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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853396
Recruitment Status : Unknown
Verified August 2016 by Lisa Wood, University of Manchester.
Recruitment status was:  Recruiting
First Posted : August 2, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Lisa Wood, University of Manchester

Tracking Information
First Submitted Date  ICMJE July 29, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date August 5, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Internalised stigma of mental illness scale [ Time Frame: 10 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Process of Recovery Questionnaire [ Time Frame: 5 minutes ]
  • Beck Depression Inventory [ Time Frame: 5 minutes ]
  • Beck Hopelessness Scale [ Time Frame: 5 mins ]
  • Self-Esteem Rating scale [ Time Frame: 5 mins ]
  • Attitudes towards mental health scale [ Time Frame: 5 mins ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of an Cognitive Behaviour Therapy for Internalised Stigma Intervention for Inpatients With Psychosis
Official Title  ICMJE A Pilot of a Brief Cognitive Behaviour Therapy Formulation Focused Intervention for Internalised Stigma With Acute Inpatients That Experience Psychosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cognitive Behaviour Therapy for Internalised Stigma
  • Psychoeducation
Intervention  ICMJE
  • Other: Cognitive Behaviour Therapy
  • Other: Psychoeducation
Study Arms  ICMJE
  • Experimental: Cognitive behavioural therapy
    Cognitive behaviour therapy
    Intervention: Other: Cognitive Behaviour Therapy
  • Active Comparator: Psychoeducation
    psychoeducation
    Intervention: Other: Psychoeducation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02853396
Other Study ID Numbers  ICMJE 16/NW/0332
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Wood, University of Manchester
Study Sponsor  ICMJE Lisa Wood
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Manchester
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP