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

August 3, 2016 updated by: Lisa Wood

A Pilot of a Brief Cognitive Behaviour Therapy Formulation Focused Intervention for Internalised Stigma With Acute Inpatients That Experience Psychosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Internalised stigma of mental illness scale
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Process of Recovery Questionnaire
Time Frame: 5 minutes
5 minutes
Beck Depression Inventory
Time Frame: 5 minutes
5 minutes
Beck Hopelessness Scale
Time Frame: 5 mins
5 mins
Self-Esteem Rating scale
Time Frame: 5 mins
5 mins
Attitudes towards mental health scale
Time Frame: 5 mins
5 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Wood

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/NW/0332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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