Feasibility Trial of CBT for Depersonalisation in Psychosis

NCT ID: NCT02427542

Last Updated: 2016-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

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.

Conditions

Psychotic Disorders; Depersonalization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT for DP

Six sessions of CBT covering psycho-education, formulation, enhancing coping strategies (including grounding) and cognitive restructuring techniques.

Group Type: ACTIVE_COMPARATOR

CBT for Depersonalization/Derealization

Intervention Type: OTHER

In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.

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.

Group Type: PLACEBO_COMPARATOR

Treatment as usual

Intervention Type: OTHER

Treatment as usual - in most cases case management/care coordination and may include medication

Interventions

CBT for Depersonalization/Derealization

In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.

Intervention Type: OTHER

Treatment as usual

Treatment as usual - in most cases case management/care coordination and may include medication

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simone Farrelly, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

PICUP clinic

London, London, United Kingdom

Countries

United Kingdom

References

Farrelly S, Peters E, Azis M, David AS, Hunter ECM. A brief CBT intervention for depersonalisation-derealisation disorder in psychosis: Results from a feasibility randomised controlled trial. J Behav Ther Exp Psychiatry. 2024 Mar;82:101911. doi: 10.1016/j.jbtep.2023.101911. Epub 2023 Sep 12.

Reference Type: DERIVED

PMID: 37716893 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27965864 (View on PubMed)

Other Identifiers

15/LO/0081

Identifier Type: OTHER

Identifier Source: secondary_id

166784

Identifier Type: OTHER

Identifier Source: secondary_id

R&D2015/017

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol 141216v3

Identifier Type: -

Identifier Source: org_study_id