Sample: The target population includes adults ages 18 years old and older with a diagnosis of GAD based on The American Psychiatric Association’s (2013) The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Additional inclusion criteria include the ability to speak and understand spoken and written English. Those with comorbid mental disorders are eligible for participation in order to allow for generalizability as many patients with GAD have comorbid diagnoses (Edmund & Sheppard, 2018). Patients taking anti-anxiety medications in addition to SSRIs, such as benzodiazepines, also remain eligible as it would be illogical, unethical, and unsafe to expect patients taking these medication to cease their administration and change to only SSRI therapy immediately. Participants will be recruited during their appointments, either initial or follow up, at an NP-owned family practice clinic in Northwest Indiana. Exclusion criteria includes individuals with current suicidal ideation, psychosis, cognitive impairment, and/or an inability to speak or understand English. Pregnant women and individuals younger than the age of 18 are also excluded.
Methods: High quality and high level evidence strongly supports the combination of self-administered CBT and SSRIs for anxiety symptom reduction. Approximately 81% of patients with GAD have responded well to combination CBT and pharmacotherapy compared with a 60% response rate for CBT alone and 55% response rate for pharmacotherapy alone (McBride, 2015). CBT is a form of psychotherapy that aims to modify thinking in order to combat dysfunctional thinking, encourage positive thoughts, and develop coping strategies for anxiety (Bystritsky et al., 2013; McBride, 2015). Antidepressant medications in the form of SSRIs are considered first-line therapy for GAD (Edmund & Sheppard, 2018). A best practice protocol was developed in accordance with the literature. In fulfillment of the protocol, a CBT workbook for anxiety will be administered in combination with the prescribing of an SSRI medication for each participant. Participants will complete the workbooks independently and take the medication as directed over an implementation period of 12 weeks. Stakeholders, including NPs, office managers, patients, and the community, are supportive of this endeavor. The Neuman Systems Model and Stetler Model were selected to aide in project implementation based on their applicability to core components.
Results: Multiple outcomes were selected for measurement in accordance with the literature, including one primary outcome and four secondary outcomes. The primary outcome to be measured is anxiety symptoms via the GAD-7 Scale, a valid and reliable tool for measuring anxiety symptom severity via patient self-report (Beard & Bjorgvinsson, 2014; Spitzer, Kroenke, Williams, & Lowe, 2006). A secondary outcome of depression symptoms will be measured via the Patient Health Questionnaire (PHQ-9), a self-report tool for determining depressive symptom severity also with high validity and reliability (Kroenke, Spitzer, & Williams, 2001). Change in GAD status is to be measured via the Clinical Global Impressions-Improvement (CGI-I) Scale, which measures improvement or worsening of the disorder (Busner & Targum, 2007). Patient acceptability via the attrition rate, or the percentage of participants lost to follow up, will be measured. Patient satisfaction will be measured via the Patient Satisfaction Questionnaire (PSQ), a tool developed by the project manager to assess participant’s level of satisfaction with use of the CBT workbooks regarding the concepts of convenience, ease of use, efficacy, overall satisfaction, worthiness, and engagement (McClanahan, 2018). The GAD-7 Scale and PHQ-9 will be measured at baseline, 4 weeks after the start of the intervention, 8 weeks after the start of the intervention, and 12 weeks after the start of the intervention. The CGI-I Scale will be measured 4 weeks, 8 weeks, and 12 weeks post-intervention. Patient acceptability and patient satisfaction will be measured upon project completion at 12 weeks post-intervention. Pre-intervention and post-intervention data will be analyzed via a paired t-test.
Nursing Implications: Results will provide worthwhile information to benefit nursing practice regarding the effectiveness of combined CBT and SSRIs for GAD treatment. Such intervention is anticipated to reduce anxiety symptoms among affected individuals. There is a call among the literature for providers to be more aware of the prevalence and severity of GAD, express greater sensitivity in the treatment of mental health, be more diligent and knowledgeable in assessing and diagnosing those affected, make treatment of GAD a priority, and provide better and earlier management of GAD among children, adolescents, and adults (McBride, 2015). This evidence-based practice project can aide in such advancements within the nursing profession regarding GAD.
Conclusions: Should the intervention protocol demonstrate a reduction in anxiety symptoms, providers will be encouraged to incorporate this protocol into practice to provide safe, accessible, effective treatment for GAD and improve anxiety/depression symptoms, GAD status, and quality of life. There is overwhelming support within the literature that combination therapy via CBT and SSRIs is best practice and yields the best outcomes. Evidence also greatly supports a need for this practice change, which incorporates the necessary components of best practice and aims to improve shortcomings in current clinical practice.
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