Exposure Therapy for Late-life Anxiety

Not Applicable

Not yet recruiting

• Conditions: Anxiety Disorders; Anxiety Depression

• Registration Number: NCT06770517
• Lead Sponsor: ProPersona

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-12-11
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-01-25
• Primary Completion: 2028-06-23
• Study Completion: 2028-12-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• A primary DSM-5 anxiety disorder using the Mini Internationaal Neuropsychiatrisch Interview (MINI).
• One of the following DSM-5 anxiety disorders will be diagnosed, Generalized Anxiety Disorder, Agoraphobia, Panic Disorder or Social Anxiety Disorder.
• Participants are required to be sufficient in Dutch.

Exclusion Criteria

• Exclusion criteria include somatic and/or another psychiatric morbidity that could interfere with diagnosing or treatment.
• Moderate to severe suicidality, which will be determined using the MINI
• Chronic and interfering substance or alcohol abuse
• Having received previous psychotherapy including exposure in the past year. -
• Antidepressants and benzodiazepines use are allowed if on a stable dose for a minimum of 8 weeks.
• Participants will be excluded if they score lower than 18 points on the MoCa (115). A score of <18 is indicative for moderate to severe cognitive impairment. - Participants will be excluded if they are terminally ill.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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?	Pre-intervention T0, post-intervention (12-week), 3-month FU, 6- month FU, 9-month FU, 12-month FU	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.