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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 March 2019 |
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Main ID: |
ISRCTN17045085 |
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Date of registration:
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27/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of an inquiry-based stress reduction programme to reduce self-stigma in persons living with HIV and AIDS
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Scientific title:
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‘We are the change’ – an innovative community-based response to address self-stigma: a pilot study focusing on people living with HIV in Zimbabwe |
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Date of first enrolment:
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28/10/2013 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN17045085 |
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Study type:
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Interventional |
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Study design:
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Single-centre uncontrolled pilot study (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Stephen
Macdonald |
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Address:
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Irish Forum for Global Health, c/o Dept. of Epidemiology & Public Health Medicine
Royal College of Surgeons in Ireland
Beaux Lane House
Mercer Street Lower
Dublin 2
Dublin
Ireland |
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Telephone:
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Email:
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Affiliation:
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Name:
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Nadine
Ferris France |
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Address:
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The Work for Change
c/o Dept. of Epidemiology & Public Health Medicine
Royal College of Surgeons in Ireland
Beaux Lane House
Mercer Street Lower
Dublin 2
Dublin
Ireland |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Individuals living with a positive HIV diagnosis for longer than 3 months
2. Over 18 years of age
3. Able to speak English with sufficient fluency to take part in group discussions
4. Willing to provide informed consent and sign an informed consent form
Exclusion criteria:
1. Individuals with unknown HIV status
2. Individuals diagnosed with HIV in the last three months
3. Individuals currently undergoing psychotherapy treatment
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mental health: self-stigma, depression, and other mental states, among people living with HIV
Mental and Behavioural Disorders
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Intervention(s)
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Intervention name: 12-week programme incorporating Inquiry-based stress reduction (IBSR): The Work of Byron Katie.
Randomisation: None - all participants received the intervention.
Dose: weekly 3-hour sessions conducted by two facilitators trained and certified in IBSR; plus 15-45 minutes of individual or partner work carried out six days per week.
Duration: 12 weeks.
Intervention description: IBSR is a tool which helps users to identify, manage, and overcome negative thoughts such as shame, guilt, and other self-stigmatising beliefs.
Administration of the intervention: The experimental group participated in a 12-week programme combining facilitator-led sessions and individual or partner work. The IBSR intervention is a guided form of self-inquiry, where users are taught to recognise and perform deep self-inquiry about stressful and self-stigmatising thoughts, particularly around issues relating to living with HIV. Users appraise their thoughts using four key questions: 1) Is it true?; 2) Can I absolutely know that it is true?; 3) How do I react when I believe that thought?; and 4) Who would I be without the thought? By going through this process, users become more aware of self-stigmatising thoughts as they occur, and are able to work through them systematically, in order to better manage their emotional and psychological symptoms. The programme followed a curriculum based on the detailed core beliefs and issues identified in a previous study which focused on the underlying causes of HIV-related self-stigma, conducted among a diverse group of PLHIV in Dublin, Ireland, results of which were published in the Swiss Medical Weekly journal in 2015 (Ferris France et al. “An unspoken world of unspoken things”: a study identifying and exploring core beliefs underlying self-stigma among people living with HIV and AIDS in Ireland. Swiss Med Wkly. 2015;145:w14113. doi:10.4414
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Primary Outcome(s)
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1. HIV-related self-stigma, quantitatively measured using the Internalized AIDS-related Stigma Scale (IASS), a psychometric scale measuring six items reflecting self-defacing beliefs and negative perceptions of people living with HIV and AIDS. Focus group discussions and one-on-one interviews will also be used to capture more detail about changes arising due to the intervention. Timepoints: baseline, 1-monthfollow-up, 3-month follow-up
2. Self-reported psychological wellbeing, measured using the Ryff Scales of wellbeing. Focus group discussions and one-on-one interviews will also be used to capture more detail about changes arising due to the intervention. Timepoints: baseline, 1-month follow-up, 3-month follow-up
3. Depression, measured using the Center for Epidemiological Studies – Depression scale (CES-D). Timepoints: baseline, 1-month follow-up, 3-month follow-up
4. Quality of life, measured using the HIV/AIDS Targeted Quality of Life scale (HAT-QoL). Timepoints: baseline, 1 monthfollow-up, 3-month follow-up
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Secondary Outcome(s)
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Qualitative reporting by participants of changes to self-stigma and associated mental states following taking part in the intervention. This was measured using semi-structured focus group discussions and interviews at baseline, 1-monthfollow-up, and 3-month follow-up
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Secondary ID(s)
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IBSR-2013
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Source(s) of Monetary Support
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Trocaire
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Ethics review
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Status:
Approval date:
Contact:
Medical Research Council of Zimbabwe, 24/10/2013, ref: MRCZ/A/1782
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/08/2014 |
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URL:
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