reviewed by
Leen Hashem, Clinical Analyst at Sidekick Health
The Study
Effect of pharmaceutical care program on depression among women with epilepsy: A randomized controlled trial (IPHIWWE study) (Losada-Camacho M. Epilepsy Behav. 2022 Apr)
Epilepsy: The Story
In a randomized controlled trial conducted in Bogota, Colombia, researchers investigated the effects of a pharmaceutical care program on depression in women with epilepsy, compared to usual care.
Why it’s Important
Depression is the most common comorbidity in patients with epilepsy. It affects 11-62% of patients, but is twice as prevalent in women than in men. Depression in epilepsy is associated with reduced adherence to medication, poorer seizure control and sleep quality, higher rates of adverse events resulting from anti-seizure drugs (ASDs), increased risk of suicide, and higher healthcare costs. It is also strongly associated with lower quality of life in patients, regardless of seizure frequency.
The exact etiology of depression in epilepsy is still being explored, but studies have shown that psychosocial, neurobiological, and disease-related factors play a role in its development. Psychosocial factors include complications of epilepsy such as employment issues, financial stresses, social isolation, and stigma. Neurological factors include the shared structural/functional abnormalities in different brain regions in patients with epilepsy and depression. Finally, disease-related factors include frequency and control of seizures and side effects of antiepileptic drugs.
Controlling seizures, adhering to ASDs, limiting ASD side effects and adjusting to life with epilepsy can all improve symptoms of depression in patients with epilepsy. Therefore, creating a pharmaceutical care program that addresses these factors may help reduce the impact of depression on patients.
The Details
In this study, WWE were randomized to either the intervention (receiving a pharmaceutical care program) or the control group (receiving usual care in the specialist clinic).
All participants were assessed at baseline and six months. Symptoms of depression were evaluated using the Center for Epidemiologic Studies Depression (CES-D) scale, and health-related quality of life was assessed using the Quality Of Life In Epilepsy-31 inventory (QOLIE-31).
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Participants received the pharmaceutical care program for six months. A trained pharmacist delivered the program, which had five components:
- Medication review: at baseline, each patient’s medications were reviewed according to Dáder’s method, and all drug-related problems were identified. Then, individualized action plans were designed based on patient needs and concerns. The plan and patients’ medication profiles were reviewed and modified monthly or bi-monthly.
- Health education: once a month, participants were educated on different topics, including epilepsy in women, quality of life and epilepsy, pharmacological and non-pharmacological treatment in epilepsy, contraception, fertility, pregnancy, and childbirth, sleep hygiene, breastfeeding and homecare, menopause and bone health, and how to improve memory. The study’s principal investigator delivered these education sessions, which were interactive, and participants could ask questions.
- Support with treatment adherence: participants were educated on the effect of ASDs in controlling their disease and the importance of taking medication regularly. Also, those who took multiple medications received a medication record. In addition, pill boxes and reminders (e.g., an alarm clock) were given to participants to optimize adherence.
- Seizure journal: at baseline, participants were given a seizure journal and taught to record their seizures and possible triggers. The information from the journal was then used for the management of their disease.
- ASD monitoring: participants who met the inclusion criteria of the International League Against Epilepsy were instructed on the proper conditions for blood sampling.
Participants in the control group continued with the usual care they received at the specialist care clinic. At the end of the first interview, where their medications were similarly reviewed according to Dáder’s method, control group participants also received a seizure journal to complete during the study. Additionally, they were given a brochure explaining “what to do in a seizure.”
The Outcomes
182 women with epilepsy were enrolled in the study, and 79% (n=144) completed the study. Results showed:
- Percentage of participants who showed signs of depression decreased in the intervention group—from 48.59% at baseline to 30.43% at the end of the study, which was statistically significant (P=0.02). In comparison, the percentage of participants who showed signs of depression remained the same in the control group—47.30% at both baseline and end of the study (P=0.86). This finding demonstrated the positive effects of the intervention on depression among the participants.
- Change in the CES-D score (before-after) between the intervention and control group was statistically significant (P=0.02), indicating improving depression in the intervention group.
- Depression was inversely correlated with quality of life in both groups, showing that a reduction in depression (CES-D score) was associated with improved quality of life (QOLIE-31 score).
The Key Takeaway
Implementation of a comprehensive pharmaceutical care program delivered by a trained pharmacist, which includes medication reviews and monitoring, epilepsy-related health education, and support with treatment adherence, likely improves depression and quality of life in women with epilepsy.
Sidekick Health’s digital therapeutic solution combines patient education, evidence-based interventions, AI-driven personalization, and advanced remote monitoring, which unite to provide an integrated self-management platform with the potential to truly transform epilepsy care. The Sidekick platform can also leverage gamification to optimize patient adherence to evidence-based therapies, as well as mitigate the effects of comorbidities and anxiety and depression through cognitive behavioral therapy and mind-body practices.
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