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/24438712Actively Recruiting
Led by ProPersona · Updated on 2025-05-29
170
Participants Needed
1
Research Sites
25 weeks
Total Duration
P
ProPersona
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
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
Exposure Therapy for Late-life Anxiety
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
RadboudUMC
Nederland, Nijmegen, Netherlands, 6525EZ
Actively Recruiting
G
Gert-Jan Hendriks, Professor
N
Nessa Ikani, Asst. Prof.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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