Psychoeducation on Medication for People with Anorexia Nervosa: A Quality Improvement Project

1.1 Anorexia nervosa

Anorexia nervosa (AN) is a serious psychiatric disorder that can be associated with poor outcomes. The diagnostic criteria of the condition are characterized by the drive to achieve and maintain a low body mass index (BMI), an intense fear of weight gain and body image disturbance [1]. AN can take a chronic course and has a high mortality rate. Therefore, the standard mortality rate is ∼5.9 [2] which is the highest mortality rate within psychiatric conditions. The high risk of dying is not only caused by the acute physical risks associated with AN but also due to the increased risk of suicide which is prevalent within this patient population [3, 4]. The lifetime risk for the development of AN is up to 4% in females and 0.3% in males with the peak incidence occurring within teenage years on average, aged 15.5 years old [5, 6, 7]. The course of AN can often be chronic with only 46% of patients managing to fully recover from the disorder and 20% of sufferers remaining chronically ill [3, 4]. The chronic course of the disorder compounds the significant impairment of the individual’s physical health and psychosocial functionality [8]. The high mortality rate and significant debility caused by AN propagates the urgent need to optimize and explore psychopharmacological treatment options to improve both recovery rates and quality of life for current sufferers.

1.2 Psychopharmacological treatment for anorexia nervosa

Whilst psychopharmacological treatment options for other serious psychiatric conditions expanded exponentially through the 1950’s with the development of new antipsychotics and antidepressants, the application of these medications within patients meeting the diagnostic criteria for AN was not successful [9]. At present, there is no medication approved to treat AN [3, 10] despite the correlation and overlap of symptoms with many other psychiatric diagnoses, namely, low mood, anxiety, and disrupted sleep [11].

The intense fear of weight gain, characteristic of the disorder, can often serve as a barrier to patients participating in trials of medication, where weight gain is a potential or known side effect. This barrier is both problematic for randomized controlled trials [RCTs] recruitment and for ongoing management by eating disorder teams [12]. Not only do some medications confront the fear of weight gain but other side effects such as metabolic changes, cardiac issues, sedation, and bone marrow suppression also may cause reluctance to commence such medication, without effective counseling of the risks presented. Even though medication has become an accepted means of self-management in many Western societies, patients with AN often see the refusal of recommended medication as a personally meaningful practice to resist their treatment [13].

The ambivalence of patients to engage in psychopharmacological treatment contributes to the lack of RCTs currently available in AN. The few published RCTs often have a small size [14], and the RCTs which have been published show only modest remission rates at the end of treatment varying between 13 and 43% [15]. The lack of RCTs with substantial sample sizes and with significant evidence of the benefits of psychotropic medications poses significant challenges to the medical management of this patient group.

Whilst there is no approved psychopharmacological treatment of AN, many medications are used by clinicians off-label to help improve specific symptoms patients may struggle with.

1.3 The patient’s perspective

Self-starvation is a mechanism that serves people with AN to cope with difficulties such as acute stress, anxiety, and low mood. Within patients with acute AN, studies have demonstrated a positive correlation between low body weight and fewer emotional regulation difficulties, establishing that the maladaptive mechanism of caloric restriction is of benefit to the patient in managing aversive emotions [16]. Aiming at weight restoration could therefore be interpreted as a threat to the individual, forcing them to re-experience the underlying mood difficulties, whereas maintaining a low BMI mitigates experiencing their low mood; this mechanism impacts their motivation for recovery [17]. Thus, if the underlying psychological problem of low mood or anxiety could be treated, there would be a chance to mitigate the overall resistance to weight restoration.

Medication compliance and interest in commencing medication from a patient’s perspective would be more acceptable if focused on emotional dysregulation as opposed to weight gain, due to the fears this elicits. Thus, psychological improvement of patients with AN should be pursued and interpreted as a separate important outcome measure independent of weight restoration [18]. Psychological improvement can be a tool to aid future recovery and reduce functional impairment.

With effective medication counseling and empowering patients’ autonomy over their condition and treatment, medication compliance and psychological improvement could be seen.

1.4 Aim of the study

As explained above, no psychopharmacological medication has been approved for use in people with AN. Nonetheless, people with AN are prescribed various medications for off-label use. Off-label use, however, requires a shared decision based on sufficient information that should be given to the patients.

This study was designed to provide psychoeducation to people with AN on the use of medication to help with the AN and associated physical and mental health consequences. We hypothesized that patients would feel better informed about both physical health medication and psychotropic medications that may be used as part of the treatment of their eating disorder.

The intervention was added to treatment as usual (TAU). In our eating disorders service, TAU includes psychological therapy (Cognitive Remediation Therapy (CRT), Cognitive Remediation and Emotional Skills Training (CREST), Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA), Cognitive Behavioral Therapy (CBT), Motivational Enhancement Therapy (MET), dietary advice, physical health monitoring, nursing and occupational therapy. A questionnaire was created to determine current knowledge of both physical health medications and psychopharmacological medications and how well-informed patients with AN felt about making decisions regarding medication they have been or may currently be prescribed. Following the collation of these data, two workshops were conducted to provide education on both physical health medications and psychopharmacological medications in relation to eating disorders. A leaflet with supplementary and supporting information was given to patients as a learning aid including the pharmacokinetics, pharmacodynamics of commonly prescribed physical health and psychotropic medications. The efficacy of these workshops was later assessed, and this information was collated to determine how useful these sessions and the leaflet were to the participants. Within this publication, we present the statistical analysis of the survey.

2.1 Patient sample

The psychoeducation was offered to all patients on the inpatient eating disorder unit and eating disorder day services within the South London and Maudsley NHS Foundation Trust. Thus, all the patients who were admitted to inpatients or day services were eligible to participate in the study. Our unit is specialized in the treatment of people with AN. No patients were excluded based on physical health conditions. No payments were made to participants included in the study.

A total of 11 patients with AN, according to the ICD-10 criteria, 10 females and one gender-fluid person, agreed to participate in the quality improvement (QI) project. Patients were between 19 and 37 years of age. The mean age (±standard deviation) was 27 (±6) years. Nine patients were treated in the South London and Maudsley NHS Foundation Trust eating disorders day service and two on the inpatient unit. The duration of current treatment in the named service ranged between 1 month and 9 months; the mean duration of treatment was 4.4 (±3.0) months. The duration of their AN was between 3 years and 28 years with a mean of 12 (±7.3) years.

The main psychiatric comorbidities were depressive disorder (46%), anxiety disorders (36%) and obsessive-compulsive disorder (18%). Some patients currently took or had regularly taken the antidepressants fluoxetine (18%), sertraline (36%), citalopram (9%), mirtazapine (9%) or venlafaxine (9%), the atypical antipsychotics olanzapine (36%) or quetiapine (18%), the anxiolytics diazepam (9%) or promethazine (18%), or melatonin as sleep aid (9%).

2.2 Questionnaires

The QI project team which consisted of patients and clinicians from the eating disorders inpatient ward and day service unit within the South London and Maudsley NHS Foundation Trust (SLaM) developed a questionnaire to measure the effectiveness of the psychoeducational intervention.

The questionnaire had four main sections. The first section provided personal information about the patient and their experience with prescribed medication, current or historical, relating to their eating disorder and general mental health. The second and third sections use a series of 4-point Likert scale questions, ranging from 0 to 4 (0 = strongly disagree, 2 = neutral, and 4 = strongly agree). The second and third sections focused on how well-informed patients feel about making decisions relating to medication before and after the workshop and leaflet being distributed, respectively. These questions had four domains: Medication for eating disorders, medication for other mental health disorders, pro-re-nata (PRN) medication, which means medication as required, and medications for physical health consequences.

The fourth section evaluated how helpful the participants found both the workshop and leaflet. The questionnaires were completed by 11 patients with AN between June and July 2023. The patient questionnaire used is depicted in the appendix of this article.

2.3 Workshops and leaflet

There were two separate workshops. One focused on physical health medications patients may have come across in the treatment of their eating disorder, and the other focused on psychopharmacological medication. A leaflet was also co-designed by patients and clinicians to provide concise information on pharmacokinetics and pharmacodynamics, physical health medication and psychopharmacological medication. Drawings, created by patients, were incorporated into the materials. The leaflet can be provided upon request to the corresponding author.

2.4 Data evaluation and statistics

The data collected were entered into an excel spreadsheet and fed into IBM SPSS Statistics Version 29. The differences between baseline and after the interventions were calculated using t-tests.

2.5 Ethical approval

The study was approved as a QI project by the QI committee of the South London and Maudsley NHS Foundation Trust in May 2023.

3.1 Facilitation and acceptance

All (100%) QI project participants reported that they attended both workshops, the workshop on psychopharmacological medication and the workshop on physical health medication. All (100%) answered that they had been given written information on medications for physical health related to eating disorders. However, only 91% answered that they had been given the information on medications for eating disorders and on other mental health conditions. About 64% confirmed they had received written information on PRN medications for mental health, and 73% agreed they had received leaflet information on medications for physical health related to eating disorders.

3.2 Quantitative results

QI project participants rated their opinion regarding how well-informed they felt about making decisions on medication for eating disorders using a questionnaire that contained 47 questions. Questions 11 to 22 measured the feeling about being informed before the intervention on a 4-point Likert scale with values between 0 and 4, and questions 23 to 34 were corresponding questions which were asked after the intervention. Table 1 depicts the mean scores ± standard deviations and the two-sided p-value of a t-test.

The patients who took part in the project felt significantly better informed about medications to make decisions for their own treatment. This applied to all questions asked in the four domains: Medication for eating disorders, medication for other mental health disorders, PRN medication and medications for physical health consequences.

3.3 Qualitative results

In the free text, patients wrote that they want to be informed about how and where to bring up being prescribed the medication, when the medication should be reviewed and how to come off the medication. They also wanted to learn more about the statistics of effectiveness in patients. One patient wished to have more information on PRN medication for mental health during the workshops. While thanking the study team and the facilitators, one patient wrote “Thank you! It’s not something that’s relevant right now but was useful to think about past medication and hear about future research”.

4.1 Summary and interpretation of the results

In the reported QI project, we facilitated psychoeducational activity for people with AN in intensive care settings (inpatient and day service) to provide information on the use of medication to help with eating disorders. The psychoeducation consisted of three elements:

• A co-designed leaflet for people with eating disorders with information about psychopharmacological and physical health medication with a focus on eating disorders, their comorbidities and health consequences.

• An interactive seminar on psychopharmacological medications.

• An interactive seminar on medication for physical health medications.

The 11 patients who took part in the project felt significantly better informed about medications to make decisions for their own treatment. Thus, we achieved the aim of this intervention which therefore seems feasible to be tested in a larger group of patients.

However, areas that patients felt should have been covered better in the workshops and on the leaflets were as follows:

• How to approach clinicians to talk about medications and discuss prescriptions?

• When medications should be reviewed?

• How to come off medications?

• What makes a medication deemed effective in terms of the underlying statistics?

• PRN medication for mental health.

After the facilitation of the two workshops and handing out the leaflet on medication to help with eating disorders, patients felt significantly better informed about medications for eating disorders, psychopharmacological medication in general, PRN medication and medication for physical health conditions. They felt particularly better informed to make decisions about medication. This was the primary goal of our intervention. To make the best possible decision, a patient should be well informed about the realistic benefits and risks about medication to make the decision together with the clinician based on their own preferences and values, because this approach has been shown to be associated with higher adherence to and satisfaction with the treatment [19, 20, 21, 22].

So far, no medication has been approved for the treatment of AN. However, the severity of the ED often requires supportive psychopharmacological treatment. The best possible recommendation for AN is olanzapine as there is strong evidence to suggest that it is an effective intervention for weight recovery. Despite this, effects on psychopathology are not clear. Weight gain was the primary outcome of most published studies. Therefore, olanzapine has not yet been authorized for use in eating disorders. Other medications that have been tested for AN include antiepileptics and mood stabilizers (e.g., lithium) and appetite stimulants (e.g., dronabinol), but the evidence for these medications is limited [23].

With the off-label use of these medications, a shared decision should be reached between patients and healthcare professionals about whether the medication is to be used to support treatment of their eating disorder. Patients require sufficient information about such medications before they can make an informed decision about whether they want to take the medication or not [24]. This QI project has demonstrated that, with psychoeducational activity, patients felt better informed to make decisions about medication.

There is a high percentage of co-morbid anxiety disorders within our sample which from our experience is representative of the wider eating disorder population. We hypothesize that co-morbid anxiety symptoms (presenting in different forms) often perpetuate inability to weight restore due to food restriction being a pathological safety behavior that reduces anxiety in general. Anxiolytic medications that reduce levels of felt anxiety but do not eradicate it could help patients to expose themselves to food intake and learn that food intake and weight restoration are not real threats to them (as in exposure therapy). Put in another way, anxiolytic medication could help food feel less scary, so one is willing to expose oneself to it and learn that you do not need to be scared.

4.2 Limitations

The reported psychoeducational QI project had only a small sample size of 11 patients. Thus, the statistical significance must be interpreted with caution. The patients who took part in the project were potentially more enthusiastic and motivated than patients who did not take part. We did not keep a record of patients who declined to come to the seminars and their reasons for this. Even though the information leaflet was co-designed with patients with AN and approved by the multidisciplinary ED team at the South London and Maudsley NHS Foundation Trust, it was not independently peer reviewed. Another limitation is that we did not assess the eating disorder psychopathology in a standardized way before and after the intervention.

4.3 Future directions

Our psychoeducational QI project mainly conveyed information on medication, pharmacodynamics, pharmacokinetics, pharmacological mechanisms and principles, efficacy, and side effects. Monitoring aspects and terminating pharmacological treatment were not covered extensively or comprehensively as the written feedback from patients revealed. Another area for improvement is the relational aspect of psychopharmacology, for example, when and how a patient with an ED should approach their clinician. In contrast to psychotherapy, there is not much research about the relationship between the prescriber and the patient in EDs available. From a practical experience, we are aware that a medication can remind the patient of the prescriber and is therefore a relational symbol, as such, it should be a source of productive cooperation, motivation, and mutual trust.