Study Stopped
Most participants did not complete the post-intervention questionnaire
Effectiveness of a Group Psychological Intervention in Reducing Self-stigma Among Patients With Mental Disorders
Efficacy of a Group Psychological Intervention in Reducing Self-Stigma Among Outpatients at the Psychiatric Hospital: A Randomized Controlled Trial
1 other identifier
interventional
52
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
January 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2020
CompletedMay 21, 2021
May 1, 2021
17 days
November 14, 2019
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
EXPERIMENTALOne topic will be discussed at each of the six sessions using some principles from cognitive behavioral therapy and psychoeducation.
Treatment-as-usual
NO INTERVENTIONParticipants 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
Eligibility Criteria
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
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: 24506989BACKGROUNDSchwarzer 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
BACKGROUNDTopp 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: 25831962BACKGROUNDChang 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
- PRINCIPAL INVESTIGATOR
Shani KM Venner, MBBS,MPH
University of the West Indies-Cave Hill Campus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- 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