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

Psychoeducation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853396
• Other study ID #: 16/NW/0332
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 3, 2016
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2016
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Behaviour Therapy for Internalised Stigma
• Psychoeducation

Intervention

Other:
• Cognitive Behaviour Therapy

• Psychoeducation

Locations

Country	Name	City	State
United Kingdom	North east london foundation trust	Ilford	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Lisa Wood

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internalised stigma of mental illness scale		10 minutes	No
Secondary	Process of Recovery Questionnaire		5 minutes	No
Secondary	Beck Depression Inventory		5 minutes	No
Secondary	Beck Hopelessness Scale		5 mins	No
Secondary	Self-Esteem Rating scale		5 mins	No
Secondary	Attitudes towards mental health scale		5 mins	No