Exposure Therapy for Late-life Anxiety

Condition(s) studied

Investigational drug(s) / intervention(s)

Exposure therapy: The exposure therapy will be given by the mental health care nurses (MHN) working in primary care centres. In addition, there will be eight sessions spread over 12 weeks. The first session will be 60 minutes long and the rest will be 30 minutes long.

Usual Care: The Usual Care group will receive care based on the general practitioners guidelines for anxiety disorders in the primary care center. This will entail possible medication, e-learning or psycho-education, problem solving therapy or a referral to a mental health institution.

Study summary

The primary objective is to evaluate the (cost-)effectiveness of exposure therapy (ET) delivered by trained mental health nurses (MHNs) in terms of anxiety symptoms and quality of life for late life anxiety disorders in primary care compared to usual care (UC).

UC is not restricted, and the general practitioner (GP) is encouraged to work according to the guidelines of the Dutch College of GPs.

Participants in the ET group will receive 30-minute ET sessions delivered by a trained mental health nurse, during 8 sessions within the span of 12 weeks. Participants will fill in questionnaires before, during and after treatment, with a 1-year follow-up. The main study parameters are anxiety severity, quality of life and societal costs.

Eligibility

Primary outcome measure(s)

• Is ET performed by MHNs effective compared to UC in primary care for older adults with anxiety disorders in terms of QUALYs and symptoms of anxiety? — Pre-intervention, post-intervention (after 12 weeks of treatment), 3-month follow-up (FU), 6- month FU, 9-month FU, 12-month FU
  1. Anxiety severity will be assessed with the Geriatric Anxiety Inventory (GAI). The GAI is a self-report measure of general anxiety symptoms over the last week. Total scores range from 0-20, with higher scores indicating greater anxiety. 2. The second questionnaire used is the EuroQol 5-Dimension 5-Level version (EQ-5D-5L), which is used to measure quality of life. It has five subscales consisting of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 3L classification system defines the 243 health states by combining different levels (one from each dimension), ranging from 11111 (full health) to 33333 (worst health). The 5L classification system comprises the same five dimensions as the 3L, but each dimension has two more levels to the existing three levels. Accordingly, the 5L system defines the 3,125 health states ranging from 11111 to 55555. Both questionnaires will be used during the 12-week treatment period and during the 1-year follow-up.
• Is ET performed by MHNs cost-effective compared to UC in primary care for older adults with anxiety disorders in terms of QUALYs and symptoms of anxiety? — Pre-intervention T0, post-intervention (after 12 weeks of treatment, also knows as T9), 3-month FU, 6- month FU, 9-month FU, 12-month FU
  The aim is to relate the incremental costs of ET compared with UC to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective. 1. For the cost-effectiveness analysis Quality-Adjusted Life-Years (QUALYs) will be assessed with the EQ-5D-5L. 2. Anxiety severity will be assessed with the Geriatric Anxiety Inventory (GAI). Total scores range from 0 to 20, with higher scores indicating greater anxiety. 3. To assess societal costs, the TIC-P will be used. This questionnaire is the modified version of the Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P). Cost categories that will be included are: 1) healthcare costs; 2) lost productivity costs; 3) patient costs. Valuation will be done according to Dutch costing guidelines. Higher scores indicate higher societal costs.

Trial sites (1)

Other trials for the same condition