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Feasibility Trial of CBT for Depersonalisation in Psychosis

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ClinicalTrials.gov Identifier: NCT02427542
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Depersonalization Other: CBT for Depersonalization/Derealization Other: Treatment as usual Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Brief Cognitive Behavioural Therapy (CBT) Intervention for Depersonalisation/Derealisation in Psychosis: a Feasibility Study
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBT for DP
Six sessions of CBT covering psycho-education, formulation, enhancing coping strategies (including grounding) and cognitive restructuring techniques.
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.

Placebo Comparator: 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.
Other: Treatment as usual
Treatment as usual - in most cases case management/care coordination and may include medication




Primary Outcome Measures :
  1. Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs) [ Time Frame: 10 weeks ]
    Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.

  2. Depersonalisation score (Score on the Cambridge Depersonalisation Scale) [ Time Frame: 10 weeks ]
    Score on the Cambridge Depersonalisation Scale

  3. Acceptability of intervention (Satisfaction and attrition rates) [ Time Frame: 10 weeks ]
    Satisfaction and attrition rates


Secondary Outcome Measures :
  1. Depression (Score on Beck Depression Inventory) [ Time Frame: 10 weeks ]
    Score on Beck Depression Inventory

  2. Anxiety (Score on Beck Anxiety Inventory) [ Time Frame: 10 weeks ]
    Score on Beck Anxiety Inventory

  3. Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS) [ Time Frame: 10 weeks ]
    Score on the Psychotic Symptom Rating Scale (PSYRATS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427542


Locations
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United Kingdom
PICUP clinic
London, United Kingdom, SE5 8AZ
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Simone Farrelly, PhD King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02427542    
Other Study ID Numbers: Protocol 141216v3
15/LO/0081 ( Other Identifier: Research Ethics Committee )
166784 ( Other Identifier: IRAS )
R&D2015/017 ( Other Identifier: R&D office )
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: February 2016
Keywords provided by King's College London:
Randomized Controlled Trial
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Depersonalization
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms