NCT02853396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

July 29, 2016

Last Update Submit

August 3, 2016

Conditions

Cognitive Behaviour Therapy for Internalised StigmaPsychoeducation

Keywords

internalised stigmaself stigmainpatientsCBTCognitive therapy

Outcome Measures

Primary Outcomes (1)

  • Internalised stigma of mental illness scale

    10 minutes

Secondary Outcomes (5)

  • Process of Recovery Questionnaire

    5 minutes

  • Beck Depression Inventory

    5 minutes

  • Beck Hopelessness Scale

    5 mins

  • Self-Esteem Rating scale

    5 mins

  • Attitudes towards mental health scale

    5 mins

Study Arms (2)

Cognitive behavioural therapy

EXPERIMENTAL

Cognitive behaviour therapy

Other: Cognitive Behaviour Therapy

Psychoeducation

ACTIVE COMPARATOR

psychoeducation

Other: Psychoeducation

Interventions

Cognitive Behaviour TherapyOTHER
Cognitive behavioural therapy
PsychoeducationOTHER
Psychoeducation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North east london foundation trust

Ilford, Essex, IG3 8XJ, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29494866DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 2, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

September 1, 2017

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

GB(1)