Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06770517

Defeating Fear With Exposure Therapy Delivered by Mental Health Nurses in Primary Care for Anxiety Disorders in Older Adults - a Cluster-randomised Controlled Trial

Led by ProPersona · Updated on 2025-05-29

170

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

P

ProPersona

Lead Sponsor

R

Radboud University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the cost-effectiveness and impact of exposure therapy (ET) delivered by trained mental health nurses (MHNs) compared to usual care (UC) for older adults with anxiety disorders in primary care settings. The study focuses on people aged 65 and older diagnosed with anxiety disorders such as Generalized Anxiety Disorder, Agoraphobia, Panic Disorder, or Social Anxiety Disorder. It aims to address the underdiagnosis and undertreatment of anxiety in older adults, considering patient preferences and barriers like age-related changes and transportation issues. Participants in the ET group will receive eight therapy sessions over 12 weeks, with the first session lasting 60 minutes and the remaining sessions 30 minutes each. These sessions are tailored to individual needs and delivered by MHNs working in primary care centers. The UC group will receive standard care based on general practitioner guidelines, which may include medication, e-learning, psycho-education, problem-solving therapy, or referral to mental health institutions. Throughout the study, participants will complete questionnaires before, during, and after treatment, with follow-ups extending to one year. Researchers will assess anxiety severity using the Geriatric Anxiety Inventory, quality of life with the EuroQol 5 Dimension 5 Level version, and societal costs through a psychiatric illness cost questionnaire. The study will also monitor secondary outcomes like depressive symptoms, general functioning, and medication use. Participation involves no known risks, and the study expects to provide insights into improving anxiety care for older adults.

CONDITIONS

Brief Title

Exposure Therapy for Late-life Anxiety

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A primary DSM-5 anxiety disorder diagnosed using the Mini Internationaal Neuropsychiatrisch Interview (MINI)
  • Diagnosis of Generalized Anxiety Disorder, Agoraphobia, Panic Disorder, or Social Anxiety Disorder
  • Sufficient proficiency in Dutch language
Not Eligible

You will not qualify if you...

  • Presence of somatic or other psychiatric conditions that interfere with diagnosis or treatment
  • Moderate to severe suicidality as determined by the MINI
  • Chronic and interfering substance or alcohol abuse
  • Previous psychotherapy including exposure therapy within the past year
  • Cognitive impairment indicated by a score below 18 on the MoCa test
  • Terminal illness
  • Use of antidepressants and benzodiazepines allowed only if on stable dose for at least 8 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants receive exposure therapy consisting of 8 sessions delivered by a trained mental health nurse over 12 weeks. The first session lasts 60 minutes, followed by seven 30-minute sessions tailored to participant needs and symptoms. Participants in the usual care group receive standard care based on general practitioner guidelines for anxiety disorders.

8 therapy sessions over 12 weeks

Follow-up

Duration - 1 year

Participants are monitored for anxiety symptoms, quality of life, and other outcomes for one year after treatment completion to assess lasting effects of the therapy or usual care.

Visits at 3, 6, 9, and 12 months post-treatment

Trial Site Locations

Total: 1 location

1

RadboudUMC

Nederland, Nijmegen, Netherlands, 6525EZ

Actively Recruiting

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Research Team

G

Gert-Jan Hendriks, Professor

N

Nessa Ikani, Asst. Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force.

Sean D Sullivan, Josephine A Mauskopf, Federico Augustovski...

https://pubmed.ncbi.nlm.nih.gov/24438712

Late life anxiety is associated with decreased memory and executive functioning in community dwelling older adults.

Brian P Yochim, Anne E Mueller, Daniel L Segal

https://pubmed.ncbi.nlm.nih.gov/23298889

Efficacy and effectiveness of psychological interventions on co-occurring mood and anxiety disorders in older adults: A systematic review and meta-analysis.

Viviana M Wuthrich, Denise Meuldijk, Tess Jagiello...

https://pubmed.ncbi.nlm.nih.gov/33368598

Cognitive-behavioral therapy for panic disorder with agoraphobia in older people: a comparison with younger patients.

Gert-Jan Hendriks, Mirjam Kampman, Ger P J Keijsers...

https://pubmed.ncbi.nlm.nih.gov/24867666

Systematic Review of the Clinical Application of Exposure Techniques to Community-Dwelling Older Adults with Anxiety.

Nimali Jayasinghe, Lucy Finkelstein-Fox, Lili Sar-Graycar...

https://pubmed.ncbi.nlm.nih.gov/28452667