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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

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.

Condition or disease Intervention/treatment Phase
Cognitive Behaviour Therapy for Internalised Stigma Psychoeducation Other: Cognitive Behaviour Therapy Other: Psychoeducation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot of a Brief Cognitive Behaviour Therapy Formulation Focused Intervention for Internalised Stigma With Acute Inpatients That Experience Psychosis
Study Start Date : July 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive behavioural therapy
Cognitive behaviour therapy
Other: Cognitive Behaviour Therapy
Active Comparator: Psychoeducation
psychoeducation
Other: Psychoeducation



Primary Outcome Measures :
  1. Internalised stigma of mental illness scale [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. Process of Recovery Questionnaire [ Time Frame: 5 minutes ]
  2. Beck Depression Inventory [ Time Frame: 5 minutes ]
  3. Beck Hopelessness Scale [ Time Frame: 5 mins ]
  4. Self-Esteem Rating scale [ Time Frame: 5 mins ]
  5. Attitudes towards mental health scale [ Time Frame: 5 mins ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853396


Locations
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United Kingdom
North east london foundation trust Recruiting
Ilford, Essex, United Kingdom, IG3 8XJ
Contact: Lisa Wood, DClinPsy       lisa.wood@nelft.nhs.uk   
Sponsors and Collaborators
Lisa Wood
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lisa Wood, Clinical Psychologist, University of Manchester
ClinicalTrials.gov Identifier: NCT02853396    
Other Study ID Numbers: 16/NW/0332
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Lisa Wood, University of Manchester:
internalised stigma
self stigma
inpatients
CBT
Cognitive therapy
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders