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| ID | Type | Description | Link |
|---|---|---|---|
| 10390022210020 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure therapy | Experimental | 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. |
|
| Usual Care group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
Both questionnaires will be used during the 12-week treatment period and during the 1-year follow-up. | 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.
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gert-Jan Hendriks, Professor | Contact | +31510038897 | g.hendriks@propersona.nl | |
| Nessa Ikani, Asst. Prof. | Contact | n.ikani@tilburguniversity.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dominique NJ Rijkelijkhuizen, MSc | ProPersona | Study Chair |
| Özge Baturlar, MSc | ProPersona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Recruiting | Nederland | Nijmegen | 6525EZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24438712 | Background | Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, Orlewska E, Penna P, Rodriguez Barrios JM, Shau WY. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014 Jan-Feb;17(1):5-14. doi: 10.1016/j.jval.2013.08.2291. Epub 2013 Dec 13. | |
| 35325683 |
| Label | URL |
|---|---|
| DeFEAD65+ is based on the BEATDeP (Behavioural activation for depression among older adults) study | View source |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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First assessments will be applied by project researchers and the following assessments will be applied by independent research assistants who are blinded for the condition.
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| Usual Care | Behavioral | 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. |
|
| Pre-intervention T0, post-intervention (12-week), 3-month FU, 6- month FU, 9-month FU, 12-month FU |
| 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.
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. | Pre-intervention T0, during intervention, post intervention (after 12 weeks of treatment, also knows as T9) and at the 12 month follow-up |
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| 36399234 | Background | Knowles KA, Tolin DF. Mechanisms of Action in Exposure Therapy. Curr Psychiatry Rep. 2022 Dec;24(12):861-869. doi: 10.1007/s11920-022-01391-8. Epub 2022 Nov 18. |
| 23298889 | Background | Yochim BP, Mueller AE, Segal DL. Late life anxiety is associated with decreased memory and executive functioning in community dwelling older adults. J Anxiety Disord. 2013 Aug;27(6):567-75. doi: 10.1016/j.janxdis.2012.10.010. Epub 2012 Nov 6. |
| 32007734 | Background | Buchholz JL, Abramowitz JS. The therapeutic alliance in exposure therapy for anxiety-related disorders: A critical review. J Anxiety Disord. 2020 Mar;70:102194. doi: 10.1016/j.janxdis.2020.102194. Epub 2020 Jan 18. |
| 33634922 | Background | Saif-Ur-Rahman KM, Mamun R, Eriksson E, He Y, Hirakawa Y. Discrimination against the elderly in health-care services: a systematic review. Psychogeriatrics. 2021 May;21(3):418-429. doi: 10.1111/psyg.12670. Epub 2021 Feb 26. |
| 33368598 | Background | Wuthrich VM, Meuldijk D, Jagiello T, Robles AG, Jones MP, Cuijpers P. Efficacy and effectiveness of psychological interventions on co-occurring mood and anxiety disorders in older adults: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2021 Jun;36(6):858-872. doi: 10.1002/gps.5486. Epub 2021 Jan 2. |
| 24867666 | Background | Hendriks GJ, Kampman M, Keijsers GP, Hoogduin CA, Voshaar RC. Cognitive-behavioral therapy for panic disorder with agoraphobia in older people: a comparison with younger patients. Depress Anxiety. 2014 Aug;31(8):669-77. doi: 10.1002/da.22274. Epub 2014 May 27. |
| 28452667 | Background | Jayasinghe N, Finkelstein-Fox L, Sar-Graycar L, Ojie MJ, Bruce ML, Difede J. Systematic Review of the Clinical Application of Exposure Techniques to Community-Dwelling Older Adults with Anxiety. Clin Gerontol. 2017 May-Jun;40(3):141-158. doi: 10.1080/07317115.2017.1291546. Epub 2017 Feb 6. |
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| 22581482 | Background | Beesdo-Baum K, Jenjahn E, Hofler M, Lueken U, Becker ES, Hoyer J. Avoidance, safety behavior, and reassurance seeking in generalized anxiety disorder. Depress Anxiety. 2012 Nov;29(11):948-57. doi: 10.1002/da.21955. Epub 2012 May 11. |
| 18165458 | Background | Benitez CI, Smith K, Vasile RG, Rende R, Edelen MO, Keller MB. Use of benzodiazepines and selective serotonin reuptake inhibitors in middle-aged and older adults with anxiety disorders: a longitudinal and prospective study. Am J Geriatr Psychiatry. 2008 Jan;16(1):5-13. doi: 10.1097/JGP.0b013e31815aff5c. |
| 15877708 | Background | Schuurmans J, Comijs HC, Beekman AT, de Beurs E, Deeg DJ, Emmelkamp PM, van Dyck R. The outcome of anxiety disorders in older people at 6-year follow-up: results from the Longitudinal Aging Study Amsterdam. Acta Psychiatr Scand. 2005 Jun;111(6):420-8. doi: 10.1111/j.1600-0447.2005.00531.x. |
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