Psychotherapy Group for Parents of Children With Leber Congenital Amaurosis
Phase: NA
Conditions: Leber Congenital Amaurosis (LCA)
Sponsor: Instituto de Genética Ocular

Institute of Genetic Ocular in partnership with Retina São Paulo 
 
 
 
 
 
 
Psychosocial Aspects of Genetic Ocular Diseases 
 
 
 
 
 
 
Cecília Francini Cabral de Vasconcellos​
Advisor: Prof. Dr. Mariana Valim Salles 
 
 
 
 
São Paulo – july/2024 

ABSTRACT​
Genetic ocular diseases are a heterogeneous group of hereditary diseases that 
cause substantial vision loss at various age ranges. In addition, there may be 
syndromic cases that affect other systems such as the skeletal and vestibular 
systems. The literature indicates that individuals affected by genetic ocular diseases 
have low quality of life and high rates of depression. They tend to have high 
healthcare costs, and their caregivers often leave the workforce. Therefore, the 
objective of this study is to investigate the psychosocial aspects of individuals with 
genetic ocular diseases, their family members, and caregivers. 
Keywords: psychosocial aspects; genetic ocular diseases; psychotherapy; 
emotional health; family relationships; 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Introduction​
Ocular genetics is a specialized field within ophthalmology that focuses on the study 
and treatment of ocular diseases of genetic origin, known as genetic eye diseases 
(GED), which can be transmitted through different hereditary patterns, such as 
autosomal recessive, autosomal dominant, X-linked, or mitochondrial (BERGER; 
KLOECKENER-GRUISSEM; NEIDHARDT, 2010; HAIM, 2002).​
Among the most common GEDs are Hereditary Retinal Dystrophies (IRD), a 
heterogeneous group of conditions that cause degenerative and functional changes 
in the retina (BERGER; KLOECKENER-GRUISSEM; NEIDHARDT, 2010). These 
include Stargardt disease (STGD), retinitis pigmentosa (RP), Usher syndrome (US), 
and Leber congenital amaurosis (LCA), affecting approximately 1 in 4,000 
individuals.​
STGD, for example, is a macular dystrophy that typically begins in adolescence or 
early adulthood, leading to gradual central vision loss. RP, initially characterized by 
night blindness, progressively limits the individual's visual field (BESSANT; ALI; 
BHATTACHARYA, 2001; HAIM, 2002). The syndromic form of RP, associated with 
hearing loss, is called US. LCA, in turn, is considered the most severe form of IRD, 
affecting both central and peripheral vision from the first months of life.​
So far, there is no cure for GED, except for gene therapy developed to treat LCA 
caused by a mutation in the RPE65 gene (NASH et al., 2015; SAHELI; MARAZOVA; 
AUDO, 2015; RUSSELL et al., 2017). In addition to IRDs, other GEDs include 
Marfan syndrome, which affects multiple body systems, and Knobloch syndrome, 
characterized by high myopia, retinal detachment, and brain abnormalities 
(SALLUM; CHEN; PEREZ, 2002; LI et al., 2021).​
Patients with GED experience low quality of life and also have high rates of anxiety 
and depression. This is due to the lack of social understanding of their condition and 
the challenges in adapting to vision loss. Vision loss can be considered a grieving 
process, as the loss of sight represents the death of a sense. This grief process, 
combined with a decrease in quality of life, makes it increasingly difficult for GED 
patients to experience psychological well-being (HAMBLION; MOORE; RAHI, 2011; 
NASCIMENTO et al., 2015; DEAN et al., 2017; ANIL; GARIP, 2018; TAIPALE et al., 
2019; GALVIN et al., 2020; KUMAR, 2023).​
Family members, parents, and caregivers also suffer psychosocial impacts related to 
GED. They also experience high levels of anxiety and depression and low quality of 

life. Additionally, they struggle to maintain financial health and are often 
overwhelmed by the care required for patients with GED.​
The psychosocial impacts of GED vary depending on an individual's life history and 
emotional resources, requiring different forms of support such as psychotherapy, 
psychiatry, and rehabilitation (NASCIMENTO et al., 2015; DEAN et al., 2017; 
TAIPALE et al., 2019; KUMAR, 2023).​
Psychotherapy can help patients in accepting visual impairment and developing 
coping strategies for their condition. There are adaptive coping strategies, which aim 
to solve challenges and regulate emotions, and maladaptive coping strategies, which 
avoid or escape obstacles without regulating the emotions arising from them 
(GARIP; KAMAL, 2019).​
One of the current psychotherapeutic approaches is Acceptance and Commitment 
Therapy (ACT). ACT is considered a third-wave cognitive-behavioral therapy rooted 
in functional contextualism and relational frame theory (HAYES, 2004; RUIZ, 2012). 
It has six core principles that guide its interventions: 
1.​ Psychological Acceptance: A conscious process of accepting unpleasant 
events that are inevitable, meaning that there is no denial of the situation, but 
rather the realization that it is necessary to experience difficult situations, 
thoughts, and feelings to accept and learn to deal with them. 
2.​ Cognitive Defusion: The process of distancing oneself from cognitive fusion. 
Cognitive fusion is a state in which a person is fused with their thoughts and 
feelings, believing them to be facts of reality. 
3.​ Contact with the Present Moment: Thinking clearly about things that are 
happening in the present moment, identifying thoughts and interpretations as 
subjective psychological events. 
4.​ Self-as-Context: The process of understanding that a person changes with 
every new experience. There is a rigidity in seeing the individual as something 
static, but individuals constantly evolve. 
5.​ Committed Actions: The act of behaving consciously, committing to one's 
values regardless of external reality. 
6.​ Values: Qualities of actions that individuals believe are appropriate in any 
situation in life, such as honesty, justice, and charity.​
ACT has proven effectiveness in individual therapy for various psychiatric 

disorders and chronic illnesses (MANGIONE et al., 2001; CASTRO et al., 
2006). Additionally, it has shown effectiveness in group therapy, where 
interventions typically focus on a theme related to the group's suffering, and 
these interventions usually involve a specific number of sessions, ranging 
from 8 to 20 (SIMÃO et al., 2008; SANTOS et al., 2011).​
The literature indicates that ACT in groups is effective in improving emotional 
health for groups suffering from anxiety and depression, domestic violence, 
chronic illness in children, and substance abuse (SIMÃO et al., 2008; 
SANTOS et al., 2011).​
No data was found in the literature regarding ACT psychotherapy for people 
with visual impairment. However, other psychosocial interventions have 
already been conducted. A systematic review and meta-analysis evaluated 
interventions to improve emotional health, anxiety, depression, and loneliness 
in adults with visual impairment. The results indicated that interventions 
significantly reduced depressive symptoms, but did not improve anxiety, 
psychological stress, or loneliness (VAN DER AA et al., 2016).​
There were also no studies investigating psychotherapeutic interventions for 
parents of children with LCA, but one study conducted a two-day Acceptance 
and Commitment Therapy (ACT) workshop with parents of children with ASD. 
This training, based on the six pillars of ACT, led to improvements in the 
parents' emotional health and reduced experiential avoidance (HAYES; 
STROSAHL; WILSON, 1999; BLACKLEDGE; HAYES, 2006). 
 
Justification​
As mentioned above, GED directly impacts the quality of life of those affected 
(HAHM et al., 2008; HAMBLION et al., 2011; DEAN et al., 2017; NASCIMENTO et 
al., 2015; TAIPALE et al., 2019; GALVIN et al., 2020; KUMAR, 2023). Their physical 
health is compromised by alterations with no cure or treatment. Their emotional 
health is drastically affected by anxiety and depression. Their social relationships 
may be reduced or altered, as these individuals may not be understood in terms of 
their limitations. Furthermore, society's structure is not adequately accessible to 
meet the needs of people with GED (BUCKMAN, 1984; LATHAM et al., 2015).​

Given the impacts listed above, it is evident that investigating the psychosocial 
aspects of this population is crucial. Understanding how socially unadapted they 
might be and the extent of their psychological distress will lead to the creation of 
public policies aimed at improving the quality of life for this group.​
Living without quality of life and psychological well-being can accelerate physical 
health deterioration for individuals with GED, further emphasizing the need for a 
comprehensive 
evaluation 
of 
these 
individuals 
(SALLUM 
et 
al., 
2002; 
CHAUMET-RIFFAUD et al., 2017; LI et al., 2021). This should be approached from 
medical, psychological, and social perspectives. The best care for individuals with 
GED is holistic care.​
Lastly, family members and caregivers of individuals with GED also suffer various 
psychosocial impacts due to their direct connection with these patients. This 
population is not widely studied, and new research shedding light on their reality 
could lead to ways of mitigating the impacts on their psychological well-being. 
Hypothesis 
The hypothesis of this study is that individuals with genetic eye diseases 
(GED) and their families experience high levels of anxiety and depression, as well as 
low quality of life. It is believed that during medical consultations, these patients 
report difficulties in dealing with the disease, its genetic aspects, and the adaptation 
to a life with visual impairment. 
Psychotherapy groups are known to produce significant results in improving 
the quality of life of patients with anxiety, depression, or chronic pain. Based on 
interventions tailored for the GED population, it can be assumed that psychotherapy 
will improve the quality of life and emotional health of these patients and their 
families. 
 
Objective 
General: 
To assess the psychosocial impacts of GED on patients, family members, and 
caregivers. 
 
Specific: 
 

●​ Investigate anxiety and depression in patients with GED (study 1) 
●​ Review medical records of patients with GED (study 2) 
●​ Evaluate the effect of a psychotherapy group for adults with GED on quality of 
life and emotional health (study 3) 
●​ Evaluate the effect of a group psychotherapy intervention for parents of 
children/adolescents with LCA on indicators of emotional health, parental 
stress, acceptance, cognitive defusion, and mindfulness (study 4) 
●​ Evaluate the effect of a psychotherapy group for family members of 
individuals with GED on quality of life and emotional health (study 5) 
 
Method 
Prospective cross-sectional and longitudinal study and medical record review. 
 
Sample 
The sample for the assessment of anxiety and depression will be obtained through 
convenience sampling, in contact with patients from the Instituto de Genética Ocular 
and Retina Brasil, with the aim of including patients with multiple conditions for a 
better understanding of the impact of each disease on anxiety and depression (study 
1). The medical records to be reviewed will be those that involved joint care between 
psychologist and counselor (study 2). For the psychotherapy groups, the sample will 
be drawn from the interest of patients and family members in participating (study 3, 
4, 5). Additionally, forty parents of children and adolescents with LCA will be 
included. Twenty will participate in psychotherapy groups, and twenty will be in the 
control group.  
 
Inclusion Criteria 
●​ Patients over 18 years old diagnosed with any disease leading to visual 
impairment 
●​ Parents and family members over 18 years old of individuals with GED 
Exclusion Criteria 
●​ Children and adolescents with visual impairment 
●​ Patients without a conclusive diagnosis of GED 
 

Instruments 
 
Hospital Anxiety and Depression Scale (HADS) 
The HADS questionnaire was validated and translated into Portuguese (ZIGMOND; 
SNAITH, 1983; ZIGMOND; SNAITH, 1986; CASTRO et al., 2006). It consists of two 
subscales: the HADS Anxiety Scale (HADS-A) and the HADS Depression Scale 
(HADS-D). Each of the 7 anxiety questions and 7 depression questions is scored on 
a four-point scale (0-3), with final scores ranging from 0 to 21 for each subscale. The 
presence of anxiety or depression symptoms is classified as absent for scores below 
7, possible between 8 and 10, and probable for scores above 11. 
 
National Eye Institute – Vision Functioning Questionnaire 25 (NEI-VFQ 25) 
The NEI-VFQ-25 is an instrument validated for the Brazilian population that 
evaluates vision-related quality of life. It contains 25 items covering the following 
domains: general health status (1 item); overall vision (1 item); eye pain (2 items); 
difficulty with near vision activities (3 items); difficulty with distance vision activities (3 
items); limitations in social functioning due to vision (2 items); mental health 
problems due to vision (4 items); functional limitations due to vision (2 items); 
dependence on others due to vision (3 items); driving difficulties (2 items); difficulty 
with color vision (1 item); and difficulty with peripheral vision (1 item). Each subscale 
score is converted to a score between 0 to 100, with higher scores indicating better 
quality of life. (MANGIONE et al., 2001; SIMÃO et al., 2008) 
 
Self-Reporting Questionnaire (SRQ-20) 
The SRQ-20 was validated for the Brazilian population and contains 20 items 
assessing the presence of mental disorders. The questions are scored 
dichotomously, and a score of 7 points or higher indicates the presence of a mental 
disorder. The SRQ-20 serves as a screening tool but does not identify the specific 
mental disorder experienced by the patient. (SANTOS et al., 2011) 
 
Freiburg Mindfulness Inventory (FMI) 
The FMI assesses mindfulness through 14 questions. It was validated for the 
Brazilian population and is self-reported. Each question is answered on a Likert 

scale from 1 to 4. Higher scores indicate greater alignment with mindfulness 
practices. (HIRAYAMA et al., 2014) 
 
Parental Stress Scale (EEPa) 
The EEPa was validated and adapted for Brazil and contains 16 items, with eight 
related to parents’ satisfaction with their parenting experience and eight related to 
parental stressors. Responses are made on a Likert scale, ranging from 0 (strongly 
disagree) to 4 (strongly agree). The total score is 64 points, and the higher the score, 
the greater the parental stress experienced by the participants. (BRITO; FARO, 
2017) 
 
Ethical Aspects 
Data for study 1 will be collected through a questionnaire on the Google Forms 
platform. In order to complete it, the patient must read, consent, and agree to the 
Informed Consent Form for Research in a Virtual Environment (TCLE) (Annex 1). 
For study 2, patients will be contacted for consent to review their medical records. 
The records can only be reviewed after the completion of the Informed Consent 
Form. 
For studies 3, 4, and 5, patients wishing to participate in the psychotherapy group 
process must also read, consent, and agree to the Informed Consent Form in a 
Virtual Environment. If a participant withdraws from the research, they may continue 
with the psychotherapy process. 
Participants may withdraw their data from the study at any time without providing a 
reason. The data collected will be used exclusively for the purposes of this research. 
Procedures​
To assess anxiety and depression in the GED population, a Google Forms 
questionnaire will be distributed through the social media channels of the Instituto de 
Genética Ocular and Retina Brasil over a 3-month period. Participants will be invited 
to join and will accept the consent form attached to the form itself (study 1).​
The medical record review will be based on the collection of appointments between 
the medical advisor and the psychologist. The necessary data will be extracted from 
the medical records, and each case will be evaluated by the responsible parties for 
potential inclusion in the sample (study 2).​

For studies 3, 4, and 5, participants will be invited via social media at the beginning 
of each semester. Interested patients will be screened by the responsible 
psychologists, and a battery of tests will be conducted for the initial evaluation. 
Afterward, 3 months of weekly psychotherapy groups, each lasting 1.5 hours, will 
take place. At the end of the group and two months after its conclusion, the same 
questionnaires will be administered to reassess the patients. 
Data Processing and Analysis​
For the data of each evaluation, the stages of acquisition, organization, cleaning, 
processing, and preparation for statistical analysis will be carried out according to the 
specifics of the method used.​
The data will be compiled and analyzed using IBM® SPSS Statistics (version 2.7), 
and descriptive statistical analyses will be performed to check the means, standard 
deviations, and the Shapiro-Wilk test to verify normal distribution. If other statistical 
tests are necessary, they will be conducted. 
Primary Outcome​
Study 1: Determine the rates of anxiety and depression in the GED population.​
Study 2: Understand the main psychosocial issues related to GED in ophthalmology 
consultations.​
Studies 3, 4, and 5: Evaluate the effect of psychotherapy groups on the emotional 
health and quality of life of family members and parents of people with GED. 
Secondary Outcome​
Study 1: Investigate the relationship between anxiety and depression and the degree 
of disability, time of diagnosis, productive life, and rehabilitation.​
Study 2: Identify potential interventions for negative emotional aspects perceived in 
consultations for people with GED.​
Studies 3, 4, and 5: Understand the emotional aspects of parents and family 
members of people with GED and reflect on other possible interventions. 
Risks and Benefits​
The risks of this research are minimal. Anxiety and depression questionnaires may 
trigger unpleasant memories for the patients. As for the authorization for medical 
record review, it is believed that there will be no significant impact on individuals with 

GED. Regarding the psychotherapy groups, contact with the patient's emotional 
suffering may also occur.​
For both questionnaire administration and psychotherapy groups, patients will be 
evaluated and supported by the responsible psychologist, and any additional distress 
will be addressed individually.​
The benefits of this research are numerous. By understanding the rates of anxiety 
and depression in the GED population, it will be possible to consider public policies 
aimed at improving these conditions. Understanding the main topics discussed in 
medical consultations can help create guidelines to serve this population. 
Psychotherapy groups may significantly improve participants' psychological 
well-being and quality of life. 
Return of Benefits to the Studied Population​
All data collected in this study will shed light on the psychosocial condition of people 
with GED and will assist in planning care for this population in different institutions. 
Moreover, it will contribute to the development of public policies based on real data 
about the characteristics of people with GED. 
Detailed Financial Budget and Compensation​
There will be no costs associated with conducting this research. The principal 
researchers will not be compensated, and there will be no need for resource 
allocation. 
Timeline 
Activities 
Period 
Approval by the Ethics Committee  
September to November 2024 
Sample Selection 
November 2024 to February 2025 
Data Collection 
February 2025 to February 2027 
Analysis, 
Description, 
and 
Discussion 
February 2027 to July 2028 
Conclusion 
July to September 2028 

 
 
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