Anxiety DisordersDeFEAD65+NCT06770517
Exposure Therapy for Late-life Anxiety
A study testing Exposure therapy in people with Anxiety Disorders and Anxiety Depression, run by ProPersona at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety Disorders, Anxiety Depression
- What is being tested?
- Exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Feb 2025to 19 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nessa Ikani, Asst. Prof. contact
Netherlands1 site, 1 recruiting
- Recruiting
RadboudUMC
Nederland, Nijmegen, 6525EZ
Tim Olde Hartman, doctor, +31624796841, tim.oldehartman@radboudumc.nl
Gert-Jan Hendriks, professor, 0610038897, g.hendriks@propersona.nl
About this study
Official title: Defeating Fear With Exposure Therapy Delivered by Mental Health Nurses in Primary Care for Anxiety Disorders in Older Adults - a Cluster-randomised Controlled Trial
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.
Read the 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.
- Conditions
- Anxiety Disorders, Anxiety Depression
- Being tested
- Exposure therapy, Usual Care
- Keywords
- exposure therapy, anxiety disorders, older adults, late-life anxiety, primary care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapyBehavioural
Also called Cognitive behavioral 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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
- 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.
- 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.
Measured: 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.
- For the cost-effectiveness analysis Quality-Adjusted Life-Years (QUALYs) will be assessed with the EQ-5D-5L.
- Anxiety severity will be assessed with the Geriatric Anxiety Inventory (GAI). Total scores range from 0 to 20, with higher scores indicating greater anxiety.
- 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.
Measured: 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?
- Social Anxiety: Liebowitz Social Anxiety Scale (LSAS), total score ranging 0-144.
- 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.
- 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.
Measured: Pre-intervention T0, post-intervention (12-week), 3-month FU, 6- month FU, 9-month FU, 12-month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start12 Feb 2025
- Primary completion23 Jun 2028 (estimated)
- Study completion19 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProPersona
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Gert-Jan Hendriks, ProPersona
- Investigators
- Dominique NJ Rijkelijkhuizen, MSc, Study chair, ProPersonaÖzge Baturlar, MSc, Study chair, ProPersona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770517
- Sponsor's protocol ID
- NL87105.091.24
- Other IDs
- 10390022210020
- Acronym
- DeFEAD65+
- Status last verified
- May 2025
- First submitted
- 11 Dec 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24438712Craske 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.
PubMed 35325683Knowles 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.
PubMed 36399234Yochim 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.
PubMed 23298889Buchholz 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.
PubMed 32007734Saif-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.
PubMed 33634922Wuthrich 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.
PubMed 33368598Hendriks 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.
PubMed 24867666Jayasinghe 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.
PubMed 28452667Abramowitz 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.
PubMed 24094780Beesdo-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.
PubMed 22581482Benitez 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.
PubMed 18165458Schuurmans 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.
PubMed 15877708Mohlman 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.
PubMed 21463061Kessler 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.
PubMed 30380336
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defeating Fear With Exposure Therapy Delivered by Mental Health Nurses in Primary Care for Anxiety Disorders in Older Adults - a Cluster-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06770517
- Acronym / sponsor ID
- DeFEAD65+ / NL87105.091.24
- Conditions
- Anxiety Disorders, Anxiety Depression
- Keywords
- exposure therapy, anxiety disorders, older adults, late-life anxiety, primary care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- ProPersonaUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 23 Jun 2028 (estimated)
- Study completion
- 19 Dec 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure therapy | Experimental | Behavioral: Exposure therapyThe 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 | Behavioral: Usual CareThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure therapyAlso: Cognitive behavioral therapyThe 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. | Behavioural | Exposure therapy |
| Usual CareThe 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. | Behavioural | Usual Care group |
Primary outcome
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?
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
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?
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
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.
1 secondary outcome
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?
Time frame: Pre-intervention T0, post-intervention (12-week), 3-month FU, 6- month FU, 9-month FU, 12-month FU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 24438712Sullivan 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.
- Background: PubMed 35325683Craske 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.
- Background: PubMed 36399234Knowles 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.
- Background: PubMed 23298889Yochim 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.
- Background: PubMed 32007734Buchholz 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.
- Background: PubMed 33634922Saif-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.
- Background: PubMed 33368598Wuthrich 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.
- Background: PubMed 24867666Hendriks 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.
- Background: PubMed 28452667Jayasinghe 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.
- Background: PubMed 24094780Abramowitz 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.
- Background: PubMed 22581482Beesdo-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.
- Background: PubMed 18165458Benitez 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.
- DeFEAD65+ is based on the BEATDeP (Behavioural activation for depression among older adults) studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nessa Ikani, Asst. Prof. contact
Dominique NJ Rijkelijkhuizen, MSc study chair
ProPersona
Özge Baturlar, MSc study chair
ProPersona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure therapy in people with Anxiety Disorders and Anxiety Depression, run by ProPersona at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gert-Jan Hendriks, Professor (+31510038897, g.hendriks@propersona.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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? (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770517, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.