Psychological needs and support among patients and families undergoing food oral immunotherapy

Abstract Background Oral immunotherapy (OIT) is a promising treatment for food allergy (FA) however it is a challenging process for patients and parents. Induction can generate stress and anxiety. This may in turn affect their motivation and ability to cope with OIT challenges. Objective This study aimed to investigate psychological needs and support to patients/parents undergoing food OIT assessing participants' main characteristics, reasons for seeking psychological support, OIT phase and related psychological difficulties, type and timing of treatments and patients' perception of the effectiveness of the intervention. Methods This is an observational, retrospective study. 50 psychological interventions required for OIT related problems were selected consecutively in a Referral Centre in North‐Eastern Italy. All patients had a medical diagnosis of FA and were undergoing OIT or had just discontinued it. Data were collected from hospital records. A descriptive statistical analysis was performed. Results 66% of patients asked for psychological support for the initial phase (e.g., oral food challenge, first maintenance doses), 20% during the up‐dosing phase, 8% during maintenance and 6% after discontinuation. 70% of treatments were required mainly because of emotional problems including dysfunctional anxiety and mood disorders, increased distress and excessive worry and/or fear related to OIT; 20% because of difficulties in managing OIT; 10% because of eating difficulties; 50% of patients reported recent anaphylaxis. All patients reported improvement and felt the psychological intervention was helpful. Conclusion It is recommended to evaluate the psychological needs in profiling patients and families suitable to OIT and offer specific psychological support when needed.


| METHODS
This is an observational, retrospective study. The reasons why patients asked for psychological support were analysed and assigned to three categories: emotional problems (we used this 'umbrella' term to describe a diverse array of clinically significant symptoms and syndromes in which some kind of emotional alteration is involved such as dysfunctional anxiety and mood disorders, increased distress and excessive worry and/or fear), 8 compliance, eating difficulties. Patients' perception of the effectiveness of treatments was measured through an adaptation of the additional follow-up questions of the Strengths and Difficulties Questionnaire of Goodman for use after an intervention (available at http://www.sdqinfo.com/) as done in a previous publication. 9 The study was performed in accordance with the European regulation regarding potential sensitive data and has been approved by the Padua University Hospital Ethics Committee. Authors intentionally avoided reporting detailed information about patients to guarantee anonymity and confidentiality.

| RESULTS
From October 2013 to October 2019, 303 patients approached OIT. Of these, 55 (18%) were referred to the psychologist for difficulties related to the therapy. Among the latter, 50 (91%) undertook psychological treatment and constituted the sample of this study. They represent 16.5% of all patients who have undergone OIT in the considered period. In the sample 66% sought psychological care spontaneously, while 34% did it following the allergist's suggestion.
All participants came from North Italy and were White. They had a mean age of 18.02 (Standard Deviation 12.98); 66% were females, 8% came from a low-income family, 6% had previous psychiatric comorbidity, 70% had multiple FA, 50% reported a recent anaphylaxis, all had adrenaline auto-injector prescription.
Overall, out of a total of 50 interventions, 36% were addressed to the whole family (patient undergoing OIT and parents), 26% to teenagers, 16% to patients' mothers, 14% to children and 8% to adults, as showed in Table 2. Concerning to the OIT phase, 66% of patients asked for psychological support for the initial phase (e.g., OFC, first doses of maintenance at home), 20% during the up-dosing phase, 8% during maintenance and 6% after discontinuation due to reactions ( Figure 1). With regards to the reason why patients asked for psychological support (Figure 2), 70% of treatments were required mainly because of emotional problems including dysfunctional anxiety, distress and mood disorders, excessive worry and/or fear related to OIT. Moreover 20% of treatments were held because of difficulties in managing OIT that included inadequate compliance and/or maladaptive coping strategies. 10% of the requests were expressed because of eating difficulties (excessive diffidence or disgust toward food) that interfered with the assumption of OIT foods. In two cases, after the psychological consultation it was agreed with the patient/ parents and the medical staff not to start the OIT. Seven patients who were hesitant about starting OIT decided to start the treatment after psychological consultation. Five patients, who thought to drop out, decided to continue after psychological intervention.
With regard to type and timing of treatments, 52% of treatments consisted of psychological support (talk therapy, brief cognitive behavioural therapy [CBT], relaxation treatment -for example Jacobson Progressive Muscle Relaxation) 10

-and Guided
Affective Imagery (GAI), 11 38% counselling and psychoeducation, 10% psychotherapy (CBT); 82% of treatments were brief therapy (up to 8 sessions) and 12% mid/long-term (9 to 32 sessions). Each session lasted 45 min. The type of treatment was decided according to general guidelines, 12 FA literature data 13 and clinical experience.
Data on patients' perception of the effectiveness of the intervention (Table 3) showed that all patients reported improvement (60% a bit better; 40% much better) and felt the intervention was helpful (50% quite a lot; 50% a great deal).

| DISCUSSION
This is the first study, to our knowledge, aimed to investigate psychological needs and support among patients and their families undergoing food immunotherapy, assessing patients' main characteristics, reasons for seeking psychological support, OIT phase and related psychological difficulties, type and timing of treatments and patients' perception of the effectiveness of the intervention.
More than half of psychological interventions in our sample were requested at the initial phase of OIT. During the induction phase, patients undergo an initial OFC and are repeatedly exposed to increasing amounts of food allergen until the maximal tolerated dose of allergen is established. In this phase patients actually get a detailed picture of the facets and dangers related to the severity of their FA and, therefore there is higher potential of increased fear and anxiety. 7 QoL in patients initiating OIT is significantly affected, not only by the severity of previous reactions, but also by their tolerated starting doses. This may reflect appropriate anxiety in the face of a more severe FA but might also affect patient motivation and coping ability during treatment. 7 Psychological support can reduce excessive anxiety and distress and enhance the patient's personal and family resources.  16,17 The demands of the adolescents' illness and therapy require them to comply with both parental and medical instructions.
This doubling of authority, at a time where independence is typically sought, can lead adolescents to wilfully defy established rules 16 with possible risk of dropout for OIT. Adolescents were found to be more receptive to a collaborative, empathic, patient autonomy granting and motivational approach. 16 On the other side, adolescents who reported greater responsibility in their FA self-management, also described feeling more anxious. 18 Excessively anxious teenagers need to be supported especially in the initial phase of OIT. A number of treatments were addressed to mothers: this is in line with previous studies reporting that mothers are more involved in FA management and show higher scores than fathers for anxiety and distress. [19][20][21] Finally, some interventions were addressed to children and to adults mainly for emotional problems at the initial phase.
Based on findings, 70% of patients asked psychological care mostly for emotional problems that included dysfunctional anxiety, mood disorders, increased distress and excessive worry and/or fear related to OIT. These emotional difficulties can interfere with the compliance but also with the progress of the therapy. Anxiety expressions can mimic the symptoms of an allergic reaction (e.g., difficulty in breathing, abdominal pain) while a distress status can exacerbate some allergic manifestations (e.g., dermatitis and asthma). 6 great concern and distress that is counterproductive to continue the treatment.
Finally, 10% of treatments were requested because of eating difficulties such as excessive diffidence and fear or even disgust toward food that interfered with the assumption of OIT foods. Oral immunotherapy requires patients to eat the food that they have long been taught to carefully avoid or which in the past has been the source of even severe reactions. Furthermore, children with FA have shown low interest in tasting new foods 26 and a common oral aversion to the allergenic food. 3 In these cases, in addition to emotional support and CBT, the use of relaxation and GAI was found to be useful. These techniques aimed to decrease the levels of hyperactivation and distress, to draw out emotional fantasies and to facilitate the cathartic release of emotions that are present but painful or disturbing for the patient, leading to desirable changes in both affect and attitudes toward life situations. 11 Moreover, 50% of patients reported a recent anaphylaxis.
Anaphylaxis constitutes the most frightening allergic reaction, placing patients at high risk of death. This can motivate patients to start OIT, often with the aim of achieving a buffer against an unintentional reaction. 27,28 However, a recent study proved that a meaningful proportion of children and parents showed acute distress symptoms after food-induced anaphylaxis 29 : this can interfere with the OIT pathway and, on the other side, the burden of therapy can worsen the distress condition. The physical, cognitive, and behavioural aspects of distress and anxiety that may be associated with anaphylactic risk must be addressed to ensure optimal psychological as well as medical outcomes. 6,29 With regard to type and timing of treatments, the majority of patients needed psychological support including talk therapy, brief CBT, relaxation treatment and GAI, in order to normalise and sustain a functional level of anxiety and to facilitate more adaptive approaches (emotional, behavioural, cognitive and social) and