Condition category
Mental and Behavioural Disorders
Date applied
12/09/2017
Date assigned
27/09/2017
Last edited
27/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Self-stigma, which generally involves negative self-judgements resulting in shame, worthlessness and self-blame, can cause damaging emotional distress among people living with HIV and other chronic illnesses. It also can harm a person's self-agency, quality of life, adherence to treatment, and access to services. Despite the widespread prevalence of self-stigma in many countries, there are relatively few interventions to address it. The aim of this study is to examine the potential role of a programme incorporating “Inquiry-Based Stress Reduction (IBSR): The Work of Byron Katie” in helping people living with HIV to overcome self-stigma and associated mental states.

Who can participate?
Adults aged 18 or over, living with a positive HIV diagnosis for longer than 3 months, and able to speak English fluently enough to take part in group discussions

What does the study involve?
The participants attend a 12-week programme using Inquiry-based stress reduction (IBSR): The Work of Byron Katie. This consists of weekly 3-hour sessions conducted by two trained and certified IBSR facilitators, plus 15-45 minutes of individual or partner work carried out six days per week. Participants are taught to recognise and perform deep self-inquiry about stressful and self-stigmatising thoughts, particularly around issues relating to living with HIV. They are taught to 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? The participants learn to become more aware of self-stigmatising thoughts as they occur, and to work through those thoughts systematically in order to better manage their emotional and psychological symptoms.

What are the possible benefits and risks of participating?
Possible benefits to participants are the reduction in self-stigma and associated negative mental states. Due to the deep self-inquiry performed as part of the intervention, there is the risk that participants need to revisit painful memories and recount past traumas. Any potential mental harm arising from this is mitigated by the techniques used in the intervention.

Where is the study run from?
The intervention takes place at the CONNECT Zimbabwe Institute of Systemic Therapy in Harare, Zimbabwe, with research support from the Royal College of Surgeons in Ireland, in Dublin, Ireland, and Impact Research International in Harare, Zimbabwe, and Pretoria, South Africa.

When is the study starting and how long is it expected to run for?
February 2014 to August 2014

Who is funding the study?
Trocaire (Ireland)

Who is the main contact?
1. Dr Stephen Macdonald
2. Ms Nadine Ferris France

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Macdonald

ORCID ID

Contact details

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
Dublin 2
Ireland

Type

Public

Additional contact

Ms Nadine Ferris France

ORCID ID

Contact details

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
Dublin 2
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IBSR-2013

Study information

Scientific title

‘We are the change’ – an innovative community-based response to address self-stigma: a pilot study focusing on people living with HIV in Zimbabwe

Acronym

Study hypothesis

A psychosocial intervention utilising techniques of Inquiry-Based Stress Reduction (IBSR): The Work of Byron Katie, could influence levels of self-stigma, and other associated mental states such as depression, among a group of people living with HIV.

Ethics approval

Medical Research Council of Zimbabwe, 24/10/2013, ref: MRCZ/A/1782

Study design

Single-centre uncontrolled pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mental health: self-stigma, depression, and other mental states, among people living with HIV

Intervention

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/smw.2015.14113).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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-week follow-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-week follow-up, 3-month follow-up
3. Depression, measured using the Center for Epidemiological Studies – Depression scale (CES-D). Timepoints: baseline, 1-week 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-week follow-up, 3-month follow-up

Secondary outcome measures

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-week follow-up, and 3-month follow-up

Overall trial start date

03/06/2013

Overall trial end date

30/08/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

20 participants

Participant exclusion criteria

1. Individuals with unknown HIV status
2. Individuals diagnosed with HIV in the last three months
3. Individuals currently undergoing psychotherapy treatment

Recruitment start date

28/10/2013

Recruitment end date

21/02/2014

Locations

Countries of recruitment

Zimbabwe

Trial participating centre

Connect Zimbabwe Institute of Systemic Therapy (CONNECT ZIST)
18149 Ganges Road Ridgeview Belvedere
Harare
-
Zimbabwe

Sponsor information

Organisation

Royal College of Surgeons in Ireland Department of Epidemiology and Public Health Medicine

Sponsor details

Beaux Lane House
Mercer Street Lower
Dublin
Dublin 2
Ireland

Sponsor type

University/education

Website

http://rcsi.ie/

Organisation

Impact Research International

Sponsor details

10 Clara Road
Marlborough
Harare
Zimbabwe
Zimbabwe

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Trocaire

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of 1-week and 3- month follow-ups were submitted for publication as a single academic article which the trialists aim to publish in Q4 2017. Further analysis of the data may yield information which allows a second article to be published.

IPD sharing statement
Anonymised quantitative data from surveys of participants will be made available as supporting material to accompany publications. However, qualitative data is derived from confidential interviews and focus groups. In line with the personal nature of these discussions, and the terms of informed consent to which participants agreed, the full transcripts will not be made available. Illustrative verbatim quotes will included in published articles where necessary to support the findings of the analysis. Transcripts are held securely by the research team at CONNECT Zimbabwe Institute of Systemic Therapy, and will only be made available, with prior agreement, in the event that audit is necessary.

Intention to publish date

21/10/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes