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

Patrocinadores

Patrocinador principal: The University of The West Indies

Fuente The University of The West Indies
Resumen breve

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.

Descripción detallada

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

Estado general Not yet recruiting
Fecha de inicio December 2019
Fecha de Terminación March 2020
Fecha de finalización primaria March 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in self-stigma From enrollment to the end of intervention at 12 weeks
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 208
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Group psychological Intervention

Descripción: 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

Etiqueta de grupo de brazo: Group Psychological Intervention

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 69 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Shani KM Venner, MBBS,MPH Principal Investigator University of the West Indies-Cave Hill Campus
Contacto general

Apellido: Shani KM Venner, MBBS, MPH

Teléfono: (246)834-3087

Email: [email protected]

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: The University of The West Indies

Nombre completo del investigador: Shani Venner

Título del investigador: Postgraduate student

Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: Group Psychological Intervention

Tipo: Experimental

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

Etiqueta: Treatment-as-usual

Tipo: No Intervention

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

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Fifty per cent receive psychological intervention and fifty per cent receive treatment-as-usual

Propósito primario: Supportive Care

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov