Skip to content

Acceptability, feasibility, and potencial efficacy of a multicomponent intervention on internalized stigma in people diagnosed with severe mental disorder.

Acceptability, feasibility, and potencial efficacy of a multicomponent intervention on internalized stigma in people diagnosed with severe mental disorder: a mixed pilot trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000919718
Enrollment
34
Registered
2022-06-28
Start date
2022-09-20
Completion date
2022-10-05
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 interven

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.

Sponsors

Dany Fernández
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026