Anxiety disorders are common mental disorders characterized by emotional and stress reactions to a threat or anticipation of future concern (1), leading to a significant effect on a person’s physical and social functioning. Previous research revealed that individuals with anxiety disorders are associated with significant impairment to personal life (2) and quality of life (3), suicidal ideation and suicide attempts (4), and high care costs (5). Therefore, continued improvement in the care of people with anxiety disorders is important.

Benzodiazepine (BZD) anxiolytics are one of the treatment choices that are frequently used worldwide for the acute phase of anxiety disorders. However, the long-term BZD anxiolytic use is not recommended because of its disadvantages, including dependence (6), decline in cognitive functions (7), hip fractures associated with falls (8, 9), and impaired driving ability (10). Consequently, most anxiety disorder guidelines recommend that BZD anxiolytics should be used for only a short period (11–15). Moreover, some guidelines do not recommend the use of BZD anxiolytics, even for short-term periods, except in critical situations (16, 17).

Despite the evidence-based recommendations described above, BZD anxiolytics are commonly used worldwide for anxiety disorders (18, 19). Therefore, the safe discontinuation or tapering of BZD anxiolytics for anxiety disorders is essential. Thus, the establishment of treatment strategy against long-term BZD use for anxiety disorders may be warranted in clinical settings.

To address this issue, the evidence that psychological therapy is effective in reducing symptoms for anxiety disorders should be considered (20). Particularly, cognitive behavioral therapy (CBT) is an effective psychological intervention for anxiety disorders (21, 22). Several current guidelines recommend CBT as a first-line therapy because of its effectiveness in improving anxiety symptoms and comparatively fewer risks than BZD anxiolytics (11, 12, 17). Several trials assessing strategies for BZD discontinuation, such as gradual tapering or adding CBT, have reported the effectiveness of adding CBT in the short term (23). On the other hand, CBT has certain disadvantages, such as the lack of a fast-acting effect, longer consultation time, and high cost (24). Therefore, individuals with anxiety disorders deliberating on further non-medication treatment might face the advantages and disadvantages of CBT.

Approaches of treatment decision-making have shifted from the so-called paternalistic approach, where doctors take initiative in the decision-making, to patient-centered communication. In this type of approach, strategies such as “shared decision making” (SDM) have been emphasized, which focus on a patient’s value-based discussion that involves a two-way communication between the patient and their clinician about the positive and negative aspects of each treatment option (25, 26).

In relation to the SDM process, decision aids (DAs) have recently gained attention as patient-centered communication tools that promote two-way conversation between patients and healthcare providers during specific medical or mental conditions that require further treatment planning (27). DAs are intended to support individuals participating in the decision-making process by aiding them to make well-informed, preference-based choices when choosing their treatment options (27). DAs provide related information regarding the available options and aid people to solidify their own preferences, which are associated with different characteristics of each option (27). DAs can promote a patient’s involvement and increase concordance between their choices, preferences, and values during the decision-making process (28).

Various DAs, most of which were for decision-making during treatment initiation, have been developed in many areas including the somatic and psychiatric fields (28). Moreover, we developed several DAs for decision-making about whether the treatment should be continued or discontinued such as DA for depression remission (29) and DA for insomnia remission (30). Ramos-García et al. developed a Spanish version of DA for patients with generalized anxiety disorder (31), based on their needs that patients with GAD preferred an active and collaborative role in decision-making (32). However, to our best knowledge, there is no Japanese version of a DA for patients with anxiety disorders who are receiving BZD anxiolytics and considering further pharmacology treatment.

The aim of this study was to develop a Japanese version of DA for patients with anxiety disorders who are considering whether to discontinue BZD anxiolytics as well as whether to taper them with CBT or without CBT, if discontinuing BZD. The stakeholder’s acceptability of the DA were also examined. We have translated the DA into English so that many more people can utilize it.

This is the first study to develop and assess the acceptability of a Japanese/English version of the DA for individuals with anxiety disorders for considering whether to continue BZD anxiolytics and whether CBT for anxiety should be added, if BZD is being discontinued.

The acceptability testing results suggested that the DA was well acceptable and favored by both patients and clinicians. This indicates that the DA was confirmed by stakeholders who were expected to use our DA. The strong point of the DA is that the committee systematically developed this tool using evidence-based criteria, in which both patients and clinicians, who were not involved in the development process, confirmed the DA. This implies that DA can be used in clinical settings. Ramos-García et al. also reported that their Spanish DA for patients with generalized anxiety disorder was easy to use, virtually appealing, and accepted by patients and clinical experts (31). These studies supported the suitability of DAs for anxiety-related disorders. Given that most people are highly motivated in contributing to the decision-making about their own treatment (32), these novel DAs could address the needs of patients with anxiety disorders.

The discontinuation of BZD anxiolytics has several advantages and disadvantages. The advantages include avoidance of adverse events, such as falls, drowsiness, and cognitive decline, whereas the disadvantages include worsening of anxiety and possible withdrawal symptoms. Thus, even if the patients desire to discontinue their medication, they may face conflicts between the advantages and disadvantages. Our DA might possibly reduce this conflict, since this tool successfully provides the evidenced-based characteristics of each option and asks the patients to clarify their own preferences. Using our DA with healthcare providers might also help patients to deliberate on further treatment courses with less conflict.

Several studies have been conducted to develop and assess psychosocial interventions for dealing with the risks of BZD use thus far (23). Heather et al. (45) reported that individuals with insomnia who received a letter warning about the harms of long-term use of BZD hypnotics showed larger reductions in BZD consumption than those who did not receive such a letter (23, 43). Thus, the presentation of not only the advantages but also the disadvantages of anxiolytic use to patients might lead to successful medication reduction. Our DA included both advantages and disadvantages of anxiolytics in a well-balanced manner. Moreover, our DA succeeded in supplying daily activities and relaxation techniques to reduce anxiety, which individuals with anxiety disorder could adopt in their everyday lives. In these regards, our DA contributes to the current literature, which suggests useful psychosocial interventions focusing on the prevention of the adverse aspects of long-term anxiolytic use. Furthermore, the uniqueness of our DA is that we have created a framework that allows patients to discuss and decide their options together with their clinicians, rather than unilaterally providing them with related information.

This study has some limitations. First, although our DA fulfilled most IPDAS quality criteria (35), some items should be covered in the future to improve the quality. Those items include field-testing and providing evidence of the intervention. To address this issue, the steering committee plans to conduct beta field-testing during the decision-making process of whether to discontinue BZD anxiolytics in a clinical setting. Second, there may be differences in the level of acceptance and appreciation among the patients who were shown their diagnosed disorder through the DA. Therefore, we plan to examine the differences between the diagnoses in beta field-testing. Third, patients with anxiety disorders often take antidepressant and BZD including some participants in this study. Therefore, there may be differences in the difficulties of discontinuing BZD if an antidepressant was also taken. We then plan to examine the differences between those on antidepressants and those who were not on antidepressants, in the beta field test. Forth, CBT for anxiety disorders include different elements and unique skills are required for each anxiety disorder. Our DA provided only non-specific general information of CBT for anxiety disorders, which is a limitation of this study. Additionally, the intervention effects of this DA need to be verified in a clinical setting.

This study described the development process and acceptability of a DA for the tapering BZD anxiolytics for anxiety disorders. The developed DA was acceptable to all stakeholders. The results could help in the treatment decisions of both individuals with anxiety disorder and their clinicians who are deliberating on the discontinuation of anxiolytic therapy.

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

The studies involving human participants were reviewed and approved by The Ethics Board of Kyorin University. The patients/participants provided their written informed consent to participate in this study.

YA: study design, drafting and revising the DA prototype, data analysis and interpretation, revising the DA, and drafting the manuscript. KI, MTak, and TO: study design, revising the DA prototype, data collection, data analysis and interpretation, revising the DA, drafting, and editing the manuscript. HY, TM, TK, and MTan: study design, revising the DA prototype, data interpretation, revising the DA, and editing the manuscript. YT and KM: study design, revising the DA prototype, data collection and interpretation, revising the DA, editing the manuscript, and funding acquisition. All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data, took part in drafting the article or revising it critically for important intellectual content, agreed to submit to the current journal, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

This study was supported by research grants from the Ministry of Health, Labor and Welfare of Japan (19GC1012 and 21GC1016).

YA received speaker’s honoraria from Sumitomo Pharma, Meiji Seika Pharma, Viatris Pharmaceuticals Japan. YT received a lecture sponsorship from Takeda Pharmaceutical, Sumitomo Pharma, Otsuka Pharmaceutical, Meiji Seika Pharma, Kyowa Pharmaceutical, Eisai, MSD, and Yoshitomi and re-search funding from Otsuka Pharmaceutical, Meiji Seika Pharma, MSD, and Eisai. KI has received personal fees/grant support from Eisai, Eli Lilly, Janssen, Meiji Seika Pharma, Mitsubishi Tanabe Pharma, Mochida, MSD, Novartis, Otsuka, Shionogi, Sumitomo Pharma, and Yoshitomiyakuhin in the last three years. HY received lecture fees from Takeda Pharmaceutical, Lundbeck Japan, Sumitomo Pharma, Otsuka Pharmaceutical, Meiji Seika Pharma, Janssen Pharma, Kyowa Pharmaceutical, Eisai, MSD, Yoshitomiyakuhin, Mochida Pharmaceutical and Viatris in the last three years. TM declares no interest of conflict. TK has received speaker’s honoraria from Takeda Pharmaceutical, Sumitomo Pharma, Viatris Pharmaceuticals Japan, MSD, Eisai, Ltd., and Yoshitomi Pharmaceutical. MTak has received speaker’s honoraria from Takeda Pharmaceutical, Otsuka Pharmaceutical, Daiichi Sankyo Company, Sumitomo Pharma, Meiji Seika Pharma, Viatris Pharmaceuticals Japan, MSD, Eisai, Ltd., and Yoshitomi Pharmaceutical, and research grants from Otsuka Pharmaceutical, Eisai, Shionogi and the Japanese Ministry of Health, Labour and Welfare (R3-21GC1016) outside the submitted work. MTan declares no interest of conflict. KM received speaker’s honoraria from EISAI Co., Ltd., Nobelpharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., MSD Inc. and research grants from Eisai Co., Ltd., Sumitomo Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., AMED (JP21dk0307103KM), the Japanese Ministry of Health, Labour and Welfare (19GC1012, 21GC0801). TO has received speaker’s honoraria from IQVIA, Takeda Pharmaceutical, Otsuka Pharmaceutical, Daiichi Sankyo Company, Sumitomo Pharma, Meiji Seika Pharma, Viatris Pharmaceuticals Japan, MSD, Eisai, Ltd., Kyowa Pharma, Lundbeck Japan, Lily, and Yoshitomi Pharmaceutical.

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