The primary objective of this research is to asses the effect whether an intensive exposure treatment for older patients (aged 65 years and older) with anxiety and- or compulsive disorders is suitable for this target group and leads to a decrease in…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate whether the intensive exposure
treatment of 8 weeks leads to a reduction in complaints with older patients
with anxiety or obsessive-compulsive disorders, measured with the Geriatric
Anxiety Inventory (GAI) and disorder-specific questionnaires.
Secondary outcome
The secondary objective is whether the treatment leads to a reduction in
depressive symptoms and an improvement in the perceived quality of life as
well. Feasibility is operationalized in the number of completed therapy
sessions, the rate of dropout and satisfaction with the treatment.
Background summary
As a result of the aging population, there is an increasingly large group of
people over 65 years old and of all psychiatric diagnoses, anxiety disorders
are the most common in this group. Cognitive behavioral therapy (CBT) with
exposure as a crucial part has been the golden standard for years when it comes
to treating adults with anxiety and obsessive-compulsive disorders.
Unfortunately, not much scientific research on the effect of this treatment in
the elderly population has been conducted. Besides that it appears that there
is a tendency to apply exposure less often in this target group, as a result of
the phenomenon of 'ageism' (stereotypical prejudices relative to others or
ourselves based on older age). There is therefore an urgent need for more
information about the effect and feasibility of cognitive behavioral therapy
with exposure in older clients with anxiety and obsessive-compulsive disorders.
Intensive forms of CBT (consisting of more than two appointments per week),
with an emphasis on exposure, are very common in specialist mental health care.
The aim of these intensive treatments is to optimize and/or accelerate the
effect of treatment. Based on extensive clinical experiences of the expertise
center Overwaal, an intensified treatment protocol has been developed for
elderly people with persistent anxiety and obsessive-compulsive disorders who
are referred to specialized mental health care. This study examines the effect
of this eight-week intensive exposure treatment on reported anxiety symptoms.
The suitability and applicability of such a treatment for this target group
will also be examined.
Study objective
The primary objective of this research is to asses the effect whether an
intensive exposure treatment for older patients (aged 65 years and older) with
anxiety and- or compulsive disorders is suitable for this target group and
leads to a decrease in anxiety and also a reduction of additional depressive
symptoms and leads to an improved quality of life.
Study design
This is an effectiveness study in the form of a randomized single case design
with repeated measurements (within-subject time-series design). Participants in
the study are randomly assigned to a baseline that varies in duration and
complaints are monitored in the various phases before, during and after
treatment using biweekly measurements.
Intervention
Participants are offered an individual intensive exposure treatment by a team
of experts, with an intensive phase of 4 weeks with 4 contact moments per week
and a subsequent booster phase of 4 weeks with one contact per week. The
treatment takes place at the locations in Arnhen and Nijmegen.
Study burden and risks
The burden consists of completing questionnaires and conducting interviews. The
questionnaires are administered twice a week via telephone or video call with
an average duration 5-10 minutes during the research period. Four measurements
will also take place throughout the study with an average duration of 60
minutes. These measurements will be linked to a treatment contact if possible.
Participation in the study is voluntary and has no consequences for the
existing treatment offer for the patient. The benefit for participants consists
of possible (accelerated) reduction of anxiety and obsessive-compulsive
symptoms.
Nijmeegsebaan 61
Nijmegen 6525 DX
NL
Nijmeegsebaan 61
Nijmegen 6525 DX
NL
Listed location countries
Age
Inclusion criteria
Patients aged 65 and older who are in treatment or have been registered through
their GP for treatment within the outpatient elderly team of a mental health
care organization in Gelderland (Pro Persona).
They were diagnosed with one of the following anxiety disorders using the Mini
International Neuropsychiatric Interview-Simplified (MINI-S): panic disorder,
with or without agoraphobia, social anxiety disorder, generalized anxiety
disorder, or obsessive-compulsive disorder as a main or additional diagnosis.
Other inclusion criteria for the study are:
1) Willingness and ability to follow the 8-week intensive treatment.
2) Sufficient cognitive abilities (score on the Montreal Cognitive Assessment
(MOCA) of greater than or equal to 18)
3) Able to read and write the Dutch language.
4) Informed consent for the research after extensive oral and written
information.
Exclusion criteria
Exclusion criteria are: an acute psychotic disorder, a severe mood disorder,
severe developmental disorders and substance abuse or dependence. Concomitant
use of antidepressants and benzodiazepines (maximum daily equivalence of 30 mg
oxazepam) is permitted. Participants will be instructed to keep the current
dose constant and to take the medication at regular times throughout the study
period.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85218.091.24 |