This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 5 of 5 for:    "Depersonalization"

Feasibility Trial of CBT for Depersonalisation in Psychosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
King's College London
ClinicalTrials.gov Identifier:
NCT02427542
First received: April 8, 2015
Last updated: August 4, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Psychotic Disorders Depersonalization Other: CBT for Depersonalization/Derealization Other: Treatment as usual Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Brief Cognitive Behavioural Therapy (CBT) Intervention for Depersonalisation/Derealisation in Psychosis: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • 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.

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

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


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

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

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


Enrollment: 20
Study Start Date: March 2015
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02427542

Locations
United Kingdom
PICUP clinic
London, United Kingdom, SE5 8AZ
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Simone Farrelly, PhD King's College London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02427542     History of Changes
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 )
Study First Received: April 8, 2015
Last Updated: August 4, 2016

Keywords provided by King's College London:
Randomized Controlled Trial

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Depersonalization
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 13, 2017