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Trial registered on ANZCTR


Registration number
ACTRN12622000919718
Ethics application status
Approved
Date submitted
17/06/2022
Date registered
28/06/2022
Date last updated
31/01/2023
Date data sharing statement initially provided
28/06/2022
Date results information initially provided
31/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability, feasibility, and potencial efficacy of a multicomponent intervention on internalized stigma in people diagnosed with severe mental disorder.
Scientific title
Acceptability, feasibility, and potencial efficacy of a multicomponent intervention on internalized stigma in people diagnosed with severe mental disorder: a mixed pilot trial.
Secondary ID [1] 307379 0
None
Universal Trial Number (UTN)
U1111-1279-5070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
internalized stigma 326690 0
Condition category
Condition code
Mental Health 323933 323933 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Internalized Stigma Reduction Program: EncontrándoME, belonging to Igual-Mente: stigma reduction program, considers the levels at which stigma manifests itself. Interventions to reduce stigma and its typology should be by levels since the processes that generate and maintain it differ in each. Since a multilevel or ecological perspective was assumed in understanding stigma, the intervention's impact at the intrapersonal or individual level may have repercussions at other levels.
The interventions that served as the basis for the design of EncontrándoME were developed in high-income countries. For this reason, the activities from these interventions that were incorporated into the design of EncontrándoME were contextualized and adapted to the local reality, considering cultural values and meanings. Regarding the latter, what is threatened by stigma in the local context is the possibility of working and the feeling of usefulness that this generates in people with a mental disorder (MD). Therefore, the intervention considers the cultural aspects of mental disorders (MDs) and stigma.
Multiple interventional techniques were incorporated into account the integrative approach on which the intervention is based. Among them is narrative development, derived from narrative therapy, which has proven effective in getting individuals with MDs to create new stories that consider the challenges and positive aspects of their lives. Another technique is cognitive restructuring as part of cognitive-behavioral therapy, which was considered because it has been widely used to restructure negative beliefs about oneself and the MD. In addition, self-concept is addressed since it has been suggested that interventions should help individuals with hidden stigmatized identities to develop a positive self-concept. Training in coping strategies for stigma (education, deviance, and disclosure of MD) was incorporated since these are strategies that individuals with MDs have reported as valuable and effective. Finally, work will be done to enhance the recovery process of individuals with MDs because the more they are confident that recovery is possible and feasible, the less stigma will be internalized.
Regarding the materials used in the intervention, the facilitators have the administration manuals, pencils, markers, attendance sheets, labels to facilitate the identification of participants, cardboard cards, a ball, and a ball of yarn for the development of some activities, flip charts or a computer with a projector to present the content worked on in some sessions, as well as the certificates of participation that will be delivered at the end of the intervention. On the other hand, participants will be given a folder where they can keep the exercises and tasks of each session for later reference, as well as markers, pencils, erasers, crayons, glue, and scissors, in order to be able to carry out the exercises oriented in the sessions. A more detailed description of these materials can be found in the intervention administration manual for facilitators and co-facilitators.
Regarding the procedures, the intervention consists of 10 group sessions lasting 90 minutes each, administered to a group of 17 people once a week and in person (total duration: 2 months and 15 days). The number of sessions and their frequency are fixed. The intervention will take place in a room of the Family Mental Health Community Center (COSAM, for its acronym in Spanish) Leonor Mascayano (public health center belonging to primary care), located in Chile, Biobío Region, Concepción, so that it will take place in the same place as the recruitment of participants and data collection.
The sessions have a welcome, homework check, central activity/s, orientation to do the next week's homework, closing, and evaluation. Before each session, the facilitator should review the intervention administration manual and arrive 15 minutes early to set up the space and ensure everything is in order. He/she should set up the chairs in a circular fashion, test the equipment to be used and place the session materials on a table next to the work circle. At the beginning of each session, and as participants enter the meeting room, they should put on a name tag, which they will give to the facilitator at the end of each session to be used at the next session. Participants must complete a minimum of 7 sessions and fulfill the total number of hours required to obtain a certificate of participation at the end of the program (participants may only leave each session 10 minutes before the end of the program). The facilitator must send an email, WhatsApp, or phone call (previously agreed with each participant) one day before the session to remind them of their attendance. Likewise, the facilitator should call those participants who do not attend a session to give them a summary and encourage them to attend the next session. The intervention administration manual details the activities to be carried out in each session.
The intervention is administered by two facilitators (psychologist, psychiatrist, nurse, social worker, or other social science professional) with previous experience in group management and psychosocial interventions, as well as in working with individuals with MDs, which will be verified by direct consultation with the facilitators. An experienced expert in mental health (a person diagnosed with a mental disorder) will accompany the facilitators in two sessions. The facilitators and the experienced expert will receive prior training in the administration of the intervention by the responsible researcher, they will be recruited specifically for the study, and they will receive monetary compensation for developing the intervention (this compensation is not necessary to replicate the intervention). Training will be conducted face-to-face in a workshop format in the weeks before the administration of each session.
The intervention is planned to be tailored to the characteristics of the participants. This implies that the exercises for each session can be done in written form or through a drawing or collage. Two aspects will assess the fidelity of the intervention delivery; through the observation of each session, using a checklist by a professional external to the research team, and through a semi-structured interview with the facilitators one week after the end of the intervention. The checklists and the semi-structured interview are included in the intervention administration manual.
Intervention code [1] 323810 0
Treatment: Other
Intervention code [2] 323811 0
Rehabilitation
Intervention code [3] 323812 0
Behaviour
Comparator / control treatment
It will correspond to the usual treatment administered by the treating health team at the Family Mental Health Community Center (COSAM, for its acronym in Spanish). The usual treatment includes a follow-up consultation with the psychiatrist and one with the nurse to receive medication for psychiatric diagnosis, both once a month.
Control group
Active

Outcomes
Primary outcome [1] 331735 0
Changes in levels of internalized stigma as measured by the "Internalized Stigma of Mental Illness Scale".
Timepoint [1] 331735 0
Before the start of the first session of the intervention and after the last session of the intervention.
Secondary outcome [1] 410909 0
Changes in levels of self-esteem as measured by the "Rosenberg Self-Esteem Scale".
Timepoint [1] 410909 0
Before the start of the first session of the intervention and after the last session of the intervention.
Secondary outcome [2] 410910 0
Changes in levels of hopelessness as measured with the "Beck Hopelessness Scale".
Timepoint [2] 410910 0
Before the start of the first session of the intervention and after the last session of the intervention.
Secondary outcome [3] 410911 0
Changes in levels of recovery as measured by the "Recovery Assessment Scale".
Timepoint [3] 410911 0
Before the start of the first intervention session and after the last intervention session.
Secondary outcome [4] 410912 0
Changes in levels of empowerment as measured by the "Personal Empowerment Scale".
Timepoint [4] 410912 0
Before the start of the first intervention session and after the last intervention session.
Secondary outcome [5] 410913 0
Changes in identity characteristics associated with mental disorder as measured by the "Self and reflexive assessment scale of stigmatizing characteristics associated with the mental disorder identity".
Self and reflexive assessments scale be analysed together as a composite outcome. Both measure changes in identity characteristics associated with mental disorder.
Timepoint [5] 410913 0
Before the start of the first intervention session and after the last intervention session.
Secondary outcome [6] 410914 0
Perception of effectiveness of the interventional strategies as measured by the "Scale to assess the perception of effectiveness of the interventional strategies".
It was designed specifically for this study (4-point Likert scale).
Timepoint [6] 410914 0
After the last session of the intervention.

Eligibility
Key inclusion criteria
-Persons over 18 years of age.
-Persons with a diagnosis of TMG confirmed by the treating health team: Diagnoses of Schizophrenia; Schizotypal Disorder; Disorder of persistent delusional ideas; Disorder of induced delusional ideas; Schizoaffective Disorder; Non-organic psychosis; Non-organic psychosis without specification; Manic episode; Bipolar Disorder Type II; Major depressive episode with psychotic symptoms; Recurrent depressive disorder, a current severe episode with psychotic symptoms or other non-organic psychotic disorders, according to ICD-10.
-Clinically compensated according to the treating health team.
-Have more than one year of treatment in health centers for the current diagnosis.
-Capacity to consent assessed by a psychologist external to the treating health team using the Capacity for Treatment Assessment Tool (MacCAT-T).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Presence of organic deterioration indicated by the treating health team.
-Presence of comorbidity with substance abuse and dependence; does not include tobacco and alcohol, indicated by the treating health team.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Considering a design with a d=0.4, the number of participants per arm for the pilot trial should be 15 for 90% power and 5% bilateral significance in the final RCT. Considering that there could be a 10% eventual sample loss, 17 individuals will finally be selected for each arm.

A reflexive thematic analysis of the interviews will be carried out for qualitative data. For quantitative variables, the sociodemographic and clinical characteristics of the participants will be described using the mean and standard deviation for continuous variables and the raw value and percentage for categorical variables.
To respond to the primary and secondary objectives of the pilot trial, descriptive analyzes (mean, standard deviation, frequencies, proportions, percentages, and cut-off point analysis) and the estimation of the 95% confidence interval (CI) for the mean score difference.
The missing values will be declared, and the treatment given to them will be based on the multiple imputation methods. Intention-to-treat analysis of allocation effects will also be taken into account.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2022
Actual
20/09/2022
Date of last participant enrolment
Anticipated
Actual
5/10/2022
Date of last data collection
Anticipated
Actual
12/01/2023
Sample size
Target
34
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 24842 0
Chile
State/province [1] 24842 0
Bobío Region/Concepción

Funding & Sponsors
Funding source category [1] 311657 0
Government body
Name [1] 311657 0
National Agency for Research and Development (ANID SCHOLARSHIPS/NATIONAL DOCTORATE 21190228)
Country [1] 311657 0
Chile
Primary sponsor type
Individual
Name
Dany Fernández
Address
Universidad de Concepción, Faculty of Social Sciences, Psychology Department, Barrio Universitario s/n. Box 160-C, Mailbox 3, Concepción, Biobío, Chile. Postal code: 4030000.
Country
Chile
Secondary sponsor category [1] 313102 0
Individual
Name [1] 313102 0
Pamela Grandón
Address [1] 313102 0
Universidad de Concepción, Faculty of Social Sciences, Psychology Department, Barrio Universitario s/n. Box 160-C, Mailbox 3, Concepción, Biobío, Chile. Postal code: 4030000.
Country [1] 313102 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311113 0
Scientific Ethics Committee of the Health Service of Concepción
Ethics committee address [1] 311113 0
O´Higgins 297, Concepción, Biobío, Chile. Postal Code: 4030000.
Ethics committee country [1] 311113 0
Chile
Date submitted for ethics approval [1] 311113 0
Approval date [1] 311113 0
24/05/2022
Ethics approval number [1] 311113 0
CEC-SSC:21-06-31
Ethics committee name [2] 311114 0
Ethics, Bioethics and Biosafety Committee of the Vice-Rector for Research and Development of the University of Concepción
Ethics committee address [2] 311114 0
Barrio universitario s/n, Edificio Empreudec, Casilla 160 C – Correo 3, Concepción, Biobío, Chile. Postal Code: 4030000
Ethics committee country [2] 311114 0
Chile
Date submitted for ethics approval [2] 311114 0
Approval date [2] 311114 0
01/09/2020
Ethics approval number [2] 311114 0
CEBB 765-2020

Summary
Brief summary
The study seeks to evaluate a multicomponent pilot intervention's acceptability, feasibility, and potential effectiveness in reducing internalized stigma in people diagnosed with a severe mental disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119986 0
Mr Dany Fernández
Address 119986 0
Universidad de Concepción, Faculty of Social Sciences, Psychology Department, Barrio Universitario s/n. Box 160-C, Mailbox 3, Concepción, Biobío, Chile. Postal code: 4030000.
Country 119986 0
Chile
Phone 119986 0
+56412204301
Fax 119986 0
Email 119986 0
danfernandez@udec.cl
Contact person for public queries
Name 119987 0
Mr Dany Fernández
Address 119987 0
Universidad de Concepción, Faculty of Social Sciences, Psychology Department, Barrio Universitario s/n. Box 160-C, Mailbox 3, Concepción, Biobío, Chile. Postal code: 4030000.
Country 119987 0
Chile
Phone 119987 0
+56412204301
Fax 119987 0
Email 119987 0
danfernandez@udec.cl
Contact person for scientific queries
Name 119988 0
Mr Dany Fernández
Address 119988 0
Universidad de Concepción, Faculty of Social Sciences, Psychology Department, Barrio Universitario s/n. Box 160-C, Mailbox 3, Concepción, Biobío, Chile. Postal code: 4030000.
Country 119988 0
Chile
Phone 119988 0
+56412204301
Fax 119988 0
Email 119988 0
danfernandez@udec.cl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication; no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (danfernandez@udec.cl).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16404Study protocolFernández, D.; Grandón, P.; Bustos, C. (2023). A multicomponent intervention to reduce internalized stigma in persons with a diagnosis of severe mental disorder: protocol of a pilot randomized mixed trial. International Journal of Clinical Trials, 10(1), 45-55. DOI: 10.18203/2349-3259.ijct20230050https://www.ijclinicaltrials.com/index.php/ijct/article/view/642danfernandez@udec.cl



Results publications and other study-related documents

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