Psychotic DisordersPhase 1NCT02427542
Feasibility Trial of CBT for Depersonalisation in Psychosis
A Phase 1 study testing CBT for Depersonalization/Derealization and Treatment as usual in people with Psychotic Disorders and Depersonalization, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychotic Disorders, Depersonalization
- What is being tested?
- CBT for Depersonalization/Derealization and Treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current experience of psychotic symptoms,
- meeting threshold for DP/DR disorder (scores greater than 70 on Cambridge Depersonalization Scale (CDS)).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Cognitive Behavioural Therapy (CBT) Intervention for Depersonalisation/Derealisation in Psychosis: a Feasibility Study
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.
Read the 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
- Being tested
- CBT for Depersonalization/Derealization, Treatment as usual
- Keywords
- Randomized Controlled Trial
- Medical subject headings
- Psychotic Disorders, Depersonalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Depersonalization/DerealizationOther
In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.
Treatment as usualOther
Treatment as usual - in most cases case management/care coordination and may include medication
| Study group | Role | What they receive |
|---|---|---|
| CBT for DP | Active comparator | Six sessions of CBT covering psycho-education, formulation, enhancing coping strategies (including grounding) and cognitive restructuring techniques. Receives: Other: CBT for Depersonalization/Derealization |
| Treatment as usual | Placebo comparator | 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs)
Feasibility estimates of delivering the intervention including recruitment rates, acceptance rates, drop outs.
Measured: 10 weeks
Depersonalisation score (Score on the Cambridge Depersonalisation Scale)
Score on the Cambridge Depersonalisation Scale
Measured: 10 weeks
Acceptability of intervention (Satisfaction and attrition rates)
Satisfaction and attrition rates
Measured: 10 weeks
Secondary outcomes (3)
Depression (Score on Beck Depression Inventory)
Score on Beck Depression Inventory
Measured: 10 weeks
Anxiety (Score on Beck Anxiety Inventory)
Score on Beck Anxiety Inventory
Measured: 10 weeks
Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)
Score on the Psychotic Symptom Rating Scale (PSYRATS)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Farrelly, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427542
- Sponsor's protocol ID
- Protocol 141216v3
- Other IDs
- 15/LO/0081, 166784, R&D2015/017
- Status last verified
- Feb 2016
- First submitted
- 8 Apr 2015
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37716893Farrelly 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.
PubMed 27965864
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Cognitive Behavioural Therapy (CBT) Intervention for Depersonalisation/Derealisation in Psychosis: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02427542
- Acronym / sponsor ID
- Protocol 141216v3
- Conditions
- Psychotic Disorders, Depersonalization
- Keywords
- Randomized Controlled Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for DP | Active comparator | Other: CBT for Depersonalization/DerealizationSix sessions of CBT covering psycho-education, formulation, enhancing coping strategies (including grounding) and cognitive restructuring techniques. |
| Treatment as usual | Placebo comparator | Other: Treatment as usualParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current experience of psychotic symptoms,
- meeting threshold for DP/DR disorder (scores greater than 70 on Cambridge Depersonalization Scale (CDS)).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for Depersonalization/DerealizationIn addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies. | Other | CBT for DP |
| Treatment as usualTreatment as usual - in most cases case management/care coordination and may include medication | Other | Treatment as usual |
Primary outcome
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
3 secondary outcomes
Depression (Score on Beck Depression Inventory)
Time frame: 10 weeks
Anxiety (Score on Beck Anxiety Inventory)
Time frame: 10 weeks
Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Derived from this study: PubMed 37716893Farrelly 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.
- Derived from this study: PubMed 27965864Farrelly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Farrelly, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT for Depersonalization/Derealization and Treatment as usual in people with Psychotic Disorders and Depersonalization, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427542, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.