NCT04168918

Brief Summary

At the Psychiatric Hospital, there are limited mental health professionals to offer the standard of care that is expected at a psychiatric institution. Psychotherapy is most affected. However, there are mental health professionals in training and long waiting times before clients are seen, which provides an opportunity for an intervention to be carried out. The purpose of the study therefore, is to determine whether a group psychological intervention can primarily reduce self-stigma among outpatients at the Psychiatric Hospital. The intervention's effects on self-efficacy and quality of life will also be assessed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

17 days

First QC Date

November 14, 2019

Last Update Submit

May 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in self-stigma

    Mean Change from Baseline in scores on the Internalized Stigma of Mental Illness Inventory (ISMI) after 6 sessions Each item is scored 1-4 (1=strongly disagree;4=strongly agree), yielding a total between 29 and 116. Higher scores indicate greater self-stigma.

    From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (2)

  • Change in self-efficacy: General self-efficacy scale

    From enrollment to the end of intervention at 12 weeks

  • Change in quality of life: WHO5 Well Being Index

    From enrollment to the end of intervention at 12 weeks

Study Arms (2)

Group Psychological Intervention

EXPERIMENTAL

One topic will be discussed at each of the six sessions using some principles from cognitive behavioral therapy and psychoeducation.

Behavioral: Group psychological Intervention

Treatment-as-usual

NO INTERVENTION

Participants will receive their usual care which involves being seen by a mental health professional (psychologist, psychiatrist/resident in psychiatry, or mental health nurse).

Interventions

There will be 6 sessions covering 6 topics (Understanding mental disorders, Self-stigma, Social support, Substance use and mental illness, Self-help strategies, Available mental health services). Each session will begin with welcoming, reviewing what was done in the last session and home assignments (where applicable), question-guided discussion, lecture, group sharing and home assignment

Group Psychological Intervention

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attend clinic every 2 weeks
  • Willingness to attend all sessions

You may not qualify if:

  • Cognitive impairment that limits the participant from understanding material and answering questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Psychiatric Hospital

Bridgetown, Barbados

Location

Related Publications (4)

  • Cuhadar D, Cam MO. Effectiveness of psychoeducation in reducing internalized stigmatization in patients with bipolar disorder. Arch Psychiatr Nurs. 2014 Feb;28(1):62-6. doi: 10.1016/j.apnu.2013.10.008. Epub 2013 Oct 28.

    PMID: 24506989BACKGROUND
  • Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON, 1995

    BACKGROUND
  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PMID: 25831962BACKGROUND
  • Chang CC, Wu TH, Chen CY, Wang JD, Lin CY. Psychometric evaluation of the internalized stigma of mental illness scale for patients with mental illnesses: measurement invariance across time. PLoS One. 2014 Jun 2;9(6):e98767. doi: 10.1371/journal.pone.0098767. eCollection 2014.

    PMID: 24887440BACKGROUND

Study Officials

  • Shani KM Venner, MBBS,MPH

    University of the West Indies-Cave Hill Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Fifty per cent receive psychological intervention and fifty per cent receive treatment-as-usual
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 19, 2019

Study Start

January 7, 2020

Primary Completion

January 24, 2020

Study Completion

March 6, 2020

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations