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A Study of an Cognitive Behaviour Therapy for Internalised Stigma Intervention for Inpatients With Psychosis

Primary Purpose

Cognitive Behaviour Therapy for Internalised Stigma, Psychoeducation

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behaviour Therapy
Psychoeducation
Sponsored by
Lisa Wood
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Behaviour Therapy for Internalised Stigma focused on measuring internalised stigma, self stigma, inpatients, CBT, Cognitive therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-65
  • Who meet criteria for a schizophrenia-spectrum diagnoses (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified; ICD-10)
  • Able to give in-formed consent and have capacity to consent
  • Receiving care from a clinical in-patient team
  • Able to complete the interview in English
  • Self-report being concerned about stigma

Exclusion Criteria:

  • Non-English speakers (due to translation costs)
  • An acquired brain injury or substance misuse judged to be the acute cause of the psychotic experiences
  • Lacking capacity for informed consent (the applicant will work with the participant to assess whether they understand the information sheet and study and therefore their ability to give informed consent)
  • Experiencing severe thought disorder

Sites / Locations

  • North east london foundation trustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioural therapy

Psychoeducation

Arm Description

Cognitive behaviour therapy

psychoeducation

Outcomes

Primary Outcome Measures

Internalised stigma of mental illness scale

Secondary Outcome Measures

Process of Recovery Questionnaire
Beck Depression Inventory
Beck Hopelessness Scale
Self-Esteem Rating scale
Attitudes towards mental health scale

Full Information

First Posted
July 29, 2016
Last Updated
August 3, 2016
Sponsor
Lisa Wood
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1. Study Identification

Unique Protocol Identification Number
NCT02853396
Brief Title
A Study of an Cognitive Behaviour Therapy for Internalised Stigma Intervention for Inpatients With Psychosis
Official Title
A Pilot of a Brief Cognitive Behaviour Therapy Formulation Focused Intervention for Internalised Stigma With Acute Inpatients That Experience Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa Wood

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stigma is a significant concern for those who experience psychosis. People with psychosis are the most stigmatised group of all mental health difficulties. There is a lack of research examining the effectiveness of psychological therapies for people who experience psychosis who are also experiencing negative impacts of stigma. To date, all studies examining stigma therapies have been conducted with outpatients and no support have been developed for inpatients. The aim of this study to conduct a pilot randomised controlled trial of a brief therapy (based on cognitive behavioural therapy)to help participants cope with stigma. It will be compared to a educational control intervention. Both therapies will last approximately two hours and be conducted in one or two sessions by the principal investigator (clinical psychologist). Participants will be given a number of questionnaires assessing a number of outcomes such as impacts of stigma, depression, recovery, and self-esteem. Participants will be assessed on these measure prior to the therapy, post therapy and at follow-up.
Detailed Description
A single-blind randomised controlled pilot trial will be conducted comparing a Cognitive Behaviour Therapy formulation driven internalised stigma intervention (experimental group) against a psychoeducational control intervention (control group). It will follow recommendations outlined by the Medical Research Council's framework for the development and evaluation of complex interventions. This will allow for the medication of the intervention if necessary in order to examine what type of intervention is best suited to the inpatient environment. Aim: To examine the efficacy of a formulation driven intervention for internalised stigma in psychosis with acute inpatients. The intervention will be compared to a brief psychoeducational internalised stigma intervention. Description of therapies: Experimental Condition The experimental condition will receive a two hour intervention session (across one or two sessions) which will be based on a Cognitive Behaviour therapy formulation. These sessions will be undertaken within a two week period. The sessions will collaboratively assess and create a narrative of the participants' experiences of stigma, and develop a personalised stigma formulation. A stigma-related goal will be identified and a brief intervention will be collaboratively developed to tackle this goal. The intervention formulation and change mechanisms will draw upon strategies for people who experience psychosis. Intervention strategies may include guided discovery, skills development, normalising and belief change strategies, including behavioural experiments targeting stigma-relevant appraisals and negative beliefs about self including public stereotypes of psychosis, and supporting decisions about whether to disclose. Control Condition The control condition will receive a two hour session receiving psychoeducation and normalising material relating to stigma in psychosis. The aim of the material is normalise experiences of psychosis and stigma. Information includes prevalence rates of psychosis, experiences of stigma and discrimination commonly reported by those who experience psychosis. Both interventions will be delivered by the same therapist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Behaviour Therapy for Internalised Stigma, Psychoeducation
Keywords
internalised stigma, self stigma, inpatients, CBT, Cognitive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioural therapy
Arm Type
Experimental
Arm Description
Cognitive behaviour therapy
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
psychoeducation
Intervention Type
Other
Intervention Name(s)
Cognitive Behaviour Therapy
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
Internalised stigma of mental illness scale
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Process of Recovery Questionnaire
Time Frame
5 minutes
Title
Beck Depression Inventory
Time Frame
5 minutes
Title
Beck Hopelessness Scale
Time Frame
5 mins
Title
Self-Esteem Rating scale
Time Frame
5 mins
Title
Attitudes towards mental health scale
Time Frame
5 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 Who meet criteria for a schizophrenia-spectrum diagnoses (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified; ICD-10) Able to give in-formed consent and have capacity to consent Receiving care from a clinical in-patient team Able to complete the interview in English Self-report being concerned about stigma Exclusion Criteria: Non-English speakers (due to translation costs) An acquired brain injury or substance misuse judged to be the acute cause of the psychotic experiences Lacking capacity for informed consent (the applicant will work with the participant to assess whether they understand the information sheet and study and therefore their ability to give informed consent) Experiencing severe thought disorder
Facility Information:
Facility Name
North east london foundation trust
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG3 8XJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Wood, DClinPsy
Email
lisa.wood@nelft.nhs.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
29494866
Citation
Wood L, Byrne R, Enache G, Morrison AP. A brief cognitive therapy intervention for internalised stigma in acute inpatients who experience psychosis: A feasibility randomised controlled trial. Psychiatry Res. 2018 Apr;262:303-310. doi: 10.1016/j.psychres.2017.12.030. Epub 2017 Dec 13.
Results Reference
derived

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A Study of an Cognitive Behaviour Therapy for Internalised Stigma Intervention for Inpatients With Psychosis

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