Exposure Therapy for Late-life Anxiety

NCT06770517 | Recruiting

• 2 other identifiers: NL87105.091.2410390022210020
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Anxiety Depression

Keywords

exposure therapy; anxiety disorders; older adults; late-life anxiety; primary care

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Secondary Outcomes (1)

• 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

Other Outcomes (2)

• 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?

  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

  Pre-intervention T0, during intervention, post intervention (after 12 weeks of treatment, also knows as T9) and at the 12 month follow-up

Study Arms (2)

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.

Behavioral: Exposure therapy

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.

Behavioral: Usual Care

Interventions

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.

Also known as: Cognitive behavioral therapy

Exposure therapy

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.

Usual Care group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProPersona: lead
• Radboud University Medical Center: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

RadboudUMC

Nederland, Nijmegen, 6525EZ, Netherlands

RECRUITING

Related Publications (20)

• 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.

  PMID: 24438712 BACKGROUND

• 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.

  PMID: 35325683 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.

  PMID: 36399234 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.

  PMID: 23298889 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.

  PMID: 32007734 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.

  PMID: 33634922 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.

  PMID: 33368598 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.

  PMID: 24867666 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.

  PMID: 28452667 BACKGROUND

• 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.

  PMID: 24094780 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.

  PMID: 22581482 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.

  PMID: 18165458 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.

  PMID: 15877708 BACKGROUND

• 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.

  PMID: 21463061 BACKGROUND

• 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.

  PMID: 30380336 BACKGROUND

• 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.

  PMID: 20099273 BACKGROUND

• 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.

  PMID: 10674949 BACKGROUND

• 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.

  PMID: 29494900 BACKGROUND

• 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.

  PMID: 38973756 BACKGROUND

• 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.

  PMID: 37385226 BACKGROUND

Related Links

• DeFEAD65+ is based on the BEATDeP (Behavioural activation for depression among older adults) study

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Implosive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dominique NJ Rijkelijkhuizen, MSc

  ProPersona

  STUDY CHAIR

• Özge Baturlar, MSc

  ProPersona

  STUDY CHAIR

Central Study Contacts

Gert-Jan Hendriks, Professor

CONTACT

+31510038897; g.hendriks@propersona.nl

Nessa Ikani, Asst. Prof.

CONTACT

n.ikani@tilburguniversity.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 13, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): June 23, 2028
• Study Completion (Estimated): December 19, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)