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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Self Efficacy; Self-stigma
• Intervention / Treatment: Behavioral: Group psychological Intervention

Detailed Description

Study population: outpatients in the Outpatient Department at The Psychiatric Hospital

Target population: clients with two-weekly appointments

Procedures for recruitment and consent

Participants will be chosen using available lists of persons who come to clinic on a two-weekly basis on four(4) days of the week (every day except the day the Principal Investigator is responsible for conducting clinic), for two consecutive weeks. Twenty-six will be chosen each day (for eight (8) days) and randomized to intervention and treatment-as-usual (Thirteen (13) persons to each group). Participants will be selected based on the inclusion and exclusion criteria and consent will be obtained.

Randomization will be carried out by Stata 14

Sample size

Using the means and standard deviations for the Internalized Stigma of Mental Illness Inventory (ISMI) used in a randomized controlled trial and Stata 14 for sample size calculation, the sample size recommended is eighty-four (84) with forty-two (42) per group. This will give a power (for the study) of eighty per cent (80%).

However, the aim will be two-hundred and eight (208) clients based on the following:

• Target population: two-hundred and fifty (250). Approximately twenty-five (25) patients come to clinic daily, most of whom come on a two-weekly basis. Therefore, this will allow eighty-three per cent (83%) of the population to be part of the study.
• Maximum number of persons in a group- thirteen (13)
• Maximum number of groups that can be held before clinic begins- one (1)
• Time for thesis
• Taking into account that persons may not be willing to participate and so aiming to include as many persons as possible

Method

There will be six (6) sessions covering six (6) topics. One topic will be covered at each session. Sessions will last sixty (60) to ninety (90) minutes.

Data collection

- Administration of the ISMI, the General self-efficacy scale and World Health Organization (WHO)5 Well Being Index and a questionnaire to the intervention and control groups before the intervention and after the intervention. This will be done by a health professional not related to the study.

Permission was obtained from producer of ISMI. WHO5 Well-Being Index is free to use and General self-efficacy scale does not require permission, once referenced.

All three scales have been found to be valid and reliable.

• A pilot study on 26 persons will be conducted to test the questionnaire and scales.
• To ensure accurate completion of questionnaire and scales by each participant, each item will be read and explained before participants asked to select answer. Questions on clarification will be encouraged.Time will also be given after, for participants to read through answers if needed. Additionally, when collecting questionnaires and scales, the mental health professional will scan through to ensure all questions answered.

Questionnaires and scales will be identified using participants' record numbers to facilitate verification of information such as whether medications or health care provider changed during the course of the intervention.

Statistical analyses

• Summary statistics
• Regression analysis of endpoint score adjusting baseline score and looking at the difference between the intervention and treatment-as-usual groups.

Intention to treat analysis will be used.

- Software to be used: Stata 14 Missing entries will be included in the analysis Data handling and record keeping

Questionnaires kept in secure room for at least five (5) years

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Barbados
  • Bridgetown, Barbados
    • The Psychiatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Psychological Intervention; One topic will be discussed at each of the six sessions using some principles from cognitive behavioral therapy and psychoeducation.	Behavioral: Group psychological Intervention; 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
No Intervention: Treatment-as-usual; Participants will receive their usual care which involves being seen by a mental health professional (psychologist, psychiatrist/resident in psychiatry, or mental health nurse).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-efficacy: General self-efficacy scale	Mean Change from Baseline in scores on the General self-efficacy scale after 6 sessions Each item is scored 1-4 (1=not true at all; 4=exactly true) yielding a total between 10 and 40. Higher scores indicate more self-efficacy	From enrollment to the end of intervention at 12 weeks
Change in quality of life: WHO5 Well Being Index	Mean Change from Baseline in scores on the WHO5 Well Being Index after 6 sessions Each item is scored 0-5 (0=at no time; 5=all of the time) yielding between 0 and 25. Higher scores indicate better quality of life.	From enrollment to the end of intervention at 12 weeks

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Shani KM Venner, MBBS,MPH, University of the West Indies-Cave Hill Campus

Publications and helpful links

General Publications

• 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.
• 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 191002-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No