NCT02427542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

April 8, 2015

Last Update Submit

August 4, 2016

Conditions

Psychotic DisordersDepersonalization

Keywords

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • Feasibility of intervention ( including recruitment rates, acceptance rates, drop outs)

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

    10 weeks

  • Depersonalisation score (Score on the Cambridge Depersonalisation Scale)

    Score on the Cambridge Depersonalisation Scale

    10 weeks

  • Acceptability of intervention (Satisfaction and attrition rates)

    Satisfaction and attrition rates

    10 weeks

Secondary Outcomes (3)

  • Depression (Score on Beck Depression Inventory)

    10 weeks

  • Anxiety (Score on Beck Anxiety Inventory)

    10 weeks

  • Psychosis (Score on the Psychotic Symptom Rating Scale (PSYRATS)

    10 weeks

Study Arms (2)

CBT for DP

ACTIVE COMPARATOR

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

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.

Other: Treatment as usual

Interventions

CBT for Depersonalization/DerealizationOTHER

In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.

CBT for DP
Treatment as usualOTHER

Treatment as usual - in most cases case management/care coordination and may include medication

Treatment as usual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current experience of psychotic symptoms,
  • meeting threshold for DP/DR disorder (scores greater than 70 on Cambridge Depersonalization Scale (CDS)).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PICUP clinic

London, London, SE5 8AZ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37716893DERIVED

  • 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.

    PMID: 27965864DERIVED

MeSH Terms

Conditions

Psychotic DisordersDepersonalization

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Simone Farrelly, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 28, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-02

Locations

GB(1)