An interventional study of Exposure therapy and Usual Care in Anxiety Disorders and Anxiety Depression, sponsored by ProPersona. Recruiting at 1 site in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by ProPersona · Not applicable, Interventional, and Treatment
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.
Rationale: Anxiety disorders are common and have a high disease burden throughout the life span. Nonetheless, older people with anxiety disorders remain undiagnosed and thus undertreated. Ageism, changes in symptom phenomenology at older age and transportation barriers are reasons for underdiagnosis/-treatment. Moreover, when treated, older patients generally receive pharmacotherapy, while adverse effects increase with age and 75% of older persons prefer psychotherapy. The most effective psychotherapy, i.e. exposure therapy, has not yet been evaluated for older adults with anxiety in primary care.
Exposure Therapy (ET) is the most effective intervention for all anxiety disorders in adults. It has the potential to reduce the risk of chronicity, inappropriate healthcare use, inappropriate drug use, and unnecessary referral to specialist mental healthcare providers, which often include long, costly treatment trajectories. Exposure is well-suited to be delivered by mental health nurses (MHNs; or POH-GGZ (praktijkondersteuner geestelijke gezondheidszorg) in Dutch) in primary care centers (PCCs) because older people visit their general practitioner (GP) regularly, and PCCs in the Netherlands have the availability of MHNs. However, they are currently not equipped to offer exposure. Introducing MHN-led exposure is likely to be (cost-)effective as it matches patients' preferences and prevents inadequate or costly treatments.
Objective: The primary objective is to evaluate the (cost-)effectiveness of ET delivered by trained MHNs regarding 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 GP is encouraged to work according to the guidelines of the Dutch College of GPs.
Study design: A multi-center cluster-randomized controlled trial (RCT) with two parallel groups: a) ET and b) UC, in PCCs with a 1-year follow-up.
Study population: 170 patients, 65 years and older, with an anxiety disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Intervention (if applicable): During 8 sessions within the span of 12 weeks, 30-minute ET sessions are delivered by a trained mental health nurse.
Main study parameters/endpoints: Anxiety severity as assessed with the Geriatric Anxiety Inventory (GAI), societal costs with the Trimbos and iMTA(Institute for Medical Technology Assessment) questionnaire on Costs associated with Psychiatric illness (TIC-P) and quality of life using the EuroQol 5 Dimension 5 Level version (EQ-5D-5L) during the 12-week treatment period and 1-year follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Though the burden includes investment of the patient, no risks are associated with participation in the study. By offering participants ET in the PCC by the MHN, the participants will benefit immediately as we expect a positive influence on their anxiety symptoms.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 170 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
The participants will receive exposure therapy, entailing 8 sessions of 30 minutes spread over 12 weeks. The first session is 60 minutes long. The exposure therapy will be match to the needs and symptoms of the participant.
Behavioral: Exposure therapy
This group will receive the usual care given by GP's based on the Nederlands Huisartsen Genootschap (NHG) standard practice in the Netherlands for anxiety disorders.
Behavioral: Usual Care
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.
Also known as: Cognitive behavioral therapy
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.
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?
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.
Time frame: Pre-intervention, post-intervention (after 12 weeks of treatment), 3-month follow-up (FU), 6- month FU, 9-month FU, 12-month FU
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?
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.
Time frame: 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
Are there differences regarding secondary outcomes, such as disorder specific anxiety symptoms, comorbid depressive symptoms, general functioning and the use of psychoactive medications (i.e., antidepressants and benzodiazepines) between ET and UC?
1. Social Anxiety: Liebowitz Social Anxiety Scale (LSAS), total score ranging 0-144. 2. Generalized Anxiety Disorder (GAD): GAD-7 scale, total score ranging 0-21. 3) Panic Disorder: Panic Disorder Severity Scale-Self Report (PDSS-SR), total score ranging 0-28. For all three questionnaires is a higher score an indication for more severe anxiety. 4) Agoraphobia: Mobility Inventory (MI), 27 items rated from 0 (never avoids) to 4 (always avoids). Scores are averaged based on situations experienced alone or accompanied. Depressive Symptoms: Quick Inventory of Depressive Symptoms (QIDS-SR), total score ranging 0-27. Higher scores indicate greater severity. General Functioning: 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). Average scores 1 (no disability) to 5 (extreme disability). Medication use: use of benzodiazepines and antidepressants, binary yes/no.
Time frame: Pre-intervention T0, post-intervention (12-week), 3-month FU, 6- month FU, 9-month FU, 12-month FU
Do factors such as ageist biases of participants and mental health nurses, cognitive functioning, therapeutic expectations and alliance influence the effectiveness of exposure therapy in treating late-life anxiety?
* Ageist biases of participants and mental health nurses will be measured using the 12-item Shortened Expectations Regarding Aging Survey (ERA-12), consisting of 3 subscales and total score ranging 0 to 100. * Cognitive functioning will be measured with Montréal Cognitive Assessment scale (MoCA) total score ranging 0-30. * Therapeutic expectations will be measured with Credibility \& Expectancy Questionnaire with 6 items. This measure is scored on a Likert scale ranging from 1 to 9 (e.g., 1 means 'not at all', 5 'somewhat', and 9 'very much') or from 0% to 100% (in 10-point increments). Items 4 and 6, coded from 0%-100%, are converted linearly on a Likert scale from 1 to 9. * Therapeutic alliance will be measured with Working Alliance Inventory (WAI), total score is the average of 12 items, with a maximum score of 5.
Time frame: Pre-intervention T0, post intervention (after 12 weeks of treatment, also knows as T9) and at the 12 month follow-up
Do changes in threat expectancy, avoidance and safety behaviours, self-efficacy, metacognitions (i.e. beliefs about cognition) and worry partially explain the effectiveness of ET compared to UC
- Threat expectancy: As part of the treatment protocol, participants rate: Before exposure: Threat expectancy (0-100%) - likelihood of feared outcome. After exposure: Threat occurrence (0-100%) - extent of feared outcome, and Adjusted threat expectancy (0-100%) - likelihood of outcome if repeated. * Avoidance will be measured with: 1. Brief Experiential Avoidance Questionnaire (BEAQ), 15 items, rated 1-6. 2. The Cognitive-Behavioural Avoidance Scale (CBAS), 31 items, rated 1-5, measuring different types of avoidance. * Safety Behaviours: Safety Behaviour Scale (SBS), 14 items, rated 0-4. * Self-Efficacy: General Self-Efficacy Scale (GSE), total score 10-40. Higher scores indicate greater self-efficacy. Metacognitions: Metacognition Questionnaire-30 (MCQ-30), total score 30-120. Higher scores indicate more unhelpful metacognitions. Worry: Assessed with the Penn State Worry Questionnaire (PSWQ), 16 items, rated 1-5.
Time frame: Pre-intervention T0, during intervention, post intervention (after 12 weeks of treatment, also knows as T9) and at the 12 month follow-up
Plan to share: No
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