Defeating Fear with Exposure therapy delivered by mental health nurses in primary care for Anxiety Disorders in older adults - a cluster-randomized controlled trial

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 health care providers, which often include long, costly
treatment trajectories. Exposure is well-suited to be delivered by mental
health nurses (MHNs; or POH-GGZ in Dutch) in primary care centres (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.

We hypothesize that ET (8 sessions in 12 weeks), performed by trained MHNs will
be more effective and cost-effective in reducing anxiety symptoms and improving
quality of life of older adults suffering from anxiety disorders from
pre-treatment to post-treatment and in the 1 year follow-up, compared to Usual
Care (UC).

The primary objective of this study is to evaluate the (cost-)effectiveness of
ET for late-life anxiety disorders delivered by trained MHNs in primary care,
in terms of anxiety and quality of life, compared to UC. UC is not restricted,
and the GP is encouraged to work according to the guidelines of the Dutch
College of GPs.

a. The secondary objectives include investigating whether there are differences
regarding secondary outcomes, such as disorder-specific anxiety symptoms,
comorbid depressive symptoms, general functioning (i.e. disability and mental
health related quality of life) and the use of psychoactive medications (i.e.,
antidepressants and benzodiazepines) between ET and UC from pre- to
post-treatment as well as follow-up, without adding specific interventions
designed to improve these outcomes.

b. Moreover, various predictors and moderators of the treatment outcomes will
be explored, including cognitive functioning, ageism in both the participants
and MHNs, therapeutic alliance and expectations about the treatment.

c. Furthermore, we aim to investigate potential mechanisms of change in ET for
late-life anxiety by utilizing self-report measures and exposure log
worksheets/registration forms. Specifically, we will examine the role of
changes in threat expectancy, avoidance and safety behaviours, self-efficacy,
metacognitions (i.e. beliefs about cognition) and worry during the treatment
phase.

The design of this study is a multi-centre cluster-randomised controlled trial
in PCCs with two parallel treatment groups: a) ET (n = 85) and b) UC (n = 85).

One group will receive ET and the other group will receive UC for their anxiety
symptoms in primary care. Patients assigned to ET will receive 8 (30-minute)
sessions within 12 weeks and homework assignments, with the first session
lasting 45-60 minutes, delivered by trained MHNs.

ET, a well-established psychological intervention, has shown efficacy and
safety in younger and middle-aged individuals. Limited research in older age
groups (65 years and above) also indicates positive trends in both safety and
efficacy. While every psychological intervention carries some inherent risk,
contrary to common concern, there is no evidence suggesting that planned
exposures pose a greater risk than any other psychological intervention. Thus,
potential risk associated with participating in this study can be regarded as
negligible.

The time and burden of participating in this study is considered acceptable.
This was discussed with a focus group of older individuals, including experts
by experience from the patient association for anxiety disorders (ADF
Foundation) and visitors to Ons Raadhuis, a meeting center for older adults in
the study region. They indicated that the burden was manageable, provided that
questionnaires could be completed digitally or on paper/pencil with support.
Additionally, the Exposure Treatment of 8 sessions over 12 weeks was also
considered acceptable. The focus group expressed concerns that older
individuals might be spared treatment due to age or perceived frailty rather
than the treatment being too burdensome. It was felt that assuming an Exposure
Treatment might be too heavy was underestimating older adults' capabilities to
decide for themselves.

It's worth noting that in the previous study we conducted (NL54470.091.16), we
achieved successful participation from older adult patients with depression in
a similar setting. Comparing the target populations, it's reasonable to
anticipate higher participation among anxious older adults, as they typically
exhibit more energy compared to patients with depression who often experience
energy loss. Moreover, potential challenges related to our target population
are addressed by offering the option to complete questionnaires at home, either
with independent research assistants present or via telephone.

Overall, although participation in this study requires a time commitment from
patients, we anticipate that they will benefit from the offered exposure
therapy, leading to an improvement in their anxiety symptoms.