Feasibility Trial of CBT for Depersonalisation in Psychosis

• Sponsor: King's College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02427542
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs) [10 weeks]

   Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.

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

   Score on the Cambridge Depersonalisation Scale

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

   Satisfaction and attrition rates

Secondary Outcome Measures

1. Depression (Score on Beck Depression Inventory) [10 weeks]

   Score on Beck Depression Inventory

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

   Score on Beck Anxiety Inventory

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

   Score on the Psychotic Symptom Rating Scale (PSYRATS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	PICUP clinic	London		United Kingdom	SE5 8AZ

Sponsors and Collaborators

• King's College London

Investigators

• Principal Investigator: Simone Farrelly, PhD, King's College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: King's College London
• ClinicalTrials.gov Identifier: NCT02427542
• Other Study ID Numbers: Protocol 141216v3; 15/LO/0081; 166784; R&D2015/017
• First Posted: Apr 28, 2015
• Last Update Posted: Aug 8, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by King's College London: Randomized Controlled Trial
• Additional relevant MeSH terms: Psychotic Disorders; Mental Disorders; Depersonalization

Study Results

No Results Posted as of Aug 8, 2016