primary	Acceptability of intervention (Satisfaction and attrition rates)	Satisfaction and attrition rates	10 weeks	No
Secondary	Depression (Score on Beck Depression Inventory)	Score on Beck Depression Inventory	10 weeks	No
Secondary	Anxiety (Score on Beck Anxiety Inventory)	Score on Beck Anxiety Inventory	10 weeks	No
Secondary	Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)	Score on the Psychotic Symptom Rating Scale (PSYRATS)	10 weeks	No