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Feasibility Trial of CBT for Depersonalisation in Psychosis

Primary Purpose

Psychotic Disorders, Depersonalization

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
CBT for Depersonalization/Derealization
Treatment as usual
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Randomized Controlled Trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PICUP clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBT for DP

Treatment as usual

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression (Score on Beck Depression Inventory)
Score on Beck Depression Inventory
Anxiety (Score on Beck Anxiety Inventory)
Score on Beck Anxiety Inventory
Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)
Score on the Psychotic Symptom Rating Scale (PSYRATS)

Full Information

First Posted
April 8, 2015
Last Updated
August 4, 2016
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT02427542
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Depersonalization
Keywords
Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for DP
Arm Type
Active Comparator
Arm Description
Six sessions of CBT covering psycho-education, formulation, enhancing coping strategies (including grounding) and cognitive restructuring techniques.
Arm Title
Treatment as usual
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CBT for Depersonalization/Derealization
Intervention Description
In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual - in most cases case management/care coordination and may include medication
Primary Outcome Measure Information:
Title
Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs)
Description
Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.
Time Frame
10 weeks
Title
Depersonalisation score (Score on the Cambridge Depersonalisation Scale)
Description
Score on the Cambridge Depersonalisation Scale
Time Frame
10 weeks
Title
Acceptability of intervention (Satisfaction and attrition rates)
Description
Satisfaction and attrition rates
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Depression (Score on Beck Depression Inventory)
Description
Score on Beck Depression Inventory
Time Frame
10 weeks
Title
Anxiety (Score on Beck Anxiety Inventory)
Description
Score on Beck Anxiety Inventory
Time Frame
10 weeks
Title
Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)
Description
Score on the Psychotic Symptom Rating Scale (PSYRATS)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Farrelly, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
PICUP clinic
City
London
ZIP/Postal Code
SE5 8AZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27965864
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.
Results Reference
derived

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Feasibility Trial of CBT for Depersonalisation in Psychosis

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