Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial
- Conditions
- Generalized Anxiety DisorderGAD
- Interventions
- 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.
- Registration Number
- NCT04364958
- Lead Sponsor
- Servicio Canario de Salud
- Brief Summary
The main goal of this study is assess the effectiveness of a PtDA for patients with GAD.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group A web based-Patient Decision Aid (PtDA) (shown on the computer) 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. Control group A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care. 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.
- Primary Outcome Measures
Name Time Method Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) Change from Baseline at 3 months after intervention 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.
- Secondary Outcome Measures
Name Time Method Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) Change immediately after intervention 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.
Knowledge about the disorder and treatment alternatives Change from Baseline at 3 months after intervention A10-item scale will be include to assess patients' knowledge of the disorder and
Treatment preference Change immediately after intervention Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure).
Actual treatment choice Change from Baseline at 3 months after intervention Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure).
Decision quality Change from Baseline at 3 months after intervention Assessed by a binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance between values and intention.
Concordance between preference and choice Change from Baseline at 3 months after intervention Assessed by a binary variable (concordant/non-concordant) derived from the congruence between preference and choice.
GAD symptoms Change from Baseline at 3 months after intervention Assessed with the Generalized Anxiety Disorder questionnaire (GAD-7)
Trial Locations
- Locations (1)
Servicio de Evaluación del Servicio Canario de la Salud
🇪🇸Santa Cruz de Tenerife, Spain