Study Results
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Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2025-02-12
2028-12-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exposure therapy
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.
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 group
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
ProPersona
OTHER
Responsible Party
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Gert-Jan Hendriks
prof.dr.
Principal Investigators
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Dominique NJ Rijkelijkhuizen, MSc
Role: STUDY_CHAIR
ProPersona
Özge Baturlar, MSc
Role: STUDY_CHAIR
ProPersona
Locations
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RadboudUMC
Nederland, Nijmegen, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Craske MG, Treanor M, Zbozinek TD, Vervliet B. Optimizing exposure therapy with an inhibitory retrieval approach and the OptEx Nexus. Behav Res Ther. 2022 May;152:104069. doi: 10.1016/j.brat.2022.104069. Epub 2022 Mar 15.
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.
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.
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.
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.
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.
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.
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.
Abramowitz JS. The practice of exposure therapy: relevance of cognitive-behavioral theory and extinction theory. Behav Ther. 2013 Dec;44(4):548-58. doi: 10.1016/j.beth.2013.03.003. Epub 2013 Mar 13.
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.
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.
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.
Mohlman J. A community based survey of older adults' preferences for treatment of anxiety. Psychol Aging. 2012 Dec;27(4):1182-90. doi: 10.1037/a0023126. Epub 2011 Apr 4.
Kessler EM, Blachetta C. Age cues in patients' descriptions influence treatment attitudes. Aging Ment Health. 2020 Jan;24(1):193-196. doi: 10.1080/13607863.2018.1515889. Epub 2018 Oct 31.
Wolitzky-Taylor KB, Castriotta N, Lenze EJ, Stanley MA, Craske MG. Anxiety disorders in older adults: a comprehensive review. Depress Anxiety. 2010 Feb;27(2):190-211. doi: 10.1002/da.20653.
van Balkom AJ, Beekman AT, de Beurs E, Deeg DJ, van Dyck R, van Tilburg W. Comorbidity of the anxiety disorders in a community-based older population in The Netherlands. Acta Psychiatr Scand. 2000 Jan;101(1):37-45. doi: 10.1034/j.1600-0447.2000.101001037.x.
Hohls JK, Konig HH, Raynik YI, Hajek A. A systematic review of the association of anxiety with health care utilization and costs in people aged 65 years and older. J Affect Disord. 2018 May;232:163-176. doi: 10.1016/j.jad.2018.02.011. Epub 2018 Feb 15.
Hendriks GJ, Janssen N, Robertson L, van Balkom AJ, van Zelst WH, Wolfe S, Oude Voshaar RC, Uphoff E. Cognitive behavioural therapy and third-wave approaches for anxiety and related disorders in older people. Cochrane Database Syst Rev. 2024 Jul 8;7(7):CD007674. doi: 10.1002/14651858.CD007674.pub3.
Janssen NP, Lucassen P, Huibers MJH, Ekers D, Broekman T, Bosmans JE, Van Marwijk H, Spijker J, Oude Voshaar R, Hendriks GJ. Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial. Psychother Psychosom. 2023;92(4):255-266. doi: 10.1159/000531201. Epub 2023 Jun 29.
Related Links
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DeFEAD65+ is based on the BEATDeP (Behavioural activation for depression among older adults) study
Other Identifiers
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10390022210020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL87105.091.24
Identifier Type: -
Identifier Source: org_study_id
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