Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial

Study Overview
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Brief Summary
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The main goal of this study is assess the effectiveness of a PtDA for patients with GAD.

Detailed Description
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Background: Patients with Generalized Anxiety Disorder (GAD) have concerns and needs about their health and the health care they receive. Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. PtDAs can improve shared decision-making (SDM) and lead to better treatment outcomes. The aim of this study is to evaluate the effectiveness of a web-based PtDA for patients with GAD in primary care. Methods and analysis: The general study design comprises two stages: i) Development of a web-based PtDA for patients with GAD, derived from an evidence-based Clinical Practice Guideline and, ii) Assessment of the effectiveness of the PtDA employing in a randomised controlled trial (RCT) design, in primary care centres of Tenerife (Spain). This RCT will be carried out with 156 patients with GAD with a score ≥8 in the GAD-7 questionnaire, comparing the PtDA to usual care (fact sheet with general information on mental health). Patients will review the PtDA accompanied by a researcher. Post-intervention survey will be administered immediately after the intervention. The primary outcome will be decisional conflict (immediately after intervention and 3 months after intervention). Secondary outcomes will include knowledge about GAD and its treatment (immediately after intervention and 3 months after intervention), treatment preference (immediately after intervention), actual treatment choice (3 months after intervention), concordance between preferred and chosen (3 months after intervention) decision quality with the decision-making process (3 months after intervention), and GAD symptoms (3 months after intervention).

Official Title
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The Effectiveness of a Web-based Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial

Conditions
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GAD, Generalized Anxiety Disorder

Intervention / Treatment
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* Other: A web based-Patient Decision Aid (PtDA) (shown on the computer)
* Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years) with a diagnosis of GAD (ICD-10 or DSM-V codes: 300.02; F41.1), with a score ≥8 in the GAD-7 questionnaire, with ability to speak and read Spanish, and who accept to participate and sign the informed consent Exclusion Criteria: Patients with a primary diagnosis other than GAD, a score <8 in the GAD-7, those with significant physical or mental disability that prevents from completion of study activities or those participating in other trials related with GAD treatment or education, will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients who agree participant and will sign the informed consent, will complete the baseline assessment. Then, those allocated to the intervention group will review the web-based PtDA (shown on the computer), with the help of a researcher if necessary, and then will fill the questionnaires assessing the outcome measures in the same web interface. | Other: A web based-Patient Decision Aid (PtDA) (shown on the computer)<br>* Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. This PtDA will include information about GAD symptoms, diagnosis, causes, and benefits and risks associated to psychological and pharmacological treatments for GAD (based on the Clinical Practice Guidelines-GAD). It will also include a values clarification exercise, in which patients will have to rate the importance attributed to the different aspects of treatments (e.g., mode of administration, benefits, risks, time to improvement, probability of relapse).<br>* Other names: Intervention;|
| Active Comparator: Control group<br>Patients allocated to the control group will receive a web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care, and they will also complete the same questionnaires. | Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.<br>* Patients in the control group will receive a fact sheet (one page) with general information on mental health as a part of usual care provided by the Canary Islands Health Service.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) | DCS includes 16 items and five subscales: feeling informed, clear values about benefits or risks, support, uncertainly and effective decision. Scores are transformed to a 0-100 scale, with higher scores indicating more conflict. | Change from Baseline at 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) | CS includes 16 items and five subscales: feeling informed, clear values about benefits or risks, support, uncertainly and effective decision. Scores are transformed to a 0-100 scale, with higher scores indicating more conflict. | Change immediately after intervention | 
| Knowledge about the disorder and treatment alternatives | A10-item scale will be include to assess patients' knowledge of the disorder and treatments based on the contents of the PtDA. | Change immediately after intervention | 
| Treatment preference | Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure). | Change immediately after intervention | 
| Knowledge about the disorder and treatment alternatives | A10-item scale will be include to assess patients' knowledge of the disorder and | Change from Baseline at 3 months after intervention | 
| Actual treatment choice | Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure). | Change from Baseline at 3 months after intervention | 
| Concordance between preference and choice | Assessed by a binary variable (concordant/non-concordant) derived from the congruence between preference and choice. | Change from Baseline at 3 months after intervention | 
| Decision quality | Assessed by a binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance between values and intention. | Change from Baseline at 3 months after intervention | 
| GAD symptoms | Assessed with the Generalized Anxiety Disorder questionnaire (GAD-7) | Change from Baseline at 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, Patient decision aids, Patient-centred care, Randomized controlled trial, Shared decision making, Web-based intervention, Primary Care